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0 Senn Chemicals your CDMO for SWISS quality peptides and amino acid derivatives

for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

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Page 1: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

0

Senn Chemicals –

your CDMO

for SWISS quality

peptides and amino

acid derivatives

Page 2: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

1

Inhalt

2

4

7

About

Technology

1 MilestonesPharma and

cosmetic

Industries

Services

5

3

Facts

and Figures

History6

4

Page 3: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Why Senn Chemicals?

Page 4: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

3

Dr. Daniel Müller

CEO

Senn Chemicals AG was founded in 1963,

is family-owned and based in Switzerland.

We are cGMP and ISO certified, and

specialized in the production of peptides

and amino acid derivatives.

As a contract manufacturer we provide

individual solutions starting from small

scale for R&D to commercial API production.

About

Page 5: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

History of Senn

Founded in his garage in Dielsdorf

(1963).

What began as a catalog business

for carbohydrates and rare sugars

evolved into a global custom

peptides manufacturer serving

pharmaceutical, biotechnology and

cosmetic companies worldwide.

Guido A. Sennin 1963

4

The early days

Page 6: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Facts & FiguresFacts

Pharma-

ceutical

biotech and

cosmetic

industries

globally

Deep

know-how

in:

Switzerland

85 1963

Employees

Founded in

Dedicated

manufacturing

in

5

Deep know-how

in high quality

amino acid

derivatives

and peptides –

since 1963

approved

inspected

certifiedMay 2016 (GMP)

March 2014 (GMP)

July 2010 (PAI)

November 2002 (GMP)

August 2018

August 2016

August 2014

August 2012

Page 7: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Milestones

1963Founded in

1 2

34

5

6

7 8

amino acid

building block

synthesis

Pioneered

Boc, Z

APIs

Fmoc,

Boc, Z protected amino

acid derivatives

2’500 l

Specialized

in solution phase

synthesis up to

Growing

in solid phase

technology incl.

prep. HPLC and

lyophilisation

PeptidesFragments

macrocycles

complex 40+ mer

linear/convergent

strategies

GMP

APIs

Manufacturer of

high

potent

APIs

Next step:

Manufacturer of

6Milestones

4

Page 8: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

7

To us, you are not a project and you’re not only

a client. You are our strategic partner.

Your success.

Dedicated Project Manager to our clients

Single point of contact and center of communication

Progress reporting

Knowledge of project details

Supervision from the evaluation to the final completion of deliverables

Page 9: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Services8

Anita Jost

Finance / CFO

Kathleen Noack

VP Sales & Marketing

Dr.Thomas Hellmann

FvP / Quality Unit

Dr. Florence Bérézovsky

Material Management

Dr. Markus Löweneck

Research & Development

Dr. Daniel Müller

Chief Executive Officer

Dr. Wenqing Hu

Site Manager GP

Dr. Daniel Müller

Chief Executive Officer

SHE

• (1)

Human Resources

• Xenia Sabrina Esenwein

• (1)

ICT

• Benjamin Andreas

• (1)

• (1 hiring)

Accounting

• (1)

Key Account Manager

• (3)

Business Development

• (1)

Customer Service

• (1)

Quality Assurance

• Dr. Tünde Vig Slenters

• (8)

Quality Control

• André Wey

• (13)

Purchasing

• Iris Lang

• (1)

Logistics

• (2)

House Keeping

• (2)

Laboratory

• (4)

Pilot & Upscaling

• Dr. Mirsad Selimovic

• (7)

Project Manager

• (2)

Production

• Harald Vökt

• (19)

Engineering

• (2)

Maintenance

• Christian Spühler

• (5)

Our Team

Page 10: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Our Products –

at Senn Chemicals

Services

Peptides for pharmaceutical

and cosmetic industry

Peptidomimetics

Lipopeptides

Glycopeptides

Peptide Polymers

Amino Acid Derivatives

Carbohydrates

Small Molecules

Nucleotides

Excipients

Resins

9

1

2

3

Peptide APIs

cGMP

FDA inspected

Solid Phase Synthesis

Solution Phase Synthesis

Page 11: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

10

A good working environment

is for me an essential

element to ensure we

provide products of ...

Amelie Moya

Rodriguez

Staff member

production

high quality

Services

Page 12: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

11

Our Services –Services

Page 13: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

12

Services / Process Development

Solid Phase ChemistryAutomated SPPS Reactors

CSBio (80/160 L, operated in GP site)

PTI Prelude

PTI Tribute

Activotec P11

Semi-automated SPPS Reactors (variable scales)

Lab Lyophilizer (Zirbus Technology, VaCo5)

Solution Phase ChemistryHydrogenators (0.1 L, 2 L, 20 L)

Low Temperature Reactor (20 L) down to minus 120 °C

Glass Reactors, jacketed (3 L, 6 L, 10 L, 20 L, 30 L)

3 Automated Laboratory Reactors (FlexyCUBE, Systag)

Purification EquipmentPreparative HPLC

Semi-preparative HPLC (AlphaCrom)

HPLC-Skid (3L/ min) (AlphaCrom) with 10 cm ID or 20 cm ID DAC column

Preparative MPLC

Automated Purification System (Teledyne Isco)

Page 14: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

13

Services / Process Development

Modde 11 ProSoftware for advanced DOE and quality

analysis for development and manufacturing

DynochemProcess development and scale-up software

BritestTools to define, structure and translate working

knowledge into process understanding

Page 15: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Technology –Technology

