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Bioanalytical & Bioprocess Bioprocess & HCP ELISA Biosimilar Conformational ELISA Protein Refolding & Aggregation PEGylated & PEG Immunogenicity ELISA Hybridoma Screening Kit Cell Cytotoxicity Assay Endotoxin Recovery, Detection & Removal Agarose Beads & Empty Columns Interfering Protein Removal Kits Lipid Removal & Clarification

Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

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Page 1: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Bioanalytical & Bioprocess

Bioprocess & HCP ELISA

Biosimilar Conformational ELISA

Protein Refolding & Aggregation

PEGylated & PEG Immunogenicity ELISA

Hybridoma Screening Kit

Cell Cytotoxicity Assay

Endotoxin Recovery, Detection & Removal

Agarose Beads & Empty Columns

Interfering Protein Removal Kits

Lipid Removal & Clarification

Page 2: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

PRODUCT NAME CAT. NO.

ENZ-51023

ENZ-51039

®ProteoStat Protein Aggregation Assay

®ProteoStat Protein Aggregation Standards

PRODUCT NAME

ENZ-51027

ENZ-51040

®ProteoStat Thermal Shift Stability Assay

®ProteoStat Protein Refolding & Aggregation Sensing Kit

Optimize & Monitor Biologics Integrity

The ProteoStat® Protein Aggregation Assay is a simple, sensitive, homogeneous fluorescent microplate assay. The novel molecular rotor dye used detects a broad range of different protein aggregates from visible to subvisible particles.

Ÿ Delivers superior results when compared to conventional protein detection dyes (Sypro Orange, Thioflavin T, ANS, Congo Red)

Ÿ High throughput method for monitoring protein stability when used with flow cytometry

Ÿ Convenient, complementary orthogonal method for cross-validation of instrumentation-intensive techniques

Ÿ Useful assay to troubleshoot protein damage, from protein development through manufacturing stage

The ProteoStat® Thermal Shift Stability Assay is a rapid, simple screening method based on a novel molecular rotor dye which detects protein aggregation.

Ÿ

Ÿ Screen for ligand binding to proteins of unknown function

Ÿ Screen protein variants to determine their relative stabilities or excipients to determine optimal protein storage conditions

Ÿ Identify protein-protein interaction inhibitors

Perform accelerated screening for protein stability as a function of pH, ionic strength, and concentration

®ProteoStat Protein Aggregation Assay

®ProteoStat Thermal Shift Stability Assay

CAT. NO.

®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 3: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Protein A ELISA Kit

The Protein A ELISA kit is a sensitive and reproducible sandwich assay to quantify Protein A residuals in monoclonal antibody preparations. This extensively validated ELISA kit enables efficient detection of natural and recombinant Protein A constructs with up to 100% recovery.

Ÿ Detects 1ppm of Protein A residuals in human IgG

Ÿ Recognizes 4 different Protein A variants

Ÿ Useful for contamination analysis and measurement of Protein A variants in monoclonal antibody preparations

Ÿ Produces results in less than 3 hours with low cost per test

Natural

Protein A (Sa)

Millipore

RecombinantProtein A (Ec)

Repligen

Recombinant Cys-Protein A (Ec)

GE

Recombinant alkaline-resistant

Protein A (Ec)

GE MabSelet SuRe

ADI-900-057Protein A ELISA Kit

Bioprocess & Host Cell ProteinELISA Kits

The Host Cell Protein ELISA kits and reagents are ideal for impurity analysis, Host Cell Protein quantitation and Western blots.

Ÿ Quantitatively measures host cell protein contamination in E.Coli and CHO derived biologics

Ÿ High throughput format with results in 2.5 hours

PRODUCT NAME

E. coli Host Cell Protein ELISA Kit*

CHO Host Cell Protein ELISA Kit*

His-Tag ELISA Kit

Bovine Albumin ELISA Kit

ENZ-KIT127

ENZ-KIT128

AKR-130

E11-113

CAT. NO.

Human Albumin ELISA Kit

Bovine IgA ELISA Kit

Bovine IgG ELISA Kit

Human IgA ELISA Kit

Human IgG ELISA Kit

Bovine IgM ELISA Kit

Human IgM ELISA Kit

Bovine Transferrin ELISA Kit

Human Transferrin ELISA Kit

Bovine Lactoferin ELISA Kit

GFP ELISA Kit

E88-129

E11-121

E11-118

E88-102

E88-104

E11-101

E88-100

E10-122

E88-128

E11-122

AKR-121

Antibodies & Protein Standards to detectHCPs using Western blot analysis

HCF1 (hamster), pAb

HCF1 (hamster), pAb (biotin conjugate)

HCF1 (E. coli), pAb (biotin conjugate)

IgG (human), pAb (biotin conjugate)

E. coli Host Cell Protein ELISA Standards

CHO Host Cell Protein ELISA Standards

E.coli HCP Chemiluminescent WB kit

HCF1 (E. coli), pAb

IgG (human), pAb

PRODUCT NAME CAT. NO.

ENZ-PRT121-0050

ENZ-PRT122-0050

KCAJ07

ENZ-ABS260-0100

ENZ-ABS261-0100

ENZ-ABS262-0100

ENZ-ABS263-0100

ENZ-ABS264-1000

ENZ-ABS265-1000

®Contamination Monitoring

*Manufactured under cGMP

Most Sensitive9.01 pg/ml

Assay recognition of different Protein A constructs, post boiling. Resulting concentrations were interpolated from kit standard curve. Percent recovery calculated by dividing observed concentration by expected concentration. A: Natural Protein A from S. aureus (Millipore), n=9; B: Recombinant Protein A from E. coli (Repligen), n=9; C: Recombinant Cys-Protein A from E. coli (GE), n=12; and D: Recombinant alkaline-resistant Protein A variant from E. coli (MabSelet SuRe from GE), n=12; graphical data represents statistical mean +/- 1 standard deviation. Ref.: Enzo Life Sciences

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 4: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Anti-peptide

Antibody

Antibody

Anti-human IgG

Biotinylated

Horse Radish

Peroxidase

H2N NH2

Steptavidin

Oxidized TMB

HN NH

TMB

Protein

Therapeutic

TMBioSims Conformational ELISA Kits

TMThe BioSims Conformational ELISA kits allow for 3-D conformational comparison, higher-order structure (HOS) characterization, between biosimilars and marketed mAb. This new technology provides a sensitive, systematic, and robust measurement of biosimilar conformation comparability at the molecular level.

Ÿ Unique measurement of biosimilar mAb HOS Comparability

Ÿ Detects small amounts of conformational impurity, ≥ 0.1%

Ÿ Correlates well with bioassays and glycosylation analysis

Reduce Hybridoma Screening & Cloning Time by 75%

TMThe DiSH Kit is a unique technology for the rapid production of hybridomas. Using a genetically-modified myeloma partner, the kit creates hybridomas capable of both secreting and surface-expressing antigen-specific antibodies, enabling screening and selection of positive clones by FACS. The components of the kit are available as standalone products as well.

Ÿ Enables faster, improved selection of specific, stable hybridomas

Ÿ Minimizes manipulation of cloned cell lines relative to approaches requiring Limiting Dilution Subcloning (LDS)

Ÿ Decreases time and labor costs

Hybridomas produce secreted antibody AND surface-bound antibody

Label cells with Fluorescent Antigen

Enrich cells with Antigen-coupled

Magnetic Bead Separation

Magnetic beads

Ag

Ag

OR FACS: Fluorescence-Activated Cell Sorting

PRODUCT NAME CAT. NO.

TMDiSH Kit

TMAbeoClone (HAT Semi-solid Medium)

ENZ-71001

ENZ-70004

TMAbeoClone (Base Semi-solid Medium) ENZ-70009

TMAbeoClone (CHO TCSC Semi-solid Medium) ENZ-70010

PRODUCT NAME CAT. NO.

