By Erin Yeh and Qinghai Zhao (Purification Group), Joseph Bordas-Nagy (Protein Characterization Group), Ping Feng (Analytical Group), TEVA Biopharmaceuticals
Biosimilar, a term synonymous to "follow-on biologic," requires very stringent and high standards of comparability with the original biologic drug that is being replicated. Unlike conventional small molecules and chemical generics, "biogenerics," or biosimilars, especially monoclonal antibodies, have complex structures and functions that are affected by slight changes in the manufacturing process.
By Tony Harrison, UK Subject Matter Expert to ISO Technical Committee 209 Working Group
The intensely manual practices of cleanroom classification and routine monitoring are time-consuming and prone to data errors. Particle counter performance and accuracy can vary widely, leading to inaccurate particle counting data.
By Dr. Kevin Ward, Biopharma Technology Limited
The FDA defines a generic drug as "a drug product that is comparable to a brand-listed drug product in dosage form, strength, route of administration, quality and performance characteristics and intended use."
By Brad Larson and Peter Banks, Applications Department, BioTek Instruments, Inc.; and Nicky Slawny, 3D Biomatrix, Inc.
Scientists using cell cultures for drug discovery, toxicology, stem cell biology, and basic research realize the critical importance of 3-dimensional (3D) models. Data from cells cultured in a nonphysiologic, monolayer format on plastic surfaces has long been suspected to differ from true in vivo physiology, and there is mounting evidence that this difference is slowing the pace of scientific discovery.
Gain the insight and contacts you need to make your single-use platforms more efficient, economical, and meet more complex drug demands at IBC's 11th Single-Use Applications for Biopharmaceutical Manufacturing conference, taking place June 9 and 10, 2014, in Boston, MA.
Bioresearch Online readers can save 20 percent off the standard rate with priority code B14187BIO20 during online registration at http://bit.ly/1jHaZ86.