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cGMP Manufacturing

AGC Biologics has successfully manufactured more than 200 biological projects, from pre-clinical studies through commercial approvals.

We offer multiple cGMP manufacturing lines at a variety of scales for mammalian cell culture and microbial fermentation, with facilities in Berkeley, CA; Seattle, WA; Copenhagen, Denmark; Heidelberg, Germany; Yokohama, Japan; and Chiba Japan.

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Article: Pharma's Almanac

Quality by Design: Transforming 21st Century Pharmaceutical Manufacturing

Abstract:

The Quality by Design (QbD) concept has been widely adopted as a standard of practice for manufacturers, including those in the automotive, semiconductor, electronics and chemical processing industries.

Regulators have also embraced QbD as a means to modernize the regulation of pharmaceutical manufacturing and product quality through manufacturing science, based on methodologies proven across countless applications.

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Facilities

We are a global full-service company offering comprehensive solutions to the Biotech and Pharmaceutical industries. Our integrated network of facilities allows our clients to access our services from anywhere in the world.

From early-phase to commercial-phase; AGC Biologics is uniquely agile and flexible to accommodate our clients' customized requests.

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