Adalimumab Conformational ELISA

Alemtuzumab Conformational ELISA

Bevacizumab Conformational ELISA

Cetuximab Conformational ELISA

Conserved mAb Sequence Conformational ELISA

Infliximab Conformational ELISA

Palivizumab Conformational ELISA

Rituximab Conformational ELISA

Trastuzumab Conformational ELISA

ENZ-KIT122

ENZ-KIT119

ENZ-KIT118

ENZ-KIT120

ENZ-KIT123

ENZ-KIT124

ENZ-KIT126

ENZ-KIT125

ENZ-KIT121

The sensitive PEGylated Protein ELISA kit is ideal for drug development and pharmaceutical manufacturing applications including drug formulations, pharmacokinetics analysis, drug comparison, lead candidate identification, lot release criteria and in-process QC studies.

Ÿ Validated for a wide range of MW linear and branched PEGs, both in free form and when conjugated to proteins

Ÿ Sensitive assay measures < 1ng/ml of PEGylated molecules

Ÿ Quantifies PEGylated target molecules in complex matrices to allow monitoring of drug levels or its accumulation in tissue

PRODUCT NAME CAT. NO.

PEGylated Protein ELISA Kit ADI-900-213

Improved Screening for Biotherapeutics®

Sensitive detection of linear and branched PEG molecules

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

PEGylated Protein ELISA Kit

Page 5: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

The NIDS® PEG Immunogenicity ELISA provides a complete set of reagents to detect PEG-specific antibodies in human serum and other matrices.

• Double Antigen Bridging Assay in 96-well format

• Extensively tested with human serum samples

• 2.5 hour turnaround time

• Detects Abs to PEGs of various lengths and with different linking groups

• PEG Precoated plates

• Colorimetric, HRP based

• Limit of Detection: 125 ng/mL Ab

• No matrix effects observed

NIDS® PEG Immunogenicity ELISA

Depletion with 30 kDa PEG

Depletion with 40 kDa PEG

Recognizes PEG polymersof various sizes

NIDS® Streptavidin and Neutravidin Coated Plates

The Streptavidin or Neutravidin-coated ELISA plates are often used when coated proteins are in limited quantities or tend to be denatured during a direct coating process. NIDS® HyperBind High Sensitivity and High Binding streptavidin- and neutravidin-coated ELISA plates are available in clear, black, and white formats for colorimetric, fluorescence and chemiluminescence-based assays

PRODUCT NAME CAT. NO.

NIDS® Polyethylene Glycol (PEG) Immunogenicity ELISA Kit 11-1035-1KT

90-1030-10EA

1L-026-1KT

NIDS® DIY Immunogenicity ELISA Kit (10 Plates)

NIDS® PEG Immunogenicity Rapid Assay Kit (100 Tests)

Improved Screening for Biotherapeutics

• High Efficiency Coating

• Ready to use plates, pre-blocked with BSA

• Specific: High signal to noise ratios with low background

• Sensitive: Detection of < 1 ng/mL of protein is easily attainable

• Long shelf life: > 18 months at room temperature

• Low cost: Reduce reagent use by as much as 90%

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

0.10 1.00 10.00 100.00 1000.00 10000.00

A 4

50

/63

0

Molar Ratio PEG: Ab

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

1

0.01 0.1 1 10 100 1000 10000

A 4

50/6

30

Molar Ratio PEG: Ab

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

0.1 1 10 100 1000

A 4

50

/63

0

Molar Ratio PEG: Ab

Depletion with 20 kDa PEG

Improved Screening for Biotherapeutics ®

40 kDa PEG

H

YHRP

H-40 kDa PEG

ANPEG-1

Anti-H-HRP conjugate

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 6: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Sandwich ELISA for mouse IgG using NIDS® HyperBind streptavidin (SA) and neutravidin (NA) plates and the commercially available Pierce SA and NA plates. NIDS® HyperBind plates were coated at 0.5 μg/mL capture Ab and the Pierce plates at 5.0 μg/mL. NIDS® HyperBind plates generate greater signal and sensitivity while using only 10% of the antibody required by the commercial plates. *(Reference: Vallejo YR, Li J, Yin R. Enhancing assay performance using nanoscale detection. IVD Technology, Volume 16, May/June 2010)

PRODUCT NAME

High Sensitivity Plates

NIDS® HyperBind High Sensitivity Streptavidin Coated Clear Solid Plates (96 Well) (5 Plates)

NIDS® HyperBind High Sensitivity Neutravidin Coated Clear Solid Plates (96 Well) (5 Plates)

NIDS® HyperBind High Sensitivity Streptavidin Coated Black Solid Plates (96 Well) (5 Plates)

NIDS® HyperBind High Sensitivity Streptavidin Coated White Solid Plates (96 Well) (5 Plates)

NIDS® HyperBind High Sensitivity Streptavidin Coated Clear Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High Sensitivity Neutravidin Coated Clear Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High Sensitivity Streptavidin Coated Black Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High Sensitivity Neutravidin Coated Black Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High Sensitivity Streptavidin Coated White Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High Sensitivity Neutravidin Coated White Stripwell Plates (96 Well) (300 plates)

High Binding Plates

NIDS® HyperBind High Binding Streptavidin Coated Clear Solid Plates (96 Well) (5 Plates)

NIDS® HyperBind High Binding Neutravidin Coated Clear Solid Plates (96 Well) (5 Plates)

NIDS® HyperBind High Binding Streptavidin Coated Clear Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High Binding Neutravidin Coated Clear Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High Binding Streptavidin Coated Black Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High-Binding Neutravidin Coated Black Stripwell Plate 96-Well (300 plates)

NIDS® HyperBind High Binding Streptavidin Coated White Stripwell Plates (96 Well) (300 plates)

NIDS® HyperBind High-Binding Neutravidin Coated White Stripwell Plate (96-Well) (300 plates)

NIDS® HyperBind High-Binding Neutravidin Coated Black Solid Plate (96-Well) (5 Plates)

11-1001-5PK

11-1007-5PK

12-1001-5PK

13-1001-5PK

21-1001-5PK

21-1007-5PK

22-1001-5PK

22-1007-5PK

23-1001-5PK

23-1007-5PK

11-3001-5PK

11-3007-5PK

21-3001-5PK

21-3007-5PK

22-3001-5PK

22-3007-5PK

23-3001-5PK

23-3007-5PK

12-3007-5PK

CAT. NO.

Improved Screening for Biotherapeutics®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Most sensitive ELISA plates for Serological Assays*streptavidin or neutravidin-coated

Comparison of TSH Assays on HyperBindand Commercial Streptavidin Plates

ANP Pierce HBC Pierce Nunc R&D systems

Binding Efficiency: HyperBind Streptavidin (SA)clear plates vs. commercial plates

Vendor 1 Vendor 2 Vendor 3HyperBind

Sandwich Assay Performance at OptimalCoating Concentrations

HyperBind NA plate,0.5μg/mL capture Ab Vendor 1 NA plate, 5.0μg/mL capture Ab

Page 7: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

NIDS® DIY Biotinylation and Digoxigenin Labeling Kits

NIDS® DIY Biotinylation and Digoxigenin labeling Kits provide an easy way to label peptides and proteins rapidly and efficiently.

• Successfully used in PK and Immunogenicity Assays

• Short and long linkers are available

• Rapid QC test strip confirms successful labeling.

• Compared to other methods, which often require at least 100 µg of the conjugate, our QC procedure consumes only low nanograms of the labeled reagent.

