AGC Biologics
Transforming Drug QA with cGMP Practices

Today, pharma companies, big or small, are increasingly facing challenges related to regulatory non-compliance. A key reason behind a majority of such instances is the inadequate quality of trial samples, which is a problem-driven by inefficient quality assurance practices and processes. On the one hand, smaller pharma firms lack the expertise and resources to establish a QA infrastructure capable of ensuring foolproof compliance and high-quality samples. While on the other hand, even larger pharma firms that invest in state-of-the-art quality and testing equipment fail quality checks due to insufficient expertise in the latest developments in the pharma regulatory space, which stymies the precise translation of emerging mandates. Seattle, Washington-based AGC Biologics addresses this need for effective and compliance-driven quality assurance with its integrated quality management system and extensive regulatory track record.

Founded in 2018 as a convergence of Japan-based Asahi Glass Company (AGC) Bioscience, Biomeva GmbH (Heidelberg, Germany), and Denmark-based CMC Biologics, AGC Biologics was established with a mission to offer microbial and mammalian cell lines for early-phase processes through late-phase projects and beyond into routine commercial production. Since then, the company has acquired additional facilities and companies worldwide, expanding its offerings and creating a solid global network of end-to-end manufacturing sites stretching across three continents. In fact, with its August 2021 acquisition of Novartis Gene Therapies’ 622,000 square feet facility in Longmont, Colorado, AGC Biologics now has a total of seven facilities (one site in Chiba, Japan, three in the U.S., and three in Europe) across the globe.

As a CDMO proven for its high standard of service, AGC Biologics is committed to leveraging its deep industry expertise and unique customized services for the scale-up and cGMP manufacturing of protein-based therapeutics. The company’s quality assurance capabilities come under its integrated service offerings, including cell line development, bioprocess development, formulation, analytical testing, antibody-drug development and conjugation, cell banking and storage, and protein expression—including their proprietary CHEF1 Expression System for mammalian production.

AGC Biologics offers its integrated quality management system (QMS), which incorporates requirements from the U.S., E.U., and ICH quality assurance guidelines. The system is also validated by the FDA, European Medicines Agency (EMA), Danish Medicines Agency (DMA), Paul Ehrlich Institute (PEI), as well as the Health Canada and the Pharmaceuticals and Medical Devices Agency (PMDA).

“Our integrated QMS combined with our cGMP expertise helps us support our clients in not only performing in-process, intermediate, and final product testing but also choosing the best-suited analytical technique for the validation of raw materials, reference samples, and more,” says Tina Guldberg, vice president of quality at AGC Biologics.

Furthermore, the company’s emphasis on accurately aligning its offerings with client-specific requirements is perfectly illustrated by the placement of seasoned QA veterans at the helm of three of its seven facilities. The company’s cGMP expertise also enables its clients to accelerate their drug development processes efficiently and reliably, while AGC Biologics’ validated and proven QMS supports the establishment of robust QA processes. With such unmatched capabilities, the company has ignited several success stories where AGC Biologics has assisted clients in reducing drug development and production costs while boosting their go-to-market times and eliminating instances of regulatory non-compliance.

In the current pharma marketplace, shrinking deadlines and evolving regulatory mandates are driving significant losses by hindering several drug manufacturers from bringing their products to market. To mitigate this, AGC Biologics will continue offering its integrated QMS and cGMP-focused CDMO services to assist clients in always remaining compliant with the latest mandates and bringing their products to market in a timely and cost-effective manner.