Process Development OVERVIEW PROCESS DEVELOPMENT Cell Line Development Upstream Process Development Downstream Process Development Analytical Development CGMP MANUFACTURING PLASMID DNA VIRAL VECTOR CELL THERAPY QUALITY AND REGULATORY PROCESS VALIDATION UPSTREAM PROCESS DEVELOPMENT Each step in an upstream process impacts the quality, purity and quantity of the manufactured protein. At AGC Biologics, we have developed over 80 mammalian, bacteria and yeast based processes in the last decade, giving us the insight necessary to identify and optimize upstream parameters that are critical for achieving a high-quality, cost-effective biomanufacturing process. Our process transfer platform is well-substantiated and designed to scale-up directly, from bench-scale to final manufacturing scale, accelerating your development timelines. Utilizing our proprietary CHEF1TM expression platform, development timelines can be optimized further. Our approach is flexible, based upon our clients’ needs. We can develop bioprocesses “from scratch” for customers with no existing upstream process, or we can redesign and optimize an existing process. In addition, our development team is experienced with fast and effective technology transfer to establish proven cell culture and microbial fermentation processes. This ensures that you receive a seamless route to scale-up and cGMP manufacture. Our upstream mammalian and microbial development capabilities include: Reliable transfer, verification and optimization of clients’ bioreactor process Scale-down fed-batch and perfusion production models Platform bioreactor processes for a variety of mammalian and microbial expression platforms Extensive experience with multiple mammalian cell types, including CHO DG44, CHOK1, HEK293, NS0 and PerC6 Broad expertise with multiple microbial expression systems, including E. coli, Pseudomonas, Pichia and Saccharomyces cerevisiae Inclusion bodies, soluble intracellular and secreted to periplasm High cell density and titer optimization with multiple host cells (mammalian, bacteria and yeast) Extensive experience screening media and feeds Bench-scale process characterization and validation ABOUT CAPABILITIES RESOURCES FACILITIES NEWS & EVENTS LEGAL & COMPLIANCE CONTACT US Follow us on LinkedIn Follow us on Twitter Follow us on Facebook NEWS AGC Biologics Appoints Jean-Baptiste Agnus as Chief Business Officer AGC Biologics Expands pDNA and mRNA Manufacturing Capacity AGC Biologics Announces the Groundbreaking of its New Facility at its Copenhagen, Denmark Site AGC Biologics Appoints Tony Fraij as the new General Manager/Site Head of the Longmont, Colorado Site AGC Biologics Acquires Commercial Facility, Expanding Cell & Gene Therapy Global Service Offerings EVENTS Cell & Gene Meeting on the Mesa, October 12-14, 2021 AGC Biologics is Attending BIO Asia-Taiwan July 23-26, 2021 Presenting Our Biological and Cell & Gene Therapy Capabilities AGC Biologics is Attending ASGCT May 11-14, 2021 and Presenting Our Scalable LVV Production Process and Large-Scale AAV Manufacturing Development Data AGC Biologics is Attending Meeting on the Med, April 6-9, 2021 FACILITIES SEATTLE, WASHINGTON (Headquarters) BOULDER, COLORADO LONGMONT, COLORADO COPENHAGEN, DENMARK HEIDELBERG, GERMANY MILAN, ITALY CHIBA, JAPAN ©2021 AGC Biologics. All Rights Reserved. Website Privacy Policy