BioTechnique

BioTechnique is a contract manufacturing organization that provides standard and highly-customized cytotoxic and high potency sterile injectable liquid & lyophilized fill-finish services.Our state-of-the-art ISO Class 5 manufacturing facility is also equipped with a full-scale microbiology lab and offers regulatory affairs, laboratory, and project management support from investigational/clinical all the way through phase IV/commercial.Facility Capabilities: • Sterile injectable manufacturing & packaging for liquid & lyophilized products • Aseptic Vial Filling • Aseptic Lyophilization • Inspection • Formulation • Product Testing • Labeling/Packaging • Stability Storage • Process Design • Full service laboratory • Regulatory affairs support for product filings • Project management Product Capabilities: • Cytotoxics • Highly-Potent Compounds • Monoclonal Antibodies • Antibody Drug Conjugates (ADC) • Suspensions • Inactivated & Attenuated Live VaccinesFilling & Manufacturing Capabilities: • Grade A / ISO 5 Aseptic Filling Suite • 2mL to 100mL vials • 0.2mL to 100mL fill volume • Inline fill volume check weighing • RABS • 144 sq.ft. Lyophilizer • Containment Unloading • Grade A / ISO 5 Capping • Post-Fill / Post-Lyo External Vial Rinse • Single-Use Disposable Manufacturing Train • Vial Inspection & Labeling • ICH Guideline Cold Storage • 2 to 8 ℃ • -20 to -70 ℃ • Stability Chambers & Warehouse Storage • Microbiology & Chemistry Labs • ISO 7 Formulation Suite with Flexible Wall Isolators