NIDS® DIY Biotin-1500-NHS Antibody Labeling Kit

NIDS® DIY Biotin-1500-NHS Antibody Labeling Kit

NIDS® DIY Biotin-1500-NHS Protein Labeling Kit

NIDS® DIY Biotin-1500-NHS Protein Labeling Kit

NIDS® DIY Digoxigenin-NHS Antibody Labeling Kit

NIDS® DIY Digoxigenin-NHS Antibody Labeling Kit

NIDS® DIY Digoxigenin-NHS Protein Labeling Kit

NIDS® DIY Digoxigenin-NHS Protein Labeling Kit

PRODUCT NAME

90-1018-1KT

90-1018-10KT

90-1017-1KT

90-1017-10KT

90-1024-1KT

90-1024-10KT

90-1023-1KT

90-1023-10KT

CAT. NO.ANTIBODY/PROTEIN

AMOUNT

Sandwich Pharmacokinetics Assay Sandwich Immunogenicity Assay

Up to 2 mg

Up to 20 mg

Up to 2 mg

Up to 20 mg

Up to 2 mg

Up to 20 mg

Up to 2 mg

Up to 20 mg

Improved Screening for Biotherapeutics ®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Rapid QC Test Strips provided with the kit for confirmation of successful labeling of proteins

Page 8: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Improved Screening for Biotherapeutics®

A simple and easy-to-use kit capable of irreversible removal of interfering endogenous proteins such as drug target compounds, which can cause erroneous results in immunogenicity and PK assays

NIDS® NPX4000 Interfering Protein Removal Kits

PRODUCT NAME CAT. NO.

NIDS® NPX4000 Interfering Protein Extraction Kit (100 samples) (Generic DIY Kit) 90-1026

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

• Irreversibly removes >99% of endogenous interfering protein or drug target in patient samples

• Highly efficient & does not affect original ADA levels

• Simple extraction procedure easily adaptable to high throughput testing

• Significantly greater capacity than microparticles

• Capable of removing up to 400 ng/mL of interfering proteins

• Uses up to 100-fold less capture reagent than microparticles

• Suitable for all bioanalytical methods including PK and IM assays

Effect of Removal of Target Interference on an Immunogenicity Assay For a Biotherapeutic Monoclonal Antibody Using NPX4000 Extraction Particles

0 1 10 100

[Interfering Protein] ng/mL0 1 10 100

Sign

al

Before Extraction After Extraction

YY

Y Y

YY

YY

Y

NPX4000Particles

Serum Sample

Centrifugation

NPX4000 nanoparticles with scavenger/capture reagentY

Interfering protein

Use this kit to attach the specific blocking antibody or receptors to activated nanoparticles and pretreating the sample, followed by a centrifugation step, enables irreversible removal of interference without affecting the dection of ADAs

Page 9: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

PRODUCT NAME PRODUCT NAME PRODUCT NAME PRODUCT NAMECAT. NO. CAT. NO.CAT. NO. CAT. NO.

NIDS® NPX4000 INTERFERING PROTEIN REMOVAL KITS

90-1147

90-1148

90-1149

90-1150

90-1151

90-1152

90-1153

90-1154

90-1155

90-1156

90-1157

90-1158

90-1159

90-1160

90-1161

90-1162

90-1163

90-1164

90-1165

90-1166

90-1167

90-1168

90-1169

90-1170

90-1171

90-1172

90-1173

90-1174

90-1175

90-1176

90-1177

90-1178

IL-12 p70

IL-13

IL-15

IL-16

IL-17

IL-1A

IL-1B

IL-1RA

IL-2

IL-3

IL-4

IL-5

IL-6

IL-6R

IL-7

IL-8

I-TAC

Leptin

LIGHT

Lymphotactin

MCP-1

MCP-2

MCP-3

MCP-4

M-CSF

MDC

MIF

MIG

MIP-1A

MIP-1B

MIP-1D

MIP-3A

90-1179

90-1180

90-1181

90-1182

90-1183

90-1184

90-1185

90-1186

90-1187

90-1188

90-1189

90-1190

90-1191

90-1192

90-1193

90-1194

90-1195

90-1196

90-1197

90-1198

90-1199

90-1200

90-1201

90-1202

90-1203

90-1204

90-1205

90-1206

90-1207

90-1208

90-1209

90-1210

MIP-3B

MSP-A

NAP-2

NT-3

NT-4

OPG

OSM

PARC

PCSK9

PDGF-BB

PIGF

RANTES

RF

SCF

SDF-1

sgp130

TARC

TECK

TGF-beta 1

TIMP-1

TIMP-2

TNF RI

TNF RII

TNF-a

TNF-b

TPO

TRAIL R3

TRAIL R4

TrkA

uPAR

VEGF

VEGF-D

Acrp30

AgRP

Amphiregulin

ANG

Angiopoietin-1

AXL

BDNF

bFGF

BLC

BMP-4

BMP-6

b-NGF

BTC

CCL28

CD28

CD3 epsilon

CD39/ENTPD1

CD4

CD5

Ck beta 8-1

CNTF

CTACK

Dtk

EGF

EGF-R

ENA-78

Eotaxin

Eotaxin-2

Eotaxin-3

EPO

ErbB2

Fas

90-1095

90-1096

90-1097

90-1098

90-1099

90-1100

90-1101

90-1102

90-1103

90-1104

90-1105

90-1106

90-1107

90-1108

90-1109

90-1110

90-1111

90-1112

90-1113

90-1114

90-1083

90-1084

90-1085

90-1086

90-1087

90-1088

90-1089

90-1090

90-1091

90-1092

90-1093

90-1094

FGF-4

FGF-6

FGF-7

FGF-9

Flt-3 ligand

Fractalkine

GCP-2

GCSF

GDNF

GITR

GITR-ligand

GM-CSF

GRO-A

HCC-4

HER2neu receptor

HGF

hGH

I-309

ICAM-1

ICAM-3

IFN-gamma

IFN ß-1a

IGF-1

IGF-1 SR

IGFBP-1

IGFBP-2

IGFBP-3

IGFBP-4

IGFBP-6

IL-10

IL-11

IL-12 p40

90-1115

90-1116

90-1117

90-1118

90-1119

90-1120

90-1121

90-1122

90-1123

90-1124

90-1125

90-1126

90-1127

90-1128

90-1129

90-1130

90-1131

90-1132

90-1133

90-1134

90-1135

90-1136

90-1137

90-1138

90-1139

90-1140

90-1141

90-1142

90-1143

90-1144

90-1145

90-1146

®

List of 140 target proteins which can be extracted from test samples using specific antibodies. We can also prepare the specific extraction nanoparticle kit for your unique requirements.

Improved Screening for Biotherapeutics

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 10: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

TMaCella -TOX - Bioluminescence non-radioactive cytotoxicity Assay

A bioluminescence, non-radioactive cytotoxicity assay designed to quantitatively measure the release of glyceraldehyde-3-phosphate dehydrogenase (GAPDH) from mammalian cell lines or bacterial cells.

TMaCella -TOX use the same general ADCC and CDC processes where target cell apoptosis is induced. This lysis leads to the release of endogenous GAPDH, an enzyme in glycolysis and gluconeogenesis pathways, from the cytoplasm. Through the addition of coupling enzymes, adenosine triphosphate (ATP) is generated, and when coupled to a luciferase/luciferin reaction, produces a measureable bioluminescent signal. This signal is proportional to the amount of GAPDH release and target cell lysis.

CLATOX100-3500

CLATOX100-3L500

CLATOX100-3P500

CLATOX100-41000

PRODUCT NAME CAT. NO.TEST

Non Radioactive Cytotoxicity Assay - aCella -TOXTM

Non Radioactive Cytotoxicity Assay - aCella -TOX (5 Lumi Plates)TM

Non Radioactive Cytotoxicity Assay - aCella -TOX (5 Lumi Plates + 5 Tissue Culture Plates)TM

Non Radioactive Cytotoxicity Assay - aCella -TOXTM

Specifications & Advantages

Versatile - Useful for measuring activity of T Cells, Primary Cells, NK, complement and other lytic agents. Assay can be run in serum supplemented media.

