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 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