Meeting Biopharma Contract Manufacturing Needs with a Flexible Global Network

As biologic drugs become more complex and sophisticated, biopharmaceutical companies increasingly need the support of contract development and manufacturing organizations (CDMOs) with advanced capabilities and technology platforms that are consistently implemented across scales and geographies. With multiple sites around the globe, AGC Biologics has the flexibility and expertise needed to meet the ever-changing demands of this rapidly evolving sector.

Demand for contract development and manufacturing services in the biopharmaceutical sector is rising around the world, as growing numbers of biologic drugs — from antibodies to next-generation cell and gene therapies — continue to achieve success in the clinic and move toward commercialization. Expansion of
the biosimilar and follow-on biologics markets, particularly in Asia and also in South America, is also fueling the need for support from CDMOs that can provide cost-effective, accelerated development and commercialization pathways.

Careful Convergence

To help reduce project costs and timelines, biopharmaceutical companies are looking for CDMO partners with established global networks of facilities and advanced technical capabilities that use the same technology platforms across locations and development phases. In response to this need, AGC Biologics was formed. The name reflects aspects of each of the brands brought together to form the company and the reputations they have earned in the marketplace. 

The convergence and integration of Asahi Glass Company (AGC) Bioscience, Biomeva GmbH and CMC Biologics have generated a CDMO with deep industry expertise in both mammalian cell culture and microbial fermentation methods for the scale-up and cGMP manufacture of protein-based therapeutics, from pre-clinical to commercial production. With global heads of Quality, Project Management, Business Development and all other key activities, AGC Biologics ensures that the same systems, technologies and management practices are implemented at all sites. As a result, transfer and scale-up of projects as they move from early to late-phase or expand to meet demand in new geographies can occur seamlessly within our global network.

AGC Biologics has made significant investments to align our development groups and technology platforms across all regions for both upstream and downstream processing. Importantly, AGC Biologics has deployed unique technologies that enable acceleration of development timelines, getting customer projects from the DNA stage to IND filing in less than 14 months. We work side by side with our customers to bring their products to market as quickly as possible. That includes rare-disease treatments and personalized medicines, to more traditional antibodies and products with accelerated approval pathways.

Customer Support from Early Phase to Commercial

For customers with phase III and commercial products, access to flexible capacity is essential. AGC Biologics meets that need with our Bioreactor 6Pack™ manufacturing platform consisting of six x 2000L bioreactors. Customers can begin with production in one bioreactor and scale up as needed, in response to real demand. We also employ a number of solutions designed to enable rapid development and validation. The combination of flexible capacity that grows as needed and the ability to work on accelerated pathways makes it viable for our customers to get their high-quality treatments to patients as quickly as possible.

Continual Investment

Ongoing investment in facilities and capabilities is a key component of our strategy for growth at AGC Biologics. In early March 2018, we announced the addition of a 2000L single-use bioreactor (SUB) as part of a production expansion project at our Berkeley, California facility. Capacity at this site has tripled in the last three years and now offers cell culture manufacturing from 100L to 3000L in both SUB and stainless-steel bioreactors to support early-phase projects.

Later that same month, we announced the addition of a new building complex that will house the company’s global headquarters in Bothell, Washington. Spanning more than 150,000 square feet, the addition will be located next to the existing AGC Biologics facility and house Process Development labs and Corporate Administrative offices, as well as provide expansion space for additional manufacturing capacity. It will also include a new R&D center dedicated to novel manufacturing technologies for faster development of therapeutic proteins.

These investments underscore our commitment to meet the growing needs of our customers for both mammalian and microbial development and manufacturing services. They will also enable us to further integrate the development, manufacturing and commercial functions at our global headquarters and reinforce the effectiveness of our extensive global network. 

Gustavo Mahler, Ph.D.

Dr. Gustavo Mahler is a Venture Partner of Dynamk Capital LLC, having served as an Advisor to Dynamk since 2017. In 2015, Dr. Mahler became CEO of CMC Biologics, and he was a key player in the sale of CMC Biologics to the Asahi Glass Corporation in 2017. Dr. Mahler holds a Ph.D. in Biochemistry from the University of Buenos Aires, an MBA from the University of Madrid and a Leadership and Management Certification from MIT Sloan School of Management.