FAST - Results in 3-5 minutes. Chromium 51 or europium release for measurement are time consuming. The inherent sensitivity of luciferase detection is enhanced by the amplification effect of enzyme turnover, which produces thousands, millions or billions of high - energy molecules for each molecule of the enzyme.

Highly Sensitive - Can detect fewer than 500 cells/well in the presence of serum or as few as 10 cells/well in serum-free or heat killed media.

GAPDH- The fact that GAPDH is a natural component of cells, and does not need to be introduced into the cells in any manner, distinguishes this assay from all methods which require prelabelling of cells, transfection, transformation, or other methods of introducing proteins or other molecules into the target cells in order to generate a signal in a later step.

Advantages for measurement of cell mediated or complement mediated cytolysis - It is usually desirable to use smaller numbers of TCells than are needed for the 51Cr – release assay, since excessive numbers of effector cells can

TMincrease the background signal. This is now possible due to the high sensitivity of aCella -TOX.

Improved Screening for Biotherapeutics®

TMaCella -TOX assay principle

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 11: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

SMA

LL M

OLE

CU

LES

CEL

L D

EATH

OX

IDA

TIV

E ST

RES

S

Simplify your cell death analysis

Cyto-ID® Autophagy Detection Kit (ENZ-51031)

• No transfection required• Protocol validated with known

inhibitors and activators • Rapidly quantifies autophagy

in native heterogeneous cell populations

• Negligible staining of lysosomes reducing background

GFP-Certified Apoptosis/Necrosis Detection Kit (ENZ-51002)

• True multiplexing capabilities with GFP and other green fluorescent probes

• Readily distinguishes between healthy, early apoptotic, late apoptotic and necrotic cells

• Optimized for both fluorescence microscopy and flow cytometry

TM

Sensitive assays for oxidative stress

High-throughput analysis of mitotoxicity

Cyto-ID® Hypoxia/Oxidative Stress Detection Kit (ENZ-51042)

• Sensitive hypoxia dye fluoresces red when converted by nitroreductates

• Total ROS dye enables simultaneous detection of hypoxia (red) and ROS (green)

• Non-toxic, cell permeable dye optimized to avoid artifactual fluorescence

• Suitable for microscopic or flow cytometry analysis of adherent or suspension cells

Mito-ID® Membrane Potential Cytotoxicity Assay Kit (ENZ-51019)

• 10x more sensitive than JC-1 with superior aqueous solubility

• Photostable dual-emission dye• Separate Mito-ID® Red/Green

assays available for detection of mitochondrial mass

• Suitable for high-throughput applications

Bioactives for Drug Development

Ultra-high Purity | Cost effective | Extensively Validated

PRODUCT NAME CAT. NO.

Compound Libraries

Autophagy Library BML-2837

Cardiotoxicity Library BML-2850

Hepatotoxicity Library BML-2851

Hematopoietic Toxicity Library BML-2852

ICCB Known Bioactives Library BML-2840

FDA Approved Drug Library V2 BML-2843

Bioactive Lipid Library BML-2800

Protease Inhibitor Library

Nephrotoxicity Library

BML-2833

ENZ-LIB100

PRODUCT NAME

Autophagy Modulators

3-Methyladenine

LY 294002

Rapamycin

Wortmannin

Osmotic Stress Inhibitors

JX-401

PD 169,316

SB202190

SB220025

Protease Inhibitors

Protease Inhibitor Cocktail

3,4-Dichloroisocoumarin

Actinonin

Chymostatin

Cystatin C (human)

CAT. NO.

BML-ST420

BML-ST415

BML-EI366

ALX-270-258

BML-EI294

ALX-270-325

BML-KI103

BML-PI110

ALX-260-128

ALX-260-005

ALX-850-292

BML-AP502

BML-A275

Solutions for Bioprocess Optimization ®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 12: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Cleanascite™ - Lipid adsorption and clarification reagent

Ÿ A high binding capacity for lipids with minimal cross-reactivity with proteins

Ÿ Effectively replaces chlorinated/fluorinated hydrocarbons (eg. freon) and it is environmentally friendly.

Ÿ Very low protein binding

Ÿ Does not bind to DNA, RNA, enzymes and proteins

Ÿ Extends the life of membrane and chromatographic columns.

Clarifies:-

• 5

Ascites

• 2

Serum/Plasma

• 7

Bile

• Cohn Paste

• 3

Cell Lysates

• 6

Tissue Culture

• Organ Homogenates

• 4

Saliva/Sputum

• Egg Yolk

• Transgenic Milk

Cleanascite™

Cleanascite™

Cleanascite™

Cleanascite™

100 ml

1 Liter

4 Liters

16 Liters

400 ml

4 Liters

16 Liters

64 Liters

X2555 -100

X2555- 1000

X2555- 4000

X2555- 16000

PRODUCT NAME SIZE CAT. NO.TOTAL SAMPLE VOLUME THAT CAN BE PROCESSED*

TMTreatement With Cleanascite

Insert: PAGE showingLeft: MarkersRight: IgY and other major protein fractionrecovered

Ideal reagent for delipidation treatments fordownstream processing of large-scale therapeuticproteins, enzymes and monoclonal antibodies.

Egg Yolk After (Left) and Before (Right)

Quality & Purity of Biotherapeutics®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Cleanascite™ selectively removes lipids, cell debris, lipoproteins, floating fats, impurities from Cohn paste, transgenic milk, egg yolk and biological samples for pretreatment of samples prior to purification.

The reagent is a solid-phase, non-ionic adsorbent supplied as a suspension in saline, ready for use. Simply add, centrifuge and/or filter. The clarified supernatant is ready for subsequent downstream processing or analysis.

*Based on Cleanascite™ to Sample typical volume ratio. Volume ratio may be adjusted according to lipid levels.

Page 13: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Agarose Beads for purification of Proteins

We offers a wide range of activated agarose beads for affinity chromatography and enzyme and antibody immobilization processes, as well as a variety of non-activated agarose beads for size exclusion chromatography.

