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Process Development

Our expertise spans biologics using mammalian and microbial systems, cell therapies, and viral vectors.

Capabilities - Process Development

Our scientists apply decades of expertise to ensure the most effective processes for manufacturing your product at a pilot, clinical and commercial scale. Our broad knowledge of cGMP manufacturing enables us to successfully transfer existing processes into our facility or develop a new, innovative process when needed to meet your program objectives.

Mammalian, Bacteria, and Yeast-based Success

CMC_Berkeley_IPT_006_cropAt AGC Biologics we have developed over 200 mammalian, bacteria and yeast-based processes, giving us the insight necessary to identify and optimize process parameters that are critical for achieving a high-quality, cost-effective manufacturing process.

Developing an efficient, scalable, validated and cost-effective manufacturing process is essential for success in today’s competitive biologics markets. Whether you need assistance developing a de novo process, improving existing processes, or preparing to manufacture your product, you will benefit from our expertise.

Cell Therapy and Viral Vectors for Gene Therapy

Our cell therapy process development capabilities include a proprietary production platform for T-cells and HSCs transduction, process characterization studies, cell biology analytical testing and development, and more. 

AGC Biologics cellular biology laboratories have the ability to support important processes like CD34+ and T-cells transduction, as well as T-cell immunomagnetic selection, culturing, and transduction by viral vector. 

Our viral vector process development capabilities also utilize proprietary platforms (adhesion and suspension) for adeno-associated viral vectors (AAV), lentiviral vectors (LVV), and retroviral vectors (RV). The AGC Biologics viral vector process development services include process characterization studies, verification batches, and cell banking. 

For both cell therapy and viral vectors, we offer pilot batches and full-scale batches for new clients prior to transfer in GMP. 

Interested in learning more?

Contact our team