Biopharmaceutials and the processes used to make them are exceedingly complex, and the path to developing new therapeutics is a high-risk endeavor. The emphasis today is on controlling product quality, safety, and efficacy through understanding biological mechanisms, key product attributes, and process parameters. Such information is also crucial for guiding development efforts to improve chances of success in the clinic and for gaining regulatory approval. Analytical methods provide the foundation for acquiring such knowledge. Efforts devoted to developing meaningful and…
Business
2008 in Review
As the Chinese calendar warned us, it did indeed turn out to be a year of the rat. If you‘re in any doubt about the economic crisis of 2008, here’s a single significant indicator: Pharmaceutical companies’ spending on advertising declined this year for the first time in history. Walgreen’s CEO Jeffrey Rein was quoted in FierceBiotech as calling 2008 “the tightest market for prescription drugs” in his 27-year career. If big pharma and big retail were feeling the pain, of…
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…
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…
Critical Issues in Outsourcing to a CMO
Deciding to outsource biopharmaceutical manufacturing is a strategic decision with long-term consequences. Most companies deliberate carefully as they select a contract manufacturing organization (CMO). Because the factors involved in such deliberations vary widely among organizations — and they shift over time — my company has included an analysis of critical outsourcing issues as part of its fifth annual report and survey of biopharmaceutical manufacturing capacity and production (1). In this year’s study of 434 global biomanufacturing facilities, we found the…
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…
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…
Manufacturing Patient-Specific Cell Therapy Products
Several cellular therapies are currently progressing through clinical development with the potential to address unmet medical needs affecting millions of patients. As cell-based therapeutics receive regulatory approval and reach the market, the primary challenge will quickly become manufacturing such products in sufficient volume to meet demand. Aastrom Biosciences has developed tissue-repair cell (TRC) technology for use in autologous, patient-specific cellular therapy (PSCT) and is conducting late-stage clinical trials both in the United States and Europe. TRCs are derived from a…
The Orphan Drug Program
It’s been a quarter-century since the Orphan Drug Act became law in 1983. An orphan drug is any therapeutic, vaccine, or blood product that treats a rare disease or condition (one with fewer than 200,000 US patients). Such drugs may be new products or those already approved for other diseases but discovered to treat a rare disease. Drug sponsors must apply for orphan drug designation through the US FDA (1). Similiar status may be obtained in Europe through the EMEA’s…