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AGC Biologics. Inc

AGC Biologics is a global CDMO providing development and manufacturing services for protein-based biologics and advanced therapies.

Business Category : Drug Substance, Drug Additives, Intermediate、CMO、Pharmaceutical manufacturing、Regenerative medicine treatment

Main Service Region : Japan、United States、Europe(excluding UK)、United Kingdom、Asia

Product & Service

Release Date : 2022/08/19

Release Date : 2022/08/19

Process Development

Service Category :Manufacturing

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. 

Process Development Expertise from Pilot through Commercial Scale

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. We have amassed the skills and resources to develop late-stage processes that utilize innovative production techniques, resulting in maximum scalability and efficient process transferability.

This expertise, combined with single-use and high throughput technologies, allows for rapid development and streamlined transfer, helping to accelerate your product development and commercialization timelines.

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