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PROTEIN THERAPEUTICS MANUFACTURING SERVICES

cGMP Manufacture and Fill 

AppTec, a GMP/GLP contract manufacturing and testing company, offers a unique single-source, fully integrated approach for development of biotherapeutic protein products produced from mammalian cell culture.   Proven competencies provided by AppTec cover the full spectrum of therapeutic recombinant protein and monoclonal antibody development – from preparation and testing of cell banks, through cGMP clinical manufacture and lot release testing of bulk drug substance and final drug product. 

Technology Transfer

AppTec's scientific expertise and multifunctional project teams allow for efficient transfer of sponsor methods, assays and processes.  The transfer of information and initial methods verification provides both AppTec and the sponsor with a defined baseline to measure effects of operating procedures, raw materials, manufacturing scale-up, process optimization, protein characterization and product release criteria. 

Bulk Drug Substance (BDS) Production

Five BDS suites, designed for maximum flexibility, are available for client projects on a campaign basis.  Each BDS suite comprises separate cell expansion, bioreactor and downstream processing areas.   

Mammalian Cell Culture Capacity

•  Two 500 L Bioreactors

            (100 L and 500 L trains)

•  One 2,500 L Bioreactor

            (100 L, 500 L and 2,500 trains) 

Downstream Technologies

•  Cell Culture Clarification

     Depth Filtration

     Tangential Flow Filtration

•  Chromatography

     Ion Exchange

     Affinity

     Size Exclusion

     Reverse Phase

     Hydrophobic Interaction (HIC)

•  Viral Clearance

     Nanofiltration

     Solvent Detergent

     Low pH

•  Ultrafiltration and Diafiltration

•  Custom Process Steps 

Final Product Formulation & Fill

AppTec offers final drug product formulation and filling under cGMP conditions as defined by the various regulatory agencies and the Code of Federal Regulations (CFR).

•  Up to ~1200 Vial Lot Size

•  Class 100 Environment

•  Standard Glass Vial, Rubber Stopper, Metal Seal (1-50 ml)

   Container Configurations 

Project Management

AppTec provides a dedicated project manager to oversee all aspects of a sponsor's project, serve as a single point of contact to streamline communication, and interface with all project team members to ensure project timelines and cost objectives are met.  To facilitate sponsor interaction throughout the project, AppTec developed dedicated space for sponsors to work on-site during technical transfer, while assisting in critical project phases, or as a "person-in-plant."