Evolving Media Needs
Although animal serum has long been a key agent for growing cells in culture, customers now desire serum-free media. The demand is driven by regulatory concerns about prions or other contaminants in media used to manufacture Mabs or vaccine antigens for human use.
Serum consists of a complex mixture of biological components, such as peptides, growth factors, and cytokines. Along with the company’s knowledge and experience of media, analytical tools help to characterize serum. The challenge lies in combining key components to optimize cell culture growth and expression of proteins.
“There’s no one way to replace serum,” says Bruce Lehr, director of marketing. To help customers make the switch, the company offers a library of media that are free of animal components to match customer needs. Even established cell lines change and need new nutrients to tweak protein expression.
A custom formulation manufacturing service, called imMEDIAte Advantage™, quickly manufactures liquid or powder media formulations for customers in about 10 working days. Performed at the customer’s site, imMEDIAte Advantage gives many variations of media for testing and evaluation. The fast turnaround reduces process development timelines.
A huge bottleneck in the development of biologics is selecting cell clones that generate high levels of product. SAFC Biosciences licensed exclusively a select application of LEAP, or laser-enabled analysis and processing, a high-throughput platform that rapidly isolates high-titer cell lines.
LEAP scans cell samples in 384-well microplates coated with an antibody to detect the target protein in 10 minutes. Each well of a plate contains up to 5,000 cells. An algorithm calculates the amount of product secreted and selects the best clone from among millions of cells. Moreover, the laser capability of the LEAP instrument can be tuned to kill all but one cell in a well, ensuring a single cell clone for further expansion and development. LEAP also serves as a microscope to view the growth of clones or cell size and morphology.
“LEAP statistically increases the chance of finding high-producing clones and offers tremendous time and labor savings,” says Kevin Kayser, manager of cell sciences and development at the company’s Life Sciences & High Technology Center in St. Louis, MO.
Within biopharmaceutical development, clone selection remains a tedious manual task lasting a year or more, which LEAP performs in only six months. In the classic process, clones that look promising are diluted so that only one is plated per well, then expanded to test for productivity. “We reverse that order and look for productivity before we expand the clone, so everything selected by LEAP is productive,” Lehr says.
SAFC Biosciences markets the service as Cell Xpress™. In addition to selecting stable clones, the Cell Xpress service formulates media to speed the production of biologics. “We screen the clones with our media to evaluate how productivity increases to find the right media,” says Matt Caple, director of R&D. Customers are spared the long media development process.