• Rigorous testing compliant with cGMP (current good manufacturing practices) guidelines
• Endotoxin, sterility, and potency tests
• Sterile (intramuscular injections, intravenous, and eye drops) and Non-sterile (ointments, creams, liquids or capsules) preparations

• Clinical supplies manufacturing
• Clinical supplies packaging
• Scale-up
• Technical or Site Transfers
• Launch product(s) for commerce
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PRODUCTS in VIALS, PFS & CARTRIDGES

• Biologics: Antibodies, Antibody Drug Conjugate, Cell and Gene Therapies

• Innovative Drug Delivery Platforms: Injectables and Ophthalmic

• Small Molecules: Potent Compounds

• Specialized drug delivery technologies

AUTOMATED INJECTABLE FILLING LINE

• Glass vial filling equipment train (single use equipment, filling & stoppering, SIP/CIP, capping/ crimping, isolator) (model and specs. to be disclosed)

• Pre-filled Syringes, Cartridges & Vials: Multi-purpose filling line (tray technology)

• Freeze dryer for biologics and other pharmaceutical drug products (model and specs. to be disclosed)

• Change parts will be customized as per client product(s) requirements

• Pharmaceutical Development & QC Testing
• Formulation Development
• Biopharmaceutical Characterization
• Analysis of Impurities & Contaminants
• Protein & Peptide Identification
• In Vitro Toxicology Testing
• Specialty Product Analysis
• Biosafety Testing of Biologics, Antibodies, Gene &
• Cell Therapies
• Stability Prediction
• Extractables & Leachables Testing
• Package & Container Testing
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• Endotoxin

• Bioburden

• Sterility

• Microbiological tests & assay

• Bioanalytical / Analytical Testing

• Physiochemical Characterization

• Pharmaceutical Formulation

• Process Development & Validation