Because medical patients depend on pharmaceutical corporations to produce medicines they need to treat an ailment, it is imperative these organizations maintain a reputation for reliability. Consumers may assume their medicine comes from within the walls of big-name pharmaceutical companies, but in actuality, many of the industry’s giants turn to contract manufacturing organizations (CMO) to develop and mass-produce certain products. Therefore, a pharmaceutical company’s reputation – not to mention the consumer’s well being – ultimately is in the CMO’s hands.
CMC Biologics is a CMO that develops bioprocesses and manufactures biological therapeutics on behalf of drug companies worldwide.
Founded in Copenhagen, Denmark, in 2001 and with a site in Bothell, Wash., CMC provides drug developers with a “global strength in meeting demanding regulatory requirements and delivering compliant quality standards,” it says. “With facilities in both North America and Europe, we reach clients from all over the world, and work in close collaboration with the Federal Drug Administration (FDA) and the European Medicines Agency (EMEA).”
CMC Biologics created CHEF1®, a development platform for the stable delivery of production-quality cell lines in rapid timeframes, which enables its customers to choose the production system complementary to their goals. “CMC Biologics’ cell line development services include a fast and efficient platform for standard cell line development as well as custom services capable of meeting specific customer needs,” it says.
The company specializes in mammalian and microbial cell line development. Its mammalian cell line development platform integrates CHEF1 high-productivity expression plasmids; superior serum-free, suspension-adapted CHO cells; and custom production media.
“All three components of this integrated platform have been co-developed to create optimal growth conditions yielding high cell densities resulting in consistent, stable expression of our clients’ proteins in rapid timeframes,” it explains.
“CMC Biologics’ microbial cell line development group has extensive experience in establishing, optimizing and characterizing high cell density E. coli and Pichia fed-batch processes,” the company continues. “For E. coli suitable expression vectors and host strains are available and the microbial Cyclic guanosine monophosphate (cGMP) cell banking services are embedded in the development group. The overall focus is to develop high-yielding cell lines and processes that are robust and scalable, with high productivity in regulatory friendly media.”
One-Stop Biotech Shop
CMC Biologics does not offer in-house products but instead concentrates solely on contract manufacturing. “Each of our customers face different challenges, and our combination of mammalian and microbial production capabilities is one aspect of delivering the most appropriate solutions to meet those particular challenges,” the company says.
Dr. Gustavo Mahler, president of CMC’s U.S. operations, says CMC’s “one-stop shop approach,” is a benefit to its clients. “We will work with any company trying to develop a product for the market – mainly for human pharmaceuticals, although we do provide for a small number of veterinarian applications,” he notes.
“We can start with simple information from DNA sequence that is the code for the manufacturing of a biotechnology-based pharmaceutical,” Mahler adds. “CMC can manufacture the material for clinical testing and development. We can also provide commercial manufacturing to produce these pharmaceuticals on a large scale. We have a very strong reputation for delivering on time and with high-quality standards.”
Meeting Quality Guidelines
CMC works with approximately 15 to 20 clients at a time. “In many cases, we will develop more than one product for the same customer,” Mahler says. “One of the key strategies of our company is to focus on developing strong relationships with the customer. Due to our structure and size, we feel we are much more flexible than our main, large competitors.
“It’s mandatory for our customers to manufacture in compliance with regulatory requirements when they need to source a clinical or commercial product,” he adds. “According to FDA, the complexity and control required to meet the quality standards are higher the further you go in the development of a product.
“When you launch the product in the market, the quality standards you operate under need to be very tight, and not all CMOs are able to provide those quality conditions,” he points out. “We can provide our customers with the support and quality standards required to meet current good manufacturing practices for commercial manufacturing operations.”
CMC Biologics operates quality control and quality assurance departments. The main objectives of the quality control department are the control of raw materials, in-process stability and release testing analysis. Its quality assurance department is responsible for the enhancement of product and service quality, continuous quality improvement and to secure high customer satisfaction.
The Science Squad
A highly sophisticated company requires a highly sophisticated team. Nearly 60 percent of CMC’s 350-person staff has a bachelor’s degree or above, and about 30 percent of these individuals are scientists with doctorates. “We have a number of seasoned scientists in higher positions coordinating operations and development of new products,” Mahler says. “We also have a number of young scientists that are making their way at the company, working in the labs and developing new processes.”
Mahler received his doctorate in biochemistry from the University of Buenos Aires and an MBA in the UNED University in Madrid, Spain. Before joining CMC in 2008, he worked at Bayer in Argentina, Germany and the United States in different manufacturing and general management positions.
“CMC provides good opportunities for our employees because the company itself continues to grow steadily in the marketplace,” he says. “I think of CMC as a very progressive company if you take into account our size and the volume of new technology that we develop and deploy in the marketplace. We normally create for our customers eight to 10 new products a year applying innovative technology generated within CMC.
“Some applications and products can’t be disclosed because they are proprietary, and customers prefer confidentiality,” he notes. “But we gain a sense of satisfaction knowing we are developing products that will help people live better lives. Doing good science is more enjoyable when you can make productive and valuable contributions by applying it.”