cGMP Manufacturing

CMC Biologics has successfully manufactured more than 120 biological projects for pre-clinical studies through commercial approvals. Our U.S. facilities in Berkeley, CA and Seattle, WA—and our European facility in Copenhagen, Denmark—offer multiple cGMP manufacturing lines at a variety of scales for mammalian cell culture and microbial fermentation.

The innovative design of our state-of-the art facilities allows for capacity and technological flexibility, while ensuring compliance with the strict biopharmaceutical regulations required for cGMP operations.

Our dedicated and experienced technical teams are committed to helping each client meet its clinical and commercial goals. Right. On Time.

MAMMALIAN CELL PRODUCTION

CMC Biologics has provided solutions to customers on five continents, and has developed more than 60 mammalian cell lines and processes from pre-clinical through commercial production. We have skillfully developed upstream processes for numerous expression systems, including our proprietary CHEF1® Expression Platform, which has been used extensively to create clinical and commercial production cell lines.

Our extensive experience enables us to identify and select cell types that meet specific parameters and characteristics, and to optimize our customers’ product attributes. Our CHEF1 Platform enables rapid and seamless process transfer of your product to cGMP manufacturing.


Our mammalian cGMP manufacturing capabilities include:

  • _G1A9479_crop.jpgHigh-quality cGMP manufacturing know-how and experience
  • Manufacturing success rates exceed industry standards globally
  • Expertise in process development and transfer enable processes to move seamlessly into cGMP manufacturing
  • Flexibility in cGMP manufacturing:
    • 100L, 500L, 750L, 2000L, and 3000L stainless steel bioreactors
    • 100L, 500L, and 2000L single-use bioreactors
    • 3 x 2000L Bioreactor 3Pack™ single use bioreactor suite
    • 6 x 2000L Bioreactor 6Pack™ single-use bioreactor suite
  • Option for single use/disposable solutions in all steps of manufacturing
  • Batch, fed-batch, and continuous perfusion operation
  • Drug substance available for shipping to drug product manufacturing site within weeks of bulk AP fill

Mammalian PERFUSION PRODUCTION

Perfusion manufacturing of biologics is the method of choice for difficult to produce or inherently unstable proteins. Due to this challenge, there are few companies out there that can do offer this service.   CMC Biologics has successfully produced several molecules using perfusion manufacturing methods, enabling us to offer it not only as a service, but as a solution to our customers’ manufacturing challenges.


Our perfusion cGMP manufacturing capabilities include:

  • 100L cGMP manufacturing line, with perfusion capacity up to 300L/day
  • cGMP manufacturing line in a 500L single use bioreactor, with perfusion capacity up to 1000L/day
  • cGMP manufacturing line with two 750L bioreactors, with perfusion capacity up to 1000L/day
  • BioSEP, ATF and other perfusion technologies

2.012 ACCELERATED MAB PLATFORM

Remove the uncertainty of getting cGMP material for clinical studies, allowing you to concentrate on other critical components of your development program. CMC Biologics’ CHEF1® Expression Platform and well-developed antibody production platform enables rapid and seamless process transfer to cGMP manufacturing.  We have the innovation to manufacture 500g of your IgG monoclonal antibody in a short amount of time, and within budget.

Click here to learn more about 2.012 (PDF).

MICROBIAL CELL PRODUCTION

QC_Lab_General_062_crop.jpgCMC Biologics is one of only a few CDMOs that have extensive expertise with microbial manufacturing using both bacterial and yeast fed-batch processes.

We have successfully expressed antibody fragments, growth factors, antigens, enzymes and other proteins using multiple modes of expression—including secretion (yeast), periplasmic secretion, soluble intracellular expression, and inclusion bodies.

We optimize media, feeds and standard processes for high cell density E. coli and P. pastoris production.


Our microbial cGMP manufacturing capabilities include:

  • cGMP manufacturing in 1500L stainless steel fermenters
  • Batch and fed-batch
  • Methanol feeding
  • Oxygen enrichment
  • Continuous centrifugation
  • High pressure homogenization
  • Secreted proteins and inclusion bodies
  • Manufacture of 3000L batches (combined 1500L fermenters)