Contract Formulation Development, Manufacturing &

Analytical ServicesCompliant with

cGMP, GLP, ISO 13485 and ISO 9001

Business Profile•Outsourcing company providing fully integrated one-stop-shop contract drug development and manufacturing services

•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

GMP Certification from Israel Institute for Standardization and Control of Pharmaceuticals, Israel Ministry of Health

GMP certificate for: • Contract manufacturing of IMP

• Contract QC & analytical testing

Departments

• Chemistry Lab• Formulation Lab • Analytical/QC Labs• GMP Plant• QA/RA

Spectrum of Services

Formulation development

QA/QC services

Method development & Validation

Bioanalytical ServicesRaw material testing

& releaseGMP Production

Custom chemical synthesis

Packaging for clinical trials

Custom chemical synthesis

•Active pharmaceutical ingredients (API)

•Intermediates

•Impurities

•Metabolites

•Reference standards

Formulation Services•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

• 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

Certified Manufacturer of:

Raviten injectable solution

Ravimig tablets

Lyophilized formulation of peptide with increased stability and safety

Formulation development and GMP manufacturing of freezed-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 released gel formulation to provide a sub-dermal depot for local anesthetics

Successful case studies of formulated products

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: 570

• No. of current customers: 120

• 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 assist you with your chemparma

needs

Web: www.nextar.co.ilSales/Projects: hagitb@nextar.co.il CEO: regina@nextar.co.ilPhone: +972-73-2244410