nextar presentation
TRANSCRIPT
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Contract Formulation Development, Manufacturing &
Analytical ServicesCompliant with
cGMP, GLP, ISO 13485 and ISO 9001
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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
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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
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Departments
• Chemistry Lab• Formulation Lab • Analytical/QC Labs• GMP Plant• QA/RA
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Spectrum of Services
Formulation development
QA/QC services
Method development & Validation
Bioanalytical ServicesRaw material testing
& releaseGMP Production
Custom chemical synthesis
Packaging for clinical trials
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Custom chemical synthesis
•Active pharmaceutical ingredients (API)
•Intermediates
•Impurities
•Metabolites
•Reference standards
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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
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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
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• 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
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• 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
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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
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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
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Certified Manufacturer of:
Raviten injectable solution
Ravimig tablets
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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
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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
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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
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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
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Our team
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We will be happy to assist you with your chemparma
needs
Web: www.nextar.co.ilSales/Projects: [email protected] CEO: [email protected]: +972-73-2244410