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Nextar presentation

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  • 1. Contract Formulation Development, Manufacturing & Analytical Services Compliant with cGMP, GLP, ISO 13485 and ISO 9001
  • 2. <ul><li>Business Profile </li></ul><ul><li>Outsourcing company providing fully integrated one-stop-shop contract drug development and manufacturing services </li></ul><ul><li>Located at the Weizmann Science Park, the heart of Israel's life science industry </li></ul><ul><li>35 experienced high-skilled professional employees </li></ul><ul><li>Over 1400 m 2 state-of-the-art labs and clean rooms </li></ul><ul><li>cGMP, GLP & ISO 13485 internationally recognized certifications from regulatory agencies </li></ul>
  • 3. GMP Certification from Israel Institute for Standardization and Control of Pharmaceuticals, Israel Ministry of Health <ul><li>GMP certificate for: </li></ul><ul><li>Contract manufacturing of IMP </li></ul><ul><li>Contract QC & analytical testing </li></ul>
  • 4. Departments <ul><ul><li>Chemistry Lab </li></ul></ul><ul><ul><li>Formulation Lab </li></ul></ul><ul><ul><li>Analytical/QC Labs </li></ul></ul><ul><ul><li>GMP Plant </li></ul></ul><ul><ul><li>QA/RA </li></ul></ul>
  • 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. <ul><li>Custom chemical synthesis </li></ul><ul><li>Active pharmaceutical ingredients (API) </li></ul><ul><li>Intermediates </li></ul><ul><li>Impurities </li></ul><ul><li>Metabolites </li></ul><ul><li>Reference standards </li></ul>
  • 7. <ul><li>Formulation Services </li></ul><ul><li>Formulation development of injectables, topical creams, ophthalmic solutions, suspensions, emulsions, capsules, tablets, foams </li></ul><ul><li>Reformulation, repositioning, repurposing of generic drugs </li></ul><ul><li>Formulation development of innovative NCE, cytotoxics and biologicals </li></ul><ul><li>Improvement of solubility and bioavailability </li></ul><ul><li>Taste masking of bitter drugs </li></ul><ul><li>Preparation of formulations for preclinical efficacy/toxicity studies </li></ul>
  • 8. <ul><li>Systematic approach to develop the most appropriate formulation through: </li></ul><ul><li>Ionization of functional groups and salt formation </li></ul><ul><li>Drug complexation with cyclodextrins </li></ul><ul><li>Formation of stacking complexes to increase drug solubility </li></ul><ul><li>Drug dissolution in water-miscible cosolvent systems </li></ul><ul><li>Micellation by non-ionic-surfactants </li></ul><ul><li>Self-emulsifying drug delivery systems </li></ul><ul><li>Nanoencapsulation in lipid-based drug delivery systems (liposomes, oil-in-water emulsions) </li></ul><ul><li>Formulation of peptides and proteins using pharmaceutically acceptable solubilizing excipients </li></ul>
  • 9. <ul><li>Development and validation of analytical and bio-analytical methods </li></ul><ul><li>Full range of stability tests and </li></ul><ul><li>monitoring according to ICH guidelines </li></ul><ul><li>Forced degradation studies </li></ul><ul><li>Analysis and profiling impurities </li></ul><ul><li>Dissolution and drug release profiling </li></ul><ul><li>Determination of leachables and extractables </li></ul><ul><li>Bioanalysis of drug levels for PK studies </li></ul>Analytical Services
  • 10. <ul><li>GMP plant approved by Israel Ministry of Health & EU (PIC/s) </li></ul><ul><li>Clinical trial material (CTM) manufacturing for US and EU clinical trials according to FDA and EMA standards </li></ul><ul><li>CTM production for Phase I, II, III studies </li></ul><ul><li>Full CTM formulation, manufacturing, packaging and release testing </li></ul><ul><li>IND and IMPD support documentation (CMC) </li></ul><ul><li>Full quality support for all clinical materials </li></ul>Contract manufacturing & packaging
  • 11. GMP certified manufacturing plant <ul><li>Manufacturing of all types of dosage forms: parenteral solutions, lyophilized sterile products, ophthalmic drops, suspensions, emulsions, topical creams, capsules and tablets </li></ul><ul><li>Clinical supplies and testing of cytotoxics and scheduled drugs </li></ul>
  • 12. GMP certified manufacturing plant <ul><li>Sterile manufacturing of injectables and lyophilized powders in Class 100 (ISO 5) clean rooms </li></ul><ul><li>Validation of aseptic filling into vials, syringes or dropper bottles </li></ul>
  • 13. Certified Manufacturer of : Raviten injectable solution Ravimig tablets
  • 14. <ul><li>Lyophilized formulation of peptide with increased stability and safety </li></ul><ul><li>Formulation development and GMP manufacturing of freezed-dried vaccine formulation with a very limited amount of API </li></ul><ul><li>Repositioning of a generic drug as a slow release tablet formulation with improved pharmacokinetic profile for new indication </li></ul><ul><li>Formulation of water-insoluble anticancer drug with maximal bioavailability </li></ul><ul><li>Process development, upscaling and GMP manufacturing of sterile implantable protein gel for cartilage regeneration </li></ul><ul><li>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 </li></ul>Successful case studies of formulated products
  • 15. <ul><li>Development of analytical methods for stability and release of new transdermal patch </li></ul><ul><li>Compatibility and stability studies for two different new insulin pumps </li></ul><ul><li>Development of analytical assays for washing solutions of a stent for coronary vessels </li></ul><ul><li>Development of analytical methods and testing of cleansing solution for wound treatment </li></ul>Nextar’s GLP studies contribute to registration of new combined medical devices
  • 16. <ul><li>Achievements </li></ul><ul><li>No. of projects performed: 570 </li></ul><ul><li>No. of current customers: 120 </li></ul><ul><li>Over 50 innovative formulations developed </li></ul><ul><li>Process development, upscaling & manufacturing of over 25 products for clinical trials </li></ul>
  • 17. Our Advantages <ul><li>High-quality, cost effective, reliable and integrated chempharma solutions, for a full range of pharmaceutical and analytical services </li></ul><ul><li>Complies with international trend for outsourcing </li></ul><ul><li>One-stop-shop with GLP/GMP certifications </li></ul><ul><li>Formulation and manufacturing services optimized to accelerate your drug candidate to early clinical stage </li></ul><ul><li>Regulatory advice through drug development process </li></ul><ul><li>Significant saving of time and money </li></ul><ul><li>Flexibility and transparency </li></ul>
  • 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

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