Daily Newsletter

16 August 2023

Daily Newsletter

16 August 2023

AGC and Asahi partner for clinical drug production in Seattle

AGC Biologics runs multiple mammalian cGMP manufacturing lines at the Seattle facility.

August 16 2023

AGC Biologics has entered an agreement with Asahi Kasei Pharma to produce clinical drugs for antibody-based therapies at its Seattle manufacturing site.

AGC Biologics will use Asahi’s monoclonal antibody development and manufacturing experience to perform process transfer, process optimisation and clinical manufacture.

Scientists at the Seattle manufacturing site will also support Asahi in submitting regulatory documents, manufacturing the product and preparing it for late-phase procedures.

AGC Biologics chief business officer JB Agnus stated: “Our company has a strong history of antibody production, and we pride ourselves on offering the flexibility and the technical expertise to meet any drug substance need at this critical clinical phase.

“We look forward to partnering with Asahi Kasei Pharma to help achieve their goals with this important project.”

At the Seattle facility, AGC Biologics runs multiple mammalian cGMP manufacturing lines at various scales for mammalian and microbial biologics.

It also serves as a centre of excellence for formulation, and utilises the latest fed-batch and perfusion manufacturing processes.

With a range of biologics products in production, the site recently expanded to add a new microbial-based manufacturing line system.

Digital transformation of the healthcare industry is driving the demand and development for precision and personalized medicine

Per GlobalData estimates, the precision and personalized medicine market is expected to achieve a CAGR of more than 43% between 2022 and 2029. The digital transformation of the healthcare industry is driving the market demand. For example, advances in biomarker testing with NGS are improving patient selection, use of AI in identifying trends in big datasets is accelerating the time from drug discovery to commercialization, and the use of Industry 4.0 technologies is improving the quality and efficiency of manufacturing complex drugs such as cell and gene therapies.

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