November 2008

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,…

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…

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…

Introducing Disposable Systems into Biomanufacturing

Single-use (disposable) systems are being considered and introduced into many biopharmaceutical processes because manufacturers have identified significant benefits they offer over traditional reusable systems. These benefits are often more evident when a new process and product are being developed. Lower capital expenditures, shorter development times for new facilities, and reduced validation costs are some of the reasons single-use technology may be selected. Here, a contract manufacturer’s case study is described in which an existing stainless steel system was completely replaced…

How to Justify Investment in Anticounterfeiting

Pharmaceutical products are critical to the social, economic, and political stability of societies around the world. No other business sector is more dependent on consumer confidence. Like food products, drugs are highly vulnerable to deliberate and/or accidental disruption. A small tablet has almost no intrinsic value on its own; its value derives from the pedigree of its manufacturer and the belief that the pill will change someone’s life for the better. Manufacturers hold a sacred trust (given them by their…

Partnering with a CMO in China

Many biopharmaceutical companies are evaluating the option of working with contract manufacturing organizations (CMOs) in China. There are probably as many reasons for following that strategy as there are companies doing the evaluating. However, regardless of the strategic plan behind pursuit of a CMO in China, there are key issues each company must consider as part of its due diligence before selecting one. Through a fast growing economy and government supported transition from low-margin to high-margin products, China is quickly…

Assessing Nonparallelism in Bioassays

The classic F-test for nonparallelism is widely used for bioassays with linear log dose-response lines to assess parallelism, or, more correctly, to examine the strength of evidence against a null hypothesis that the two lines are parallel. Alternative methods for assessing parallelism have been proposed, but their suitability for any particular case needs to be carefully considered. Here we examine some advantages and disadvantages of the different approaches. PRODUCT FOCUS: ALL BIOLOGICALSPROCESS FOCUS: QA/QCWHO SHOULD READ: QA/QC, ASSAY DEVELOPMENT, AND…