November 2008

Comparing Mammalian Expression Systems

Almost every pharmaceutical and biopharmaceutical company in the world depends on the use of recombinant stable cell lines to enable drug discovery, development, and often manufacturing of biologics. It normally falls on multidisciplinary upstream development teams to attain this goal, requiring a wide variety of technologies and skill sets such as laboratory robotics, optical analyzers, molecular biology, and data processing. The large capital investment required to procure the equipment and expertise necessary to develop biologics can be cost prohibitive, which…

Maximizing Data Collection and Analysis During Preformulation of Biotherapeutic Proteins

Preformulation research, a critical component in the development of biotherapeutics, explores the effects of variables such as pH, ionic strength, and excipients on the solution behavior of a protein. This activity can greatly assist in guiding downstream formulation development, and it provides valuable information concerning protein stability, solubility, and structure. Successful preformulation research leads to identification of potential protein degradation pathways and development of robust formulations with acceptable product shelf-lives. PRODUCT FOCUS: PROTEINSPROCESS FOCUS: DOWNSTREAM PROCESSING, FORMULATIONWHO SHOULD READ: FORMULATIONS,…

Biopharmaceutical Quality Assurance

The basic concepts and reasons for quality assurance (QA) in biotechnology are, of course, the same as for the manufacture of any other medicinal product or device: to assure the safety of the patient. So, what’s different about biotechnology? The variety of products is vast — from well characterized proteins in production for the past couple of decades, to cell based products, genetically modified oncolytic viruses, viral gene vectors — and many more, with new innovations almost daily. Although their…

Novel Excipients Prevent Aggregation in Manufacturing and Formulation of Protein and Peptide Therapeutics

Protein and peptide therapeutics may undergo numerous physical and chemical changes during manufacturing, shipping, storage, and administration that can adversely alter drug potency and safety. Earlier concerns focused upon denaturation (unfolding), oxidation, and deamidation of certain key aminoacyl residues. Recently, aggregation has emerged as a key issue underlying multiple deleterious effects for peptide- or protein-based therapeutics, including loss of efficacy, altered pharmacokinetics, reduced stability and product shelf life, and induction of unwanted immunogenicity. As a result, the US FDA and…

Want a Good Partnership?

One evening, during dinner with several colleagues, the topic of company collaborations and contract organizations came up. I related my own experiences as party to a failed effort and the lessons I’d learned. As our conversation continued, our late night conclusions were simple: Effective partnerships are the means by which we achieve market success, but building such partnerships is complicated. One mistake after another can quickly cascade into a company’s collapse. Here I review six ways to ruin your company…

TFF Membranes for High MAb Concentration

In a typical monoclonal antibody (MAb) purification process, immediately after cell culture and supernatant clarification (its objective being to remove whole cells, cell debris, and particulates), the protein product is typically bound to an affinity chromatography resin and then recovered by elution using a buffer solution. Once recovered, the resulting protein solution is further purified through additional chromatography and virus clearance steps before being concentrated until a final solution is ready for filling and finishing operations. PRODUCT FOCUS: MONOCLONAL ANTIBODIESPROCESS…

Products, Services, and Literature

Stainless Steel Sanitary Fittings Product: Swagelok Sanitary Fittings Features: Offered in up to 12-in. diameters in a variety of configurations, Swagelok sanitary fittings are available to meet ASME-BPE and 3-A standards, as well as ISO 2852 requirements. They feature polished and unpolished inside- and outside-diameter surface finishes. Swagelok sanitary fittings are typically used in biopharmaceutical and food, beverage, and dairy process systems, such as water and fermentation. The vacuum annealed, cold form tubular fittings minimize the likelihood of stress corrosion…