November 22nd 2024
The company will now include GMP cell-based potency assays at its Cambridge, UK, and San Diego, Calif., sites expanding its early and late phase analytical capabilities.
Analytical Testing to Support Biopharmaceutical Products
April 2nd 2007A tremendous amount of analytical testing is required to support a biopharmaceutical product from discovery, development, and clinical trials, through manufacturing and marketing. Numerous methods are used to fully characterize large molecules because of their complexity-characterizing them is significantly more difficult than it is for small molecules. Biopharmaceuticals are produced via living systems, i.e., E. coli, yeast, or mammalian cells, which require additional testing matrices.