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 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 Vaccines Filling & Manufacturing Capabilities: Grade A / ISO 5 Aseptic Filling Suite 2mL to 100mL vials 0.2mL to 100mL fill volume Inline fill volume check weighing Isolator 13M2 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 C -20 to -70 C Stability Chambers & Warehouse Storage Microbiology & Chemistry Labs