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…
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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…
Global Follow-On Biologics Conference
The future legal and regulatory pathway for follow-on biologic (FOB) products will be as complex as are protein products themselves. Questions range from how to be certain of the similarity, safety, and efficacy of follow-on products to what will be the key drivers for success in the future marketplace for follow-on biologics — and many more. As approval from the US legislature becomes a reality, innovator and FOB companies will prepare for the future by taking a proactive, not reactive,…
Puerto Rico Aims to Be the Biotech Island
Our vision is to be the preferred partner for industry and academia for biotech training, research, and development in the American hemisphere by 2012.” That’s the vision statement of the Bioprocess Development and Training Complex (BDTC) in Mayaguez, Puerto Rico, which opened 11 September 2008. The BDTC is the latest in a series of developments designed to make Puerto Rico “Bio Island,” the goal of Governor Anibal Acevedo-Vila. As he described in a conversation with BPI at the 2008 BIO…
The Genesis of New Production Tools for Biotechnology Manufacturers
The biotechnology industry has from the start been characterized by its dependence on innovation. New therapeutics, new indications, new technologies — and the continual drive toward new approaches for optimizing processes — all contribute to getting novel products to the market (and to patients) efficiently and cost-effectively. Most of the technical literature reports on development processes for the therapeutic products themselves. But one element largely ignored forms an essential foundation to the work of the biotechnology industry: How are products…
Managing the Analytical Life-Cycle for Biotechnology Products
The analytical program for a given biotherapeutic has a life-cycle analogous to that of a manufacturing process used to prepare material for clinical and commercial use. This two-part article discusses analytical activities associated with the progression of biotherapeutic candidates from the early stages of clinical development through their appearance as licensed drugs on the market. In Part One, we examined the stages of the analytical life-cycle. Here we conclude by going into more detail on challenges associated with method qualification,…
Optimizing Vaccine Supply Chains Through Quality Management in Manufacturing
The recent product recalls of PedvaxHib and Comvax vaccine batches are a reminder that the control of vaccine manufacturing processes is of the highest importance. This rings especially true because the target population for these two products is children under the age of five. The Hib vaccine guards against meningitis and other serious infections caused by the bacterium Haemophilus influenzae. In this particular recall, type b vaccine was tested and determined to be free of contaminating microorganisms before being released…