Biotechnique

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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

Company Details

Employees
38
Founded
-
Address
York, Pennsylvania 17406, Us
Phone
+1 717 377 3547
Email
in****@****que.com
Industry
Pharmaceutical Manufacturing
NAICS
Pharmaceutical and Medicine Manufacturing
Medicinal and Botanical Manufacturing
Pharmaceutical Preparation Manufacturing
In-Vitro Diagnostic Substance Manufacturing
Biological Product (except Diagnostic) Manufacturing
HQ
York, Pennsylvania
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