BioTechnique

Pharmaceutical ManufacturingPennsylvania, United States11-50 Employees

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 ℃
                    • -20 to -70 ℃
          • Stability Chambers & Warehouse Storage
          • Microbiology & Chemistry Labs

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