Multi-Purpose Glass-Line Reactors • 250 to 2’500 L

• - 20 to +120 °C

Hydrogenation Reactors • 630 to 2’500 L

• Max. 6 bar

Solid Phase Reactors • 80 to 160 L

Preparative HPLC Chromatography

cGMP Suites

Lyophilization

14

From early

research to

commercial

phase

Page 16: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

15

Multi-Purpose Reactors • 100 to 2’500 L

• - 20 to +120 °C

• glass-lined, enamelled, Hastelloy, steel

Hydrogenation Reactors • 100 to 2’500 L

• Max. 6 bar

Filtration • Nutsche filters (various sizes)

• Pressure filters

Drying• Vacuum tray driers (various sizes)

Solid Phase Reactors • 80 to 160 L

Preparative HPLC Chromatography• Production Skid (3 L/min)

• 10 cm ID DAC column

• 20 cm ID DAC column

Page 17: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

18SENN Quality Control to achieve

project goals:

Method Development

Method Qualification and Validation

Stability Studies

Qualified External Service Laboratories

Reference Standard Qualification

State of the art technologies in

Quality Control:

Physical Characterization

Impurity Identification

Residual Solvent Determination

Pharmacopeia Testing

Chromatographic Assays

Spectrometry

LC-MS

LC-MS/MS

HPLC

GC

Qualified contract laboratories used for any additional

analytics in agreement with the customer.

Quality Unit &

Expertise

Quality Control

Service

Quality Unit &

Expertise

Quality Control

Technologies

Page 18: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

17Top

Swiss

quality

Acylation

Alkylation

Amidation

Amination

Aminoalkylation

Carboxylation

Condensation

Amide Coupling

Cyclization

Enzyme catalyzed reactions

Epoxidation

Esterification

Glycosylation

Grignard

Halogenation

Hydrogenation

Oxidation

Polymerization

Transesterification

Page 19: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

19Technology

MgBr

R3

R2

N

R1

O

R3

NN

R1

O

R2

O

+THF

R2

R1

O

O

R2

R1

O

"O"

solvent

R2 OH

O

R1

R2 O

O

R1

acid

solvent

Grignard-Reactions

50-100 kg scale

Epoxidation-Reactions

50 kg scale

Tert-Butylation-Reactions

25-50 kg scale

Stereoselective Reductions

20 kg scale

OH

NH3

+Cl

O

NH3

+Cl

R1

R1

H2 / catalyst

MeOH

Portfolio

of developed

Products

Page 20: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

20

Technology

Portfolio

of developed

Products

Reductive aminations

+200 kg scale

Complex synthetic

processes1 kg scale

O

O

NH

R1

MeOH

O

O

NH2

R1

CH3

O

H

HCl

H2

+

HCl

NH

COOR2

NH(Boc)

R1

NH

COOR2

NH

R1

I) RuO2*H2O/ NaBrO3

II) NaBH4

III) PPh3, I2IV) H2NtBu

Si

O

R1

O O

OR23 step synthesis

(reduction, alkylation, protection, ...)

R3

R2

NH

O

OR4

O

R1

Si

5 step synthesis(reduction, alkylation, hydrogenolysis, ...)

Page 21: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Critical Raw Materials

Regulatory Starting Materials

Intermediates

APIs

Excipients

21

Serving the

pharmaceutical

industry

Page 22: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

21

Our Services for pharmaceutical

industry

From early research to commercial phases

Service according to all Preclinical and clinical phases

For intermediates and APIs

Fragments and Peptides

Project specific requirements upon final requirements and application

Research Preclinical Phase 1 Phase 2 Phase 3 Commercial

Process Optimization, Scale-Up, Validation, Commercial SupplyEarly Development,…

Page 23: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Peptide APIs – at Senn ChemicalsPharmaceutical Industry

22

Excellent safety &

tolerability

High efficacy

Synthetic flexibility

High target affinity &

selectivity

Predictable

metabolism

Inspired by nature or

rational design

Established

manufacturing know-how

Features

Page 24: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Peptide APIs – applicationsPharmaceutical Industry

23

Obesity

Diabetes

Further Applications

Prostate

cancer

Breast cancer

Uterine fibroids

Chronic kidney

disease

Porphyria

Personalized medicine Analgesia

Neurodegenerative

diseases

Applications

Metabolic diseases

Gastroenterology

Irritable bowel

syndrome

Short bowel

syndrome

Oncology

Page 25: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Cosmetic Peptides – at Senn ChemicalsCosmetic Industry

Peptides have become the most innovative

and vital ingredients for the cosmetic

industry. Peptides are utilized as active

ingredients in cosmetic products due to their

unique properties:

24

Page 26: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Cosmetic Peptides –Cosmetic Industry

Cosmetic

peptide

from R&D to

commercial

scale

• Stimulate wound healing

• Improve elasticity and firmness of aged skin

• Reduce the deepness of wrinkles

• Reduce fine lines

• Provide anti-inflammatory activity

• Enhance collagen synthesis

• Stimulate endothelial cell proliferation and

angiogenesis

• Affect skin pigmentation

(lightening or tanning of skin can be enhanced)

25

Page 27: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Create your own innovative peptide –

Solutions Synthesized

Cosmetic Industry26

Page 28: for SWISS quality peptides and amino acid derivatives Chemical… · Peptide Polymers Amino Acid Derivatives Carbohydrates Small Molecules Nucleotides Excipients Resins 9 1 2 3 Peptide

Senn – your partner in peptide chemistry

ISS

Industriestrasse 12Management, QA/QC, Logistics

GP

Guido Senn-Strasse 1cGMP manufacturing

RW

Ruchwiesenstrasse 6R&D, Lab-Scale and Pilot Plant