Process Development
Our expertise spans biologics using mammalian and microbial systems, cell therapies, and viral vectors
Upstream Process Development
Each step in an upstream process impacts the quality, purity, and quantity of the manufactured protein, cell therapy or virtual vector product. At AGC Biologics, we have teams with 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.
In addition, our development team is experienced with fast and effective technology transfer to establish proven processes. This ensures that you receive a seamless route to scale-up and cGMP manufacture.
Downstream Process Development
Downstream processes for monoclonal antibodies, recombinant proteins, complex glycoproteins, bacteria and yeast, cell therapies, and viral vectors.
We have established downstream platforms that allow us to move quickly into a product’s manufacturing phase. Our experience also enables us to develop more customized and innovative solutions to meet our customers’ evolving needs.
We optimize our downstream processes to remove impurities and increase yields with minimal steps and optimal recovery, leading to more cost-efficient manufacturing.
Our downstream process development and analytical teams are fully integrated to ensure we achieve the product quality attributes. One example includes our tailoring of processes to remove undesired product variants, such as under-sialylated molecules, aggregates and oxidation variants.
AGC Biologics has partnered with Gore to improve downstream purification
Visit our landing page to learn more or read the press release here.
Systems analysis: Eliminating Downstream Bottlenecks
View this article to understand how AGC Biologics and Gore are working together to reduce expenses, speed up timelines, preserve materials, and optimize facility use.
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