Validated success CMC Biologics

VALIDATED SUCCESS

CMC Biologics is a global technology leader in the development and manufacture of biopharmaceutical products. Philip Yorke talked to Patricio Massera, the company’s site head and general manager in Copenhagen, and Stacie Byars, director of global marketing, about the company’s recent business development successes and move towards more commercial manufacturing.

CMC Biologics AS was founded in Copenhagen, Denmark, in 2001 in order to provide faster and more effective solutions to the biopharmaceutical industry and to satisfy the need for outsourced development and manufacturing resources. In order to meet these growing global requirements, CMC Biologics expanded into the US market in 2008 through the acquisition of the ICOS Corporation in Seattle, and in 2012 with the acquisition of the Xoma facility in Berkeley, US. Today CMC Biologics employs more than 400 people with experience in 115 molecules to provide solutions to 85 customers on five continents.

CMC Biologics offers its clients a full suite of specialised contract services from DNA to API, and leverages its technical acumen to transform these services into solutions that perfectly meet its customers’ near- and longterm bio-manufacturing objectives. With its cGMP compliant facilities in Europe and the US, every project is performed to meet precisely its customers’ contracted requirements. As the largest dedicated, independent biologics contract manufacturer in the world, CMC Biologics has an enviable track record for validated clinical success.

Diverse production capabilities

CMC Biologics operates cell culture production in Seattle, and both cell culture and microbial facilities on a broad scale in Copenhagen. Furthermore, its diversity of production methods provides its clients with the capacity and flexibility they need to achieve their manufacturing goals throughout a product’s life cycle. At its global manufacturing facilities, CMC Biologics operates multiple cGMP manufacturing lines as well as a variety of scales. The company’s uniflow design allows for technological flexibility and the adoption of single-use systems, whilst ensuring full compliance with current ICH guidelines. Whatever the challenge, the diverse facilities available at CMC Biologics’ state-of-the-art global facilities ensure that the optimal clinical and commercial solutions are achieved.

Massera said, “We have upgraded and expanded our facilities both in Denmark and the US with a vision of becoming a major player as a commercial manufacturer. We are well known for our expertise in providing material for development in clinical trials and are now authorised by regulatory authorities for commercial manufacture. Our first commercial manufacturing project in Copenhagen is scheduled for filing early 2015. Today we manage projects from DNA to API, including cell-line development, upstream and downstream process development, analytical and formulation development, and clinical and commercial manufacturing services.

“In 2013, CMC Biologics made an important capital investment in the Copenhagen biopharmaceutical manufacturing facility

which optimises segregation of unit operations and improves flow of materials and personnel. The enhanced layout now maintains a fully unidirectional return corridor and exit airlocks to achieve exceptional manufacturing quality standards. As part of the upgrade we also improved our HVAC units and implemented new disposable transference lines. A similar investment was carried out in 2011 in our Seattle facility to increase capacity and support commercial manufacturing; and it is anticipated to expand further in 2015 to satisfy a recent large customer to produce its commercial supply.”

Massera added, “We differ from our competitors in many respects. We are able to manage very complex issues and in many instances have projects referred to us because others cannot match our science. We are also different in the way we work with our customers as we provide complete solutions and go well beyond the scope of everyday customer services. Helping our clients balance their manufacturing risks and rewards requires much more than engineering a production cell line, or completing a cGMP validation run. It means understanding how CMC Biologics can deploy its capabilities throughout a molecule’s life cycle and working in partnership with clients to assemble our combined resources in order to meet their manufacturing needs precisely on time.”

Advancing process development

In July, CMC Biologics entered into an agreement with Portola Pharmaceuticals, one of the largest strategic engagements of CMC Biologics’ history. Under this agreement, Portola

will expand its manufacturing commitment at CMC Biologics to include commercial supply for a Biologics License Applications (BLA) filing, which is expected to be filed at the end of 2015, and initial product launch in the United States. Portola is impressed by the quality of CMC Biologics’ infrastructure and demonstrated expertise in manufacturing complex proteins and coagulation factors. Massera adds, “We deliver on our promises to our customers, and are committed to providing solutions to our customers.”

Recently CMC Biologics and Zymeworks of Vancouver entered into a significant agreement for process development and the clinical manufacture of Bi-specific Antibody Product Candidate. Zymeworks is a world leader in the development of anti-body therapeutics and is known for developing ‘best-in-class’ protein therapeutics. Through the new agreement Zymeworks and CMC Biologics will work together to advance the frontier of bi-specific antibody development platforms and bring novel therapies to patients in need worldwide.

This new area of activity complements CMC’s existing range of contract services, which include cell line development, process development, analytical development, formulation development and stability studies. In addition, the company offers clinical manufacturing and commercial manufacturing as well as a well-defined range of quality services.

Byars said, “CMC Biologics is leading the industry among our competitors and we have a global multifaceted marketing platform which is designed to demonstrate our technical acumen and focus on customer satisfaction, bar none. We are very proud of our unprecedented growth rate, but in particular, our sterling reputation across the biologics community.” n

For further details of CMC Biologic’s range of products and dedicated biopharmaceutical services visit: www.cmcbio.com