PRODUCT NAME CAT. NO. PACK SIZE PRODUCT NAME CAT. N O. PACK SIZE PRODUCT NAME CAT. NO. PACK SIZE

AFFINITY CHROMATOGRAPHY PURIFICATION

HIS-TAG PURIFICATION

LOW PRESSURE: CHELATING AGAROSE BEADS: BULK RESINS

HIGH Density METAL FREE

HIGH Density NICKEL

HIGH Density ZINC

HIGH Density COBALT

LOW Density METAL FREE

LOW Density NICKEL

LOW Density ZINC

LOW Density COPPER

NICKEL CHELATE KIT 6BCL-KNi-2

NICKEL CHELATE KIT + 20 empty mini columns

6BCL-KNiSP-2

NICKEL & COBALT CHELATE KIT 6BCL-KNiCo-2

NICKEL & COBALT CHELATE KIT + 30 empty mini columns

6BCL-KNiCoSP-2

ZINC CHELATE KIT 6BCL-KZn-2

ZINC CHELATE KIT + 20 empty mini columns

6BCL-KZnSP-2

ZINC & COPPER CHELATE KIT 6BCL-KZnCu-2

ZINC & COPPER CHELATE KIT + 30 empty mini columns

6BCL-KZnCuSP-2

HIGH DENSITY CHELATE KIT

Quality & Purity of Biotherapeutics ®

HIGH DENSITY CHELATE KIT + 40 empty mini columns

LOW DENSITY CHELATE KIT

LOW DENSITY CHELATE KIT + 40 empty mini columns

LOW PRESSURE: NTA AGAROSE BEADS: BULK RESINS

NICKEL NTA Agarose Resin

HIGH PRESSURE: CHELATING RAPID RUN™ BEADS: BULK RESINS

NICKEL RAPID RUN™

5 ml

25 ml

100 ml

500 ml

COBALT RAPID RUN™

5 ml

25 ml

HIGH PRESSURE: RAPID RUN™ AGAROSE BEADS: PRE-PACKED COLUMNS

25 ml

100 ml

500 ml

100 ml

500 ml

ANTIBODY PURIFICATION

6BCL-KH-2

6BCL-KHSP-2

6BCL-KL-2

6BCL-KLSP-2

6NiRR-5

6NiRR-25

6NiRR-100

6NiRR-500

6CoRR-5

6CoRR-25

6BCL-QHNi-C8

6BCL-QHNi-C5

6BCL-QHZn-C8

6BCL-QHZn-C5

6BCL-QHCo-C8

6BCL-QHCo-C5

6BCL-QLNi-C8

6BCL-QLNi-C5

6BCL-QLZn-C8

6BCL-QLZn-C5

6BCL-QLCu-C8

6BCL-QLCu-C5

6BCL-NTANi-25

6BCL-NTANi-100

6BCL-NTANi-500

6CoRR-100

6CoRR-500

6RRFNi-Ctg1-2

6RRFNi-Ctg1-5

AF6Ni-Ctg5-1

AF6Ni-Ctg5-5

His-COLUMN HIGH Density NICKEL 8 x 1 ml

HisXL-COLUMN HIGH Density NICKEL 5 x 5 ml

His-COLUMN HIGH Density ZINC 8 x 1 ml

HisXL-COLUMN HIGH Density ZINC 5 x 5 ml

His-COLUMN HIGH Density COBALT 8 x 1 ml

HisXL-COLUMN HIGH Density COBALT 5 x 5 ml

His-COLUMN LOW Density NICKEL 8 x 1 ml

HisXL-COLUMN LOW Density NICKEL 5 x 5 ml

His-COLUMN LOW Density ZINC 8 x 1 ml

HisXL-COLUMN LOW Density ZINC 5 x 5 ml

His-COLUMN LOW Density COPPER 8 x 1 ml

HisXL-COLUMN LOW Density COPPER 5 x 5 ml

HIGH PRESSURE: CHELATING RAPID RUN™ BEADS: PRE-PACKED CARTRIDGE

NICKEL RAPID RUN™ Cartridges 1ml

NICKEL Affinity Cartridges 5ml

2 x 1ml

5 x 1ml

1 x 5ml

5 x 5ml

GST PURIFICATION

6BCL-QH-25 25 ml

6BCL-QH-100 100 ml

6BCL-QH-500 500 ml

6BCL-QHNi-25 25 ml

6BCL-QHNi-100 100 ml

6BCL-QHNi-500 500 ml

6BCL-QHZn-25 25 ml

6BCL-QHZn-100 100 ml

6BCL-QHZn-500 500 ml

6BCL-QHCo-25 25 ml

6BCL-QHCo-100 100 ml

6BCL-QHCo-500 500 ml

6BCL-QL-25 25 ml

6BCL-QL-100 100 ml

6BCL-QL-500 500 ml

6BCL-QLNi-25 25 ml

6BCL-QLNi-100 100 ml

6BCL-QLNi-500 500 ml

6BCL-QLZn-25 25 ml

6BCL-QLZn-100 100 ml

6BCL-QLZn-500 500 ml

6BCL-QLCu-25 25 ml

6BCL-QLCu-100 100 ml

6BCL-QLCu-500 500 ml

LOW PRESSURE: PROTEIN A AGAROSE BEADS: BULK RESINS

PROTEIN A Agarose Resin

PA09-R5 5 ml

PA09-R25 25 ml

PA09-R500

LOW PRESSURE: PROTEIN A AGAROSE BEADS: PRE-PACKED COLUMN

PROTEIN A Agarose Column PA09-C1-1

PROTEIN A Agarose XL Column PA09-C5-1

PROTEIN A Test Kit PA09-K-01

LOW PRESSURE: PROTEIN L AGAROSE BEADS: BULK RESINS

PROTEIN L Agarose Resin

PROTEIN L Test Kit

500 ml

1 x 1 ml

1 x 5 ml

1 X 100 µl

HIGH PRESSURE: PROTEIN A RAPID RUN BEADS: PRE-PACKED CARTRIDGE

TMPROTEIN A Rapid Run Cartridges

TMHIGH PRESSURE: AFFI-MAB BEADS: BULK RESINS

TMAFFI-MAB Fine Agarose Resin

TMAFFI-MAB Fine Test Kit

TMHIGH PRESSURE: PROTEIN G RAPID RUN BEADS: BULK RESINS

PROTEIN G Agarose Resin 4 RAPID RUN™

PROTEIN G Test Kit

4BCLPL-R2 2 ml

4BCLPL-R5 5 ml

4BCLPL-R10 10 ml

4BCLPL-K-01 1 X 100 µl

6RRFPA-Ctg1-2 2 x 1 ml

6RRFPA-Ctg1-5 5 x 1 ml

MABRRF-R10 10 ml

MABRRF-R25 25 ml

MABRRF-R100 100 ml

MABRRF-R200 200 ml

MABRRF-K-01 1 X 100 µl

4RRPG-1 1 ml

4RRPG-5 5 ml

4RRPG-25 25 ml

4RRPG-K-01 1 X 100 µl

GLUTATHIONE Agarose Beads4B-GLU-10 10 ml

4B-GLU-100 100 ml

LOW PRESSURE: GLUTATHIONE AGAROSE BEADS: BULK RESINS

Compatible

withTM TMAKTA & FPLC

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 14: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

