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…
November 2008
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…
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,…
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…
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…
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…
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…
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…
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,…
Leveraging the Size and Scope of Global CROs
Biotech was “born” in the 1970s. Since that time innovation by biotech pioneers has brought more than 200 medicines and vaccines to fruition for difficult-to-treat indications including oncology, HIV/AIDs, diabetes, and immune disorders. Another 400 biotech products targeting 200 diseases are currently in clinical trials, and 700 compounds are in preclinical development (1). Overall, the industry had a banner year in 2007, with an 8% increase in biotech revenues and a total of more than $29.9 billion (US) in investment…