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I Mak

Chatting With CMC

Conversation at BIO 2012

By: Mak Jawadekar

Contributing Editor

BIO International Convention: The Global Event for Biotechnology! Indeed, it lived up to the billing. I spent four days (June 18-21st) at the BIO Convention in Boston, along with more than 15,000 delegates from the U.S. and around the world. It indeed was a showcase of innovative technologies, as well as a networking event to connect with potential partner companies and individuals. I took time to meet with many companies that are offering services to big biotech and pharma companies for contract R&D and manufacturing services.
 
I really thought that the stars are in complete alignment for CMC Biologics, a CMO known for its technical prowess in process development and cGMP manufacture out of its sites in Copenhagen, Denmark, and Seattle, WA. The company had three significant events that are considered by industry experts to be game-changers! I took time to sit down and talk with Gustavo Mahler, CMC Bio’s chief operating officer and also met and spoke with his colleagues, Stacie Byars and Laura King, who are helping the company grow and make the necessary connections for potential partnerships.
 
I captured several highlights as to how CMC Biologics intends to differentiate itself from other providers as it tries to partner with big biotech and pharma companies around the globe.
The company achieved successful European GMP inspection by MHRA for commercial manufacturing, a key milestone in its strategy. The company’s growth strategy is centered on revenue from commercial manufacturing and it hopes to achieve its goals with long-term commercial supply agreements with two large customers. CMC Biologics is the exclusive manufacturer (at least six years) with Inspiration Biopharmaceuticals, manufacturing intravenous recombinant factor IX product for the treatment and prevention of bleeding in individuals with hemophilia B. It’s also the leading manufacturing partner is Daiichi Sankyo, providing process development support and manufacture of several clinical stage antibodies during a three-year period. The company’s obvious hope is that Daiichi will soon move to commercial manufacturing, and stay with CMC as its partner of choice. The company also launched two new service offerings at BIO:
 
1. Get antibody produced Right. On Time. For 2 Million Euros, CMC Bio delivers 500g of monoclonal antibody manufactured under GMP in a remarkable 12-month timeframe. That offer is guaranteed, according to Mr. Mahler, who enumerated several reasons for the new program:
  • Monoclonal antibodies represent 60% of molecules under development
  • Current technology changes are commoditizing the monoclonal antibodies early development services
  • High titers and single-use technology reduce barriers of entry for smaller players
  • Platform technologies use is more expended and standardized
  • Larger players in the CMO field are trying to compensate low business intake by entering the early mAb development phase space with highly competitive offerings
  • CMC Bio’s ability to capture RFPs for early mAb development projects is very good, however, the company takes pride in taking on more complex and challenging development projects, according to Mr. Mahler. CMC now offers an accelerated, value- based mAb development platform to address this part of a highly competitive space of the contract development market.
  • A more competitive offering is required to recover market share in this space
 
2. Its comprehensive and sophisticated AFS services now comprise a standalone offering. Why? According to Mr. Mahler
  • The company’s scientific know-how and state-of-the-art laboratories, as well as cGMP services for every stage of drug development, are great magnets.
  • CMC Biologics has extensive experience, from Phase I through commercialization, developing and validating analytical techniques for complex proteins, glyco-proteins, clotting factors, enzymes, growth factors and antibodies.
  • They claim to have innovative scientific team — with an average of about 15 years’ industry know-how — to provide technical guidance needed to solve difficult analytical challenges. 
  • As a global biopharmaceutical CMO, their expertise in analytical method development and validation, and formulation development for therapeutic proteins, ensures high quality data in compliance with current cGMP requirements and ICH guidelines. 
  • They promise faster, more flexible development to speed product development to market. I believe their collaborative mindset should lead to long-lasting partnerships with customers across the industry.
The company’s fully integrated services include cell line development using its proprietary CHEF1 System, process and formulation development, and comprehensive analytical testing. CMC has fully segregated microbial fermentation and mammalian cell culture suits and offers stirred tank and perfusion production processes.
 
I believe that CMC Bio’s value proposition offers a stable, well characterized mAb cell line, a platform antibody system that will include 500g of mAb manufactured in Phase I/II process, which is scalable for late Phase and commercial production, along with accelerated stability data at preferred pricing. I have enough reasons to believe that they are nimble, flexible company with great resources and technical know-how. It is a company worth taking a close look at when one is considering contract biologics R&D and manufacturing!  
Makarand (Mak) Jawadekar most recently served as Director, Portfolio Management and Performance at Pfizer Global R&D, until February 2010, when he opted for an early retirement after 28 years at Pfizer Inc. He currently serves on several companies’ advisory boards and also consults with bio/pharmaceutical companies for global outreach in emerging market regions. He can be reached at mjawadekar@yahoo.com.

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