PRODUCT NAME CAT. NO. PACK SIZE

Quality & Purity of Biotherapeutics®

PRODUCT NAME CAT. NO. PACK SIZE PRODUCT NAME CAT. NO. PACK SIZE

SIZE EXCLUSION CHROMATOGRAPHY

ACCESSORIES

EMPTY COLUMNS & EMPTY CARTRIDGES

PLASTIC MINI COLUMNS MC-100 100

EMPTY SPIN COLUMNS

PLASTIC SPIN COLUMNS SP-25 25

EMPTY COLUMNS

PLASTIC SMALL COLUMNS CS-20 20

PLASTIC COLUMNS C-50 50

PLASTIC XL COLUMNS CXL-50 50

EMPTY CARTRIDGES

EMPTY CARTRIDGES (1ml) EB-Ctg1-5 5

CARTRIDGES ACCESSORIES

STOP PLUG SEB-10 10

SYRINGE CONNECTOR SCEB-1 1

EMPTY FPLC COLUMNS

EMPTY FPLC 8 ml Columns FPLC8-3 3

EMPTY FPLC 30 ml Columns FPLC30-2 2

EMPTY FPLC 45 ml Columns FPLC45-2 2

EMPTY FPLC 80 ml Columns FPLC80-1 1

FPLC Luer lock-male FPLCLM-1 1

FPLC Luer lock-female FPLCLF-1 1

VERY LOW Density AMINOETHYL 4 RAPID RUN™

HIGH Density AMINOETHYL 4 RAPID RUN™

LOW Density AMINOETHYL 6 RAPID RUN™

HIGH Density AMINOETHYL 6 RAPID RUN™

VERY LOW Density AMINOETHYL 6 RAPID RUN™ FINE

ELECTROPHORESIS

AGAROSE POWDER

ABT Agarose LE

ABT Agarose HR

ABT Agarose GA

ABT Agarose LM

EMPTY MINI COLUMNS

4RR-AVL4-25 25 ml

4RR-AVL4-100 100 ml

4RR-AH1-25 25 ml

4RR-AH1-100 100 ml

6RR-AL0-25 25 ml

6RR-AL0-100 100 ml

6RR-AM3-25 25 ml

6RR-AM3-100 100 ml

6RRF-AVL4-25 25 ml

6RRF-AVL4-100 100 ml

A-1270-100 100 g

A-1270-500 500 g

A-1280-100 100 g

A-1280-500 500 g

A-1290-100 100 g

A-1290-500 500 g

A-1300-25 25 g

A-1300-100 100 g

HIGH PRESSURE: AMINOETHYL RAPID RUN™ BEADS: BULK RESINS

AGAROSES

EMPTY FPLC COLUMNS SUPPLIES

AFFINITY COUPLING

AMINO GROUPS

LOW Density GLYOXAL 4BCL

HIGH Density GLYOXAL 4BCL

LOW Density GLYOXAL 6BCL

HIGH Density GLYOXAL 6BCL

VERY HIGH Density GLYOXAL 6BCL

GLYOXAL KIT GLYOXK-2

LOW Density GLYOXAL 4 RAPID RUN™

HIGH Density GLYOXAL4 RAPID RUN™

LOW Density GLYOXAL4 RAPID RUN™ FINE

LOW Density GLYOXAL6 RAPID RUN™

HIGH Density GLYOXAL6 RAPID RUN™

LOW Density GLYOXAL6 RAPID RUN™ FINE

VERY LOW Density AMINOETHYL 4BCL

HIGH Density AMINOETHYL 4BCL

LOW Density AMINOETHYL 6BCL

HIGH Density AMINOETHYL 6BCL

AMINOETHYL LOW KIT AMINOL-2

AMINOETHYL COMPLETE KIT AMINOC-2

6% BCL Agarose Bead FINE (20-50µm)

4% RAPID RUN™ Agarose Bead STANDARD (50-150µm)

6% RAPID RUN™ Agarose Bead STANDARD (50-150µm)

A-1061F-250 250 ml

A-1061F-500 500 ml

A-1061F-1000 1 l

4RRS-500 500 ml

4RRS-1000 1 l

4RRS-10000 10 l

6RRS-500 500 ml

6RRS-1000 1 l

6RRS-10000 10 l

4BCL-GL0-25

4BCL-GL0-100

4BCL-GH1-25

4BCL-GH1-100

6BCL-GL0-25

6BCL-GL0-100

6BCL-GM3-25

6BCL-GM3-100

6BCL-GH1-25

6BCL-GH1-100

25 ml

100 ml

25 ml

100 ml

25 ml

100 ml

25 ml

100 ml

25 ml

100 ml

4RR-GL0-25 25 ml

4RR-GL0-100 100 ml

4RR-GH1-25 25 ml

4RR-GH1-100 100 ml

4RRF-GL0-25 25 ml

4RRF-GL0-100 100 ml

4RR-GL0-25 25 ml

4RR-GL0-100 100 ml

4RR-GM3-25 25 ml

4RR-GM3-100 100 ml

4RRF-GL0-25 25 ml

4RRF-GL0-100 100 ml

4BCL-AVL4-25 25 ml

4BCL-AVL4-100 100 ml

4BCL-AH1-25 25 ml

4BCL-AH1-100 100 ml

6BCL-AL0-25 25 ml

6BCL-AL0-100 100 ml

6BCL-AM3-25 25 ml

6BCL-AM3-100 100 ml

HIGH PRESSURE: RAPID RUN™ AGAROSE BEADS

LOW PRESSURE: GLYOXAL AGAROSE BEADS: BULK RESINS

HIGH PRESSURE: GLYOXAL RAPID RUN™ BEADS: BULK RESINS

ACIDIC GROUPS

LOW PRESSURE: AMINOETHYL AGAROSE BEADS : BULK RESINS

2% BCL Agarose Bead STANDARD (50-150µm)

4% BCL Agarose Bead STANDARD (50-150µm)

6% BCL Agarose Bead STANDARD (50-150µm)

8% BCL Agarose Bead STANDARD (50-150µm)

10% BCL Agarose Bead STANDARD (50-150µm)

4% BCL Agarose Bead MACRO(1) (150-350µm)

6% BCL Agarose Bead MACRO(1)

(150-350µm)

10% BCL Agarose Bead MACRO(1) (150-350µm)

4% BCL Agarose Bead FINE (20-50µm)

A-1021S-500 500 ml

A-1021S-1000 1 l

A-1021S-10000 10 l

A-1041S-500 500 ml

A-1041S-1000 1 l

A-1041S-10000 10 l

A-1061S-500 500 ml

A-1061S-1000 1 l

A-1061S-10000 10 l

A-1081S-500 500 ml

A-1081S-1000 1 l

A-1081S-10000 10 l

A-1101S-500 500 ml

A-1101S-1000 1 l

A-1101S-10000 10 l

A-1041M-500 500 ml

A-1041M-1000 1 l

A-1061M-500 500 ml

A-1061M-1000 1 l

A-1101M-500 500 ml

A-1101M-1000 1 l

A-1041F-250 250 ml

A-1041F-500 500 ml

A-1041F-1000 1 l

2% B Agarose Bead STANDARD (50-150µm)

4% B Agarose Bead STANDARD (50-150µm)

6% B Agarose Bead STANDARD (50-150µm)

8% B Agarose Bead STANDARD (50-150µm)

10% B Agarose Bead STANDARD (50-150µm)

(1) 4% B Agarose Bead MACRO(150-350µm)

(1) 6% B Agarose Bead MACRO(150-350µm)

(1)10% B Agarose Bead MACRO (150-350µm)

4% B Agarose Bead FINE (20-50µm)

6% B Agarose Bead FINE (20-50µm)

A-1020S-500

A-1020S-1000

A-1020S-10000

500 ml

1 l

10 l

A-1040S-500 500 ml

A-1040S-1000 1 l

A-1040S-10000 10 l

A-1060S-500 500 ml

A-1060S-1000 1 l

A-1060S-10000 10 l

A-1080S-500 500 ml

A-1080S-1000 1 l

A-1080S-10000 10 l

A-1100S-500 500 ml

A-1100S-1000 1 l

A-1100S-10000 10 l

A-1040M-500 500 ml

A-1040M-1000 1 l

A-1060M-500 500 ml

A-1060M-1000 1 l

A-1100M-500 500 ml

A-1100M-1000 1 l

A-1040F-250 250 ml

A-1040F-500 500 ml

A-1040F-1000 1 l

A-1060F-250 250 ml

A-1060F-500 500 ml

A-1060F-1000 1 l

LOW PRESSURE: PLAIN AGAROSE BEADS

LOW PRESSURE: CROSSLINKED AGAROSE BEADS

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 15: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Quality & Purity of Biotherapeutics ®

Ready to use HPLC lectin Columns

AffiSep® HPLC lectin columns are designed for the analysis, separation and purification of glycoproteins and other glycoconjugates containing lectin-specific carbohydrate residues. The columns are ready-to-use for operation with common HPLC or FPLC equipments and facilitate lectin affinity seperations of glycoproteins in a simple way for fast and reproducible results.

AffiSep® HPLC lectin columns specifications

CAT. NO. PRODUCT DESCRIPTION LECTIN

COVALENTLYIMMOBILIZED LECTIN(mg/ml ADSORBENT)

AMOUNT OF BOUNDGLYCOPROTEIN

(ug/0.6 ml ADSORBENT)SIZE

011031011032011033011034

011041011042011043011044

011051011052011053011054

011061011062011063011064

011071011072011073 011074

011082

011091 011092011093

011121011122011123011124

011131011132011133011134

AffiSep® WGA column

AffiSep® ConA column

AffiSep® LCH column

AffiSep® PNA column

AffiSep® AIL column

AffiSep® VVL column

AffiSep® AAL column

AffiSep® SNA column

AffiSep® MAL column

Triticumvulgaris

Canavaliaensiformis

Lensculinaris

Arachishypogaea

Artocarpusintegrifolia

Hairy vetch

Aleuriaaurantia

Sambucusnigra

Maackiaamurensis

~6

~15

~3

~3

~3

~3

~3

~3

~3

≥ 100

≥ 150

≥ 135

≥ 125

≥ 215

-

-

≥ 50

≥ 125

0.8 mL1.6 mL2.5 mL4.0 mL

0.8 mL1.6 mL2.5 mL4.0 mL

0.8 mL1.6 mL2.5 mL4.0 mL

0.8 mL1.6 mL2.5 mL4.0 mL

0.8 mL1.6 mL2.5 mL 4.0 mL

1.6 mL

0.8 mL1.6 mL2.5 mL

0.8 mL1.6 mL2.5 mL4.0 mL

0.8 mL1.6 mL2.5 mL4.0 mL

• Pore diameter: 1000 Å• Mean diameter particles: 75 µm

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 16: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

CAT. NO. PRODUCT DESCRIPTION LECTIN

COVALENTLYIMMOBILIZED LECTIN(mg/ml ADSORBENT)

AMOUNT OF BOUNDGLYCOPROTEIN

(ug/0.6 ml ADSORBENT)SIZE

Storage:

• Lectin columns should be stored equilibrated in adsorption buffer containing sodium azide at 4 °C.

