CMC Biologics has finished construction on a disposable manufacturing facility at its Seattle, WA, site. The addition comes as part of a staged expansion plan to bolster capacity for cGMP manufacture of biopharmaceuticals.
The multipurpose, single-use facility will allow for early-phase clinical manufacture of a range of biopharmaceuticals including mAbs and other mammalian cell culture-based recombinant proteins. CMC Biologics partnered with Hyclone to supply the new disposable facility with processing equipment including a 100 L and two 500 L single-use bioreactors (SUBs) and disposable mixers.
"As process yields continue to increase through advances in protein expression, cell culture, and purification technologies, the need for costly high-volume stainless steel tank facilities will decline for some products,” remarks Gustavo Mahler, president and CEO. "We believe this trend will continue to push bioprocessing toward single-use technology."
Andy Walker, senior director of manufacturing, adds, "Disposable technology offers the advantages of increased flexibility and efficiency, decreased cross-contamination risks, and elimination of cleaning, sterilization, and other change-over procedures typically associated with traditional steel-tank facilities, while providing the same performance. Consequently, it provides a cost-effective strategy for reducing the speed to market for many biologics."
For other products where use of disposables is not feasible, CMC Biologics continues to offer its stainless-steel clinical and commercial cGMP manufacturing facilities. Besides Washington, the firm also has a plant in Copenhagen.
CMC Biologics is increasing its capacity with the addition of a second 3,000 L bioreactor train, identical to the existing line. Recent client demand has prompted initial steps toward build-out of a pre-existing structure anticipated to house two 5,000 L commercial-ready manufacturing lines. CMC Biologics also reports increasing headcount by more than 30% at its Seattle site to support the expansion.
CMC Biologics, a contract development and manufacturing organization, specializes in custom services for the scale-up and cGMP manufacture of protein-based therapeutics for preclinical, clinical trials, and commercial production. It has fully segregated microbial fermentation and mammalian cell culture suites and offers both stirred-tank and perfusion production processes. The company’s services include cell-line development using its CHEF1® system, process development, and comprehensive analytical testing.
Utilizing the regulatory sequences of the Chinese hamster EF-1a (CHEF1) gene, CMC says that its vectors promote constitutive high-level expression of recombinant proteins early in development. A variety of CHEF1 vectors are available with different selectable markers permitting expression of heterodimeric proteins as well as modification enzymes to improve product quality or expression levels, the company explains.
The CHEF1 system allows rapid isolation of stable CHO cell lines because gene amplification is not required to achieve high-level expression, CMC adds. CHEF1 cell lines reportedly produce gram quantities of protein in seven to eight weeks from transfection and production-quality clones in 11 to 14 weeks.