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Nextar presentation
- 1. Contract Formulation Development, Manufacturing & Analytical Services Compliant with cGMP, GLP, ISO 13485 and ISO 9001
- 2. 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 m 2 state-of-the-art labs and clean rooms cGMP, GLP & ISO 13485 internationally recognized certifications from regulatory agencies
- 3. 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
- 4. Departments Chemistry Lab Formulation Lab Analytical/QC Labs GMP Plant QA/RA
- 5. 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
- 6. Custom chemical synthesis Active pharmaceutical ingredients (API) Intermediates Impurities Metabolites Reference standards
- 7. 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
- 8. 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
- 9. 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
- 10. 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
- 11. 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
- 12. 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
- 13. Certified Manufacturer of : Raviten injectable solution Ravimig tablets
- 14. 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
- 15. 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
- 16. 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
- 17. 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
- 18. Our team
- 19. We will be happy to assist you with your chemparma needs Web: www.nextar.co.il Sales/Projects: hagitb@nextar.co.il CEO: [email_address] Phone: +972-73-2244410