Handling of buffers and samples:

• All buffer solutions should be filtered through 0,2 µm.

• All samples should be solved in adsorption buffer and filtered through 0,2 µm.

Protocol for column handling:

• Equilibrate column for 30 min with adsorption buffer (flow: 0,8 mL/min)

• Inject prepared sample solution and wash the column with adsorption buffer

• Elute the sample for at least 4 min with the recommended lectin-specific elution buffer at 0,8 mL/min.

• Equilibrate with adsorption buffer for 60 minutes for regeneration.

Operational conditions for Lectin columns:

• Max. column backpressure: 100 PSI (7 bar)

• Recommended flow rate: 0,6 - 0,8 mL/min

• Max. flow rate: 1,2 mL/min

• Detection wavelength: 280 nm for glycoproteins, 300 nm for p-Nitrophenyl-carbohydrates

• Range of pH: AffiSep®HPLC lectin columns can be operated between pH 4.0 and pH 8.0

011141011142011143011144

011151011152011153011154

011161011162011163011164

AffiSep® UEA column

AffiSep® GNA column

AffiSep® ECL column

Ulexeuropaeus

Galanthusnivalis

Erythrinacristagalli

~3

~3

~5

0.8 mL1.6 mL2.5 mL4.0 mL

0.8 mL1.6 mL2.5 mL4.0 mL

0.8 mL1.6 mL2.5 mL4.0 mL

-

≥ 200

≥ 100

Quality & Purity of Biotherapeutics®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 17: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Ÿ

biopharmaceutical samples containing surfactants

Ÿ Demasking independent of masking time and endotoxin concentration

Ÿ All needed reagents for developing a formulation-specific protocol included in the kit

Ÿ Detailed technical guidelines provided

Full quantitative endotoxin recovery in

Specifications & Advantages

Endo-RS® (Demasking of Endotoxin)

Endotoxin Recovery Kits (Surfactant)

Endo-RS® Endotoxin Recovery Kit is a novel sample preparation kit enabling complete endotoxin recovery in biopharmaceutical drug formulations containing non-ionic surfactants such as Polysorbate 20, Polysorbate 80 or Octylphenol etho xylates.

Non-ionic surfactants are well known to cause Low Endotoxin Recovery (LER). Intensive studies of the phenomenon have shown that the physicochemical proper ties of surfactants render endotoxin molecules inaccessible (masked) for detection in such samples. The Endo-RS® Endotoxin Recovery Kit now provides the essential reagents and a detailed guideline for evaluating and establishing an optimized endo-toxin demasking protocol for each individual formulation containing surfactants.

Applying the Endo-RS® Endotoxin Recovery Kit prior to endotoxin detection with the EndoLISA® Endotoxin Detection Assay will ensure FDA compliant and accurate results in spike validation studies and routine quality control testing.

Endo-RS® Protocol:

1. Screening:- Selection of the agents suitable for the specific formulation

2. Optimization:- Adjustment of protocol

3. Detection:- Quantification of demasked (accessible) endotoxin with the EndoLISA® assay

Endo-RS® Endotoxin Recovery Kit 609065

PRODUCT NAME CAT. NO.

Toolbox for demasking endotoxin in biopharmaceuticalformulations containing surface active agents

Quality & Purity of Biotherapeutics ®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 18: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Endotoxin Detection Assays

EndoZyme® is a homogeneous fluorescence end-point assay for the quantitative determination of endotoxins (lipopolysaccharides). The assay is based on an improved recombinant Factor C (rFC), the endotoxin-specific principal receptor in the LAL enzyme cascade. With a dynamic range of 0-50 EU/ml and a sensitivity of 0.005 EU/ml, EndoZyme® offers state-of-the-art test performance.

EndoZyme® specifically detects endotoxin thereby overcoming the problem with false-positive results due to β-Glucans. EndoZyme® is particularly suited as endotoxin test for biopharmaceuticals, medical devices, water and environmental swabs.

EndoZyme® correlation with LAL-Assay

Specifications & Advantages

Standard curve of the EndoZyme® Assay; concent- rations of the LPS standard are plotted against the corresponding relative fluorescence signal. The log net fluorescence is proportional to the log endotoxin concentration and is linear in the 0.005-50 EU/ml range

EndoZyme® endotoxin detection standard curve

rFC Recommended as LAL alternative in EU & USPharmacopoeia (EP,5.1.10) & (USP33,NF28,6.30)

Better Alternativeto LAL Test

Correlation plot of EndoZyme® versus LAL assay where multiple LPS preparations and dilutions from different bacteria such as E. coli, Salmonella and Pseudomonas, including LPS of mutant strains, were compared. The endotoxin was determined quantitatively according to the manufacturer’s instructions and the results (EU/ml) were plotted against each other. This comparison shows that EndoZyme® correlates well with the commercially available LAL test, with a

2correlation coefficient (R ) of 0.9476.

EndoZyme® (Enhanced Recombinant Factor C)

Quality & Purity of Biotherapentics®

EndoZyme®- 192 tests 609050

PRODUCT NAME CAT. NO.

Ÿ

Ÿ Broad measurement range 0.005-50 EU/ml

Ÿ LPS-specific recombinant technology

Ÿ No false-positive ß-Glucan reaction

Ÿ Excellent reliability and lot-to-lot consistency

Ÿ All needed reagents included in the kit

Ÿ No animal material, therefore saving the diminishing horseshoe crab population

Highly sensitive endotoxin detection assay

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 19: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

EndoLISA® (ELISA Based)

EndoLISA® is a new method for determination of endotoxin (LPS) levels where high-affinity binding of endotoxin by LPS-specific phage protein is followed by endpoint fluorescence measurement.

The microtiter plate -based assay format is one of the major advantage of EndoLISA®, as a result of which potentially interfering substances such as organic solvents, chaotropic substances and detergents are removed by a washing step. This enables the EndoLISA® user to precisely determine the endotoxin level without matrix effects, without the need for dilution and with a very broad measurement range.

Standard curve of the EndoLISA® test; concentrations of the LPS standard are plotted against the relative fluorescence signal. EU, endotoxin unit.

EndoLISA® correlation with LAL-Assay

EndoLISA® endotoxin detection standard curve

Correlation plot of EndoLISA® versus LAL assay where multiple LPS preparations and dilutions from different bacteria such as E. coli, Salmonella and Pseudomonas, including LPS of mutant strains, were compared. The endotoxin was determined quantitatively according to the manufacturer’s instructions and the results (EU/ml) were plotted against each other. This comparison shows that EndoLISA® correlates well with the commercially available LAL -assay, with a correlation coefficient of 0.9078.

rFC Recommended as LAL alternative in EU & USPharmacopoeia (EP,5.1.10) & (USP33,NF28,6.30)

Better Alternativeto LAL Test Specifications & Advantages

Quality & Purity of Biotherapeutics ®

EndoLISA®- 192 tests 609033

PRODUCT NAME CAT. NO.

