2008

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…

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…

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…

CMOs Can Add Value to Outsourced Projects

Organizations outsource tasks to contract service providers for diverse reasons ranging from internal resource constraints (particularly in virtual or start-up companies) to overflow capacity, or to avoid or delay capital or resource investment. The scope of outsourced work varies from limited tasks such as an outsourced assay to complete process development and GMP manufacturing. In a highly competitive outsourcing market, customers expect successful and timely execution of the outsourced work, but they also seek “added value” to the overall program.…

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…

Cellular Therapy Success Through Integrated Automation

Cell therapies are being developed for a rapidly expanding range of indications. Genzyme Corporation has a treatment of cartilage in joints in long-term follow-up stage (Genzyme Corporation, www.genzyme.com). Cell Therapies are being investigated successfully in applications to treat infectious diseases such as AIDS, repair spinal cord injuries, strengthen immune systems, and treat neurological disorders such as Alzheimer’s disease, Parkinson’s disease, and epilepsy. Positive results have been reported in treating arteriosclerosis and other cardiovascular diseases, congenital defects, breast reconstruction, and liver…

How to Improve Your Implementation of Two-Dimensional Preparative HPLC

The biologics and natural product industries rely heavily on separation technology. Sample analyses are undertaken on the analytical scale, and isolation and purification are undertaken at the preparative scale. Key target components are often isolated to provide standard reference materials for future product quality assurance testing. These products are often very complex mixtures, requiring separation systems to have a high peak capacity for both analytical and preparative scale separations. A technique gaining popularity among companies that require the isolation of…

Biomanufacturing Capacity Use Showed Solid Performance in 2007

It appears that it will take more than just the subprime mortgage crisis to put a dent in biopharmaceutical manufacturing. Based on results of our latest annual report, capacity use in 2007 remained essentially steady for mammalian cell culture: at nearly two-thirds, 63.3% compared with 63.9% the year before (1). Capacity use represents the percentage of an industry’s production capacity that is actually in use. It measures how effectively manufacturers and industries are making use of their fixed assets. This…