Regulations and common sense require that a manufacturer qualify both the raw materials and the suppliers the firm will use to produce GMP supplies of a pharmaceutical or biopharmaceutical. Because the firm is accepting legal liability for the quality of all raw materials, it makes good business sense to devote resources to these activities. This article explores how to assure that qualification is complete, efficient, and compliant with current good manufacturing practice (cGMP), and discusses the challenges faced by today’s manufacturers…
BioProcessing Journal Posts
Proteins and their promise for revolutionizing drug discovery have come virtually full circle in just a few decades. The advent of genetic engineering and the emergence of early recombinant proteins such as insulin and interferon dramatically boosted the perceived value of proteins in pharmaceutical research and of protein drugs in particular. Although the lights dimmed somewhat on the promise of therapeutic proteins in subsequent years, more recent times have seen a resurgence of interest in proteins, particularly monoclonal antibodies. Perhaps most telling has been the dawn of the post-genomic era, which has cast a bright spotlight on proteins, long respected as the work-horses of the cell, for their usefulness in exploring cell function, unraveling biochemical pathways, understanding disease, and for their massive value as novel drug targets…
Several developing countries, including India and China, have young biopharmaceutical industries that have based much of their growth potential on the production of what are currently known as “biogeneric” products, or “bioequivalent” versions of biologics that have already been licensed in Western countries. With a disdain for foreign patents, an established philosophy of copying Western innovations, and success in generic pharmaceutical manufacturing, this approach appeared to be the logical way to build a biologic manufacturing industry. However, there are numerous problems with this development strategy. First and foremost is the inherent incompatability of the very concepts associated with biogeneric products…
From an intellectual property (IP) standpoint, probably the two biggest problems I encounter in my practice for early-to-middle stage technology companies are: (1) their failure to fully understand and keep abreast of the competitive intellectual property environment , and (2) their failure to institute procedures that will permit and encourage development of a strategic intellectual property portfolio. By “strategic,” I mean an intellectual property portfolio that focuses on both an offensive and defensive position — a portfolio that not only covers the product and all aspects of its manufacture, production, and applications (defensive portfolio development), but also provides significant blocking positions with respect to competitors’ efforts…
A growing number of separations’ scientists and process developers are looking beyond protein A sorbents for capture and initial purification of monoclonal antibodies. A variety of strategic and operational goals have prompted examination of alternative immunoglobulin-selective sorbents. Most broadly, many workers wish to eliminate design considerations associated with leached protein A. Also cited is a preference for sorbents that can withstand stringent cleanup using 1 M sodium hydroxide. In some applications, it is desirable to avoid the low-pH elution conditions typically employed with protein A sorbents — conditions that can foster aggregate formation. In still other cases, the target antibody may bind poorly to protein A. Finally, there may be interest in evaluation of immunoglobulin-selective sorbents less costly than protein A sorbents…
The United States Pharmacopeia (USP) is a 184-year-old organization that has been in the forefront of technology since its inception. From publishing a manual about how to prepare therapeutic potions, USP has evolved into a compendium of standards and information on manufactured pharmaceutical products, with more than 4,000 monographs covering drug substances and biologics, and their dosage forms, excipients, and nutritional supplements. It is not surprising that the USP initiative in cell and gene therapy and tissue engineering has closely followed the emergence of these technologies…