Nextar ChemPharma Solutions Ltd :

Accelerating your drug to first-in-humans

Nextar ChemPharma Solutions Ltd :

Accelerating your drug to first-in-humans

Contract Formulation Development, Manufacturing &

Analytical Services

Compliant with cGMP, GLP, ISO 13485 and ISO 9001

www.nextar.co.il

Business Profile

•Outsourcing company providing fully integrated one-stop-shop contract drug development and manufacturing partner

•Located at the Weizmann Science Park,the heart of Israel's life science industry

•35 experienced high-skilled professional employees

•Over 1400 m2 state-of-the-art labs and clean rooms

•cGMP, GLP & ISO 13485 internationally recognized certifications from regulatory agencies

Departments

• Chemistry Lab

• Formulation Lab

• Analytical/QC Labs

• GMP Plant

• QA/RA

Spectrum of Services

Formulation development

QA/QC services

Method development & Validation

Bioanalytical Services

Raw material testing & release

GMP Production

Custom chemical synthesis

Packaging for clinical trials

Custom chemical synthesis

• Active pharmaceutical ingredients (API)

• Synthesis of new analogs to strengthen your patent portfolio

• Intermediates

• Impurities

• Metabolites

• Reference standards

Custom chemical synthesis

• Active pharmaceutical ingredients (API)

• Synthesis of new analogs to strengthen your patent portfolio

• Intermediates

• Impurities

• Metabolites

• Reference standards

Formulation Services – Finding innovative solutions for your drug candidate

•Formulation development of injectables, topical creams, ophthalmic solutions, suspensions, emulsions, capsules, tablets, foams

•Reformulation, repositioning, repurposing of generic drugs

•Formulation development of innovative NCE, cytotoxics and biologicals

•Improvement of solubility and bioavailability

•Taste masking of bitter drugs

•Preparation of formulations for preclinical efficacy/toxicity studies

Systematic approach to develop the most appropriate formulation through:• Ionization of functional groups and salt

formation

• Drug complexation with cyclodextrins

• Formation of stacking complexes to increase drug solubility

• Drug dissolution in water-miscible cosolvent systems

• Micellation by non-ionic-surfactants

• Self-emulsifying drug delivery systems

• Nanoencapsulation in lipid-based drug delivery systems (liposomes, oil-in-water emulsions)

• Formulation of peptides and proteins using pharmaceutically acceptable solubilizing excipients

• Development and validation of analytical and bio-analytical methods

• Full range of stability tests and monitoring according to ICH

guidelines

• Forced degradation studies

• Analysis and profiling impurities

• Dissolution and drug release profiling

• Determination of leachables and extractables

• Bioanalysis of drug levels for PK studies

Analytical Services : Speeding up your R&D process

• GMP plant approved by Israel Ministry of Health & EU (PIC/s)

• Clinical trial material (CTM) manufacturing for US and EU clinical trials according to FDA and EMA standards

• CTM production for Phase I, II, III studies

• Full CTM formulation, manufacturing, packaging and release testing

• IND and IMPD support documentation (CMC)

• Full quality support for all clinical materials

Contract manufacturing & packaging

GMP certified manufacturing plant

• Manufacturing of all types of dosage forms: parenteral solutions, lyophilized sterile products, ophthalmic drops, suspensions, emulsions, topical creams, capsules and tablets

• Clinical supplies and testing of cytotoxics and scheduled drugs

GMP certified manufacturing plant

• Sterile manufacturing of injectables and lyophilized powders in Class 100 (ISO 5) clean rooms

• Validation of aseptic filling into vials, syringes or dropper bottles

• Lyophilized peptide formulation with increased stability and safety

• Formulation development and GMP manufacturing of freeze-dried vaccine formulation with a very limited amount of API

• Repositioning of a generic drug as a slow release tablet formulation with improved pharmacokinetic profile for new indication

• Formulation of water-insoluble anticancer drug with maximal bioavailability

• Process development, upscaling and GMP manufacturing of sterile implantable protein gel for cartilage regeneration

• Formulation optimization and GMP clinical supply in prefilled syringes of a phospholipid-based sustained release gel formulation to provide a sub-dermal depot for local anesthetics

Successful case studies at reduced costs and timelines

• Development of analytical methods for stability and release of new transdermal patch

• Compatibility and stability studies for two different new insulin pumps

• Development of analytical assays for washing solutions of a stent for coronary vessels

• Development of analytical methods and testing of cleansing solution for wound treatment

Nextar’s GLP studies contribute to registration of new combined medical devices

Achievements

• No. of projects performed: 650

• No. of current customers: 150

• Over 50 innovative formulations developed

• Process development, upscaling & manufacturing of over 25 products for clinical trials

Our Advantages• High-quality, cost effective, reliable and

integrated chempharma solutions, for a full range of pharmaceutical and analytical services

• Complies with international trend for outsourcing

• One-stop-shop with GLP/GMP certifications

• Formulation and manufacturing services optimized to accelerate your drug candidate to early clinical stage

• Regulatory advice through drug development process

• Significant saving of time and money

• Flexibility and transparency

Our team

We will be happy to contribute to your drug development by facilitating your journey to clinical

trials

www.nextar.co.il