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Ÿ Overcomes limitations of existing methods, such as the need for extension dilution

Ÿ Reduced matrix effects due to integrated washing step

Ÿ Robust assay with excellent reproducibility

Ÿ Broad measurement range (0.05-500 EU/ml)

Ÿ Broad pH range (pH4 - pH9)

Ÿ Less interference at high salt conditions e.g. NaCl, GdnHCl

Ÿ All reagents necessary to run the assay included in the kit

Ÿ Saves the diminishing horseshoe crab population

Page 20: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

EndoTrap® (Affinity Chromotography Resins)

Endotoxin Removal Kits

EndoTrap® affinity chromatography for highly specific & efficient endotoxin (LPS) removal. The EndoTrap® ligand is a highly LPS-specific, completely non-toxic protein derived from bacteriophages. EndoTrap® removes endotoxins (lipopolysaccharides/LPS) from aqueous solutions of a wide range of samples such as proteins, antibodies, vaccines, nucleic acids, buffers and cell extracts with excellent sample recovery rates.

EndoTrap® can be used in column (gravity flow) or batch mode and is suitable for up-scaling on fully automated liquid-chromatographic systems.

EndoTrap ® red EndoTrap ® blue EndoTrap ® HD

LPS 2,000,000 EU/ml resin

3 times

4-9

Suitable for high salt

conditions conditions

(> 150 mM NaCl)

2,000,000 EU/ml

resin

3 times

6-9

Calcium chelators

> 5,000,000 EU/ml resin

More than 10 times

4-10

Suitable for high salt

(> 150 mM NaCl)

Binding capacity:

PH sample buffer:

Sample Applications

Suitable Buffers:

Reusability:

Proteins,

Peptides,

Antibodies

Proteins,

Peptides,

Antibodies,

DNA/RNA,

Antigens,

Plant extracts

Proteins,

Peptides,

Antibodies,

DNA/RNA,

Antigens,

Plant extracts,

Automated systems,

Biomanufacturing processes

*Measured values for BSA, MAK 33 (monoclonal antibody) and POD (peroxidase) with EndoTrap HD ®

Specifications & Advantages

Ÿ Best-in-class endotoxin binding capacity of 5,000,000 EU/ml

Ÿ Removes more than 99.99%* of LPS

Ÿ Excellent sample recovery rate > 95%*

Ÿ Non-toxic phage-derived ligand, no cytotoxic effects

Ÿ Re-use more than 10 times

Ÿ Available in large quantities for up-scaling in biopharmaceutical processes

Quality & Purity of Biotherapeutics®

Removal Rate>99.99%

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 21: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

CAT. NO.

321053, 321063321064, 321075321066

311053, 311063311064, 311075311066

800053, 800063

800033

800034, 800035800036, 800037

PRODUCT NAME DESCRIPTION

EndoTrap® red (1/1, 5/1, 10, 50, Bulk)*

Available as pre-filled columns and settles resin.

EndoTrap® HD (1/1, 5/1, 10, 50, 250, Bulk)*

Available as pre-filled columns and settles resin.

EndoTrap® Leakage ELISA (for blue)

EndoTrap® HD & EndoTrap®

EndoTrap® blue (1/1, 5/1, 10, 50, Bulk)*

Available as pre-filled columns and settles resin.

For use with e.g. PBS bufferedsamples

For use with e.g. HEPES, TRISMOPS, MES, PIPES bufferedsamples

For biotech/pharmaevaluation andproduction processes

12x8 well strips, 1 vial POD-Antibody1 vial Standard20 ml ABTS Substrate

*(1/1 = 1 x 1 ml column, 5/1 = 5 x 1 ml column, 10 = 10 ml resin etc.)

EndoGrade®

Endotoxin-free Reagents and Accessories

Microbiological contamination is a well recognized problem when research reagents are used in certain applications. In particular increased endotoxin levels often lead to artefacts and misinterpretations in cell culture or animal model experiments. With our EndoGrade® product range, we meet our customers demand for endotoxin-free reagents and accessories.

PRODUCT NAME PRODUCT

800050

607030

607100

607500

321000

321001

321002

EndoGrade Glass Test Tubes 112 units per pack

EndoGrade Water 30 ml 20 bottles per pack

EndoGrade Water 100 ml 16 bottles per pack

EndoGrade Water 500 ml 6 bottles per pack

EndoGrade Ovalbumin 10 mg

EndoGrade Ovalbumin 100 mg

EndoGrade Ovalbumin 1000 mg

Quality & Purity of Biotherapeutics ®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Page 22: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Automation- Lab Essentials®

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

3Trinity V - Industrial Microbiology System

3Trinity VAn optional colony counting module is available. This complete industrial microbiology system is often used in pharmaceutical QA/QC microbiology laboratories.

utilizes digital imaging to automate zone reading and calculations for antibiotic potency assays.

• Follows USP, EP, BP and JP agar diffusion assay methods

• 21 CFR Part 11 compliant

Ozone Sterilizer- unique PORTABLE laboratory sterilization system

Ÿ Sterilizes surfaces & air spaces in multiple areas & locations

Ÿ Reduction or elimination of Bacteria, Fungus, Viruses, Protozoa, Yeast & Algae

Ÿ No harmful liquids, chemicals, UV rays, or heat.

Ÿ Keeps equipment, tools, and work areas clean without chemical residue or damage

Ÿ Auto De-ozonation at 240 cfm at the end of a sterilization cycle

PRODUCT NAME CAT. NO.

Ozilla™ Ozone Sterilizer, 220V E400220

Antibiotic Potency Zone Reading

Colony Counting

• Automatically counts bacterial, yeast colonies and virus plaque assays on agar plates

• Saves 99% of reading time

3Trinity V

TMOzilla Ozone Sterlizer

Automate and standardize zone reading and calculations for antibiotic potency

ENCLOSURE TYPE

Tissue Culture Hood (3 feet wide)

Tissue Culture Hood (4 feet wide)

Tissue Culture Hood (5-6 feet wide)

Room

MIN. STERILIZATION TIME

4.5 hours

6 hours

8 hours

12 hours

Incubator 2 hours

Applications

*The Ozilla sterilizer is designed for use in sealed cabinets or rooms, and is not to be used in open spaces where people and animals are present

Ÿ

Ÿ IQ/OQ/PQ validation documents

Ÿ 21 inch touch screen

Instant digital reading & calculations

Page 23: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Vial Filling System

10uL to 5mL dispense range

• Reliable, precise, an accurate dispensing

• Up to 8 different solutions simultaneously

• Compact and stand alone design

• Easy XY programming

• Flexible configuration

Protégé Vial Filling System

Phone : +91-11-4875-4875 Email : [email protected] Fax : +91-11-2561-2008

Automation- Liquid Handling ®

HTS WASHING HTS COATING & WASHING

• Expandable to >1,000 plates/hour

• 350 plates/hour@100uL dispense with <2% CV

• 96 & 384 well plates & vial filling capable

• 8 independent channelswashing & filling in one pass

• Stand-alone wash & aspiration unit

• Operating programs are self-contained – no external computer required

• Dual function– Micro-plate

HTS DISPENSING

TriFLEX Microplate Coating& Washing System

300-96WW Dual MicroplateWashing System

300 DMC Microplate DispensingSystem

Stand-alone wash and aspiration unit

• Up to 6 wash cycles (fill and aspirate) per pass

• Coaxial wash/aspirate manifold provides fast dispensing & thorough aspiration

Page 24: Bioanalytical & Bioprocess - Biogeniux · 2015. 9. 1. · detection of natural and recombinant Protein A constructs with up to 100% recovery. ŸDetects 1ppm of Protein A residuals

Biogenuix Medsystems Pvt. Ltd.

412-B, Jyoti Shikhar Building, District Center,Janakpuri,

New Delhi-110058, INDIA

Phone : +91-11-4875-4875 • Fax : +91-11-2561-2008

E-mail : [email protected] • Web : www.biogenuix.com

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