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For a printer-friendly version, click here. To access our Biotech/Biopharm catalog of services, click here. PROTEIN THERAPEUTICS MANUFACTURING SERVICES Process Development Capabilities 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. Upstream (Mammalian Cell Culture) Process Development AppTec's cell culture process technology platform provides for optimization of media, seeding densities, feeding and bioreactor process control strategies to maximize expression, enhance process reproducibility and facilitate scale-up. • Adaption of cell line to suspension culture process • Adaption of cell line to serum-free/animal protein-free media • Media optimization and evaluation • Development of bioreactor process from shake flask and stationary culture process • Cell culture characterization and optimization • Scale-up • Analysis of risk and cost benefits for various types of cell culture processes Downstream (Recovery and Purification) Process Development AppTec's downstream process development program will optimize yields, improve product purity and provide a robust and reproducible purification process using technologies and raw materials suitable for cost-effective large-scale manufacturing. • Clarification development (depth filtration, dead-end filtration, TFF) • Chromatography purification optimization (IEX, Affinity, HIC) • Chromatography resin screening • Chromatography resin dynamic binding capacity studies • Chromatography resin lifetime, aging and cleaning studies • Forced degradation studies • Viral inactivation and viral filtration development (nanofiltration, low pH) • Scale-down process characterization for viral clearance studies • Scale-Up • Analysis of risk and cost benefits for various purification process unit operations Technology Transfer AppTec's scientific expertise and multifunctional project teams allow for efficient transfer of methods, assays and processes from clients. This transfer of information (and its initial verification) provides both AppTec and the sponsor with a defined baseline by which to measure the effects of operating procedures, raw materials, manufacturing scale-up, process optimization, protein characterization, and product release criteria. Analytical Development and Support AppTec provides ongoing analytical support to process development and manufacturing operations. Assays are developed and validated for in-process analysis, bulk and final product stability studies, and final product quality control (sterility, purity, potency, identity and concentration). 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." Process Development Technologies • Mammalian Cell Culture Systems Flasks (all types) Roller Bottles Spinner / Shake Flasks Wave BagBioreactors • Cell Culture Clarification Depth Filtration Tangential Flow Filtration Centrifugation • Ultrafiltration and Diafiltration • Custom Process Steps • Chromatography Ion Exchange Affinity Hydrophobic Interaction (HIC) Mixed Mode Chromatography • Viral Clearance / Inactivation Nanofiltration Low pH Chromatography
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