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 variety is vast, all are incredibly complex, potentially difficult to define by analysis alone (with the exception of certain well characterized proteins), and highly potent. Additionally, “things” potentially can grow in the process stream releasing unknown metabolites, or on the product itself causing molecular abnormalities that you didn’t even know were possible, let alone how to test for.
Furthermore, most of these products cannot be terminally sterilized, some cannot be filter sterilized without dramat...
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.
Added value
can be defined as elements in addition to a contracted service that enhance the economic, scientific, environmental impact, or regulatory status of a project.
Key Concepts
Two key concepts in outsourcing biopharmaceutical development and manufacturing projects are project lifecycle and product lifecycle support. The former describes the evolution of a manufacturing process to deliver material for intended preclinical or clinical studies; the la...
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 has spurred growth of a service sector to provide timely, cost-effective protein expression solutions. The outsourcing industry has grown consistently, paralleling the development of therapeutic biologics and leading to a wide array of protein expression technologies.
The impact protein expression level has on production costs cannot be overemphasized. High expression levels translate directly to lower cost of goods because of lowered capitalizat...
+1Deciding 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 most important issue (as indicated by 43.6% of respondents) to be control of capacity, offering a secure supply of products (Figure 1). Following that were establishing a good working relationship and demonstrating a track record with similar products, as indicated by 41.4%, for each.
Figure 1:
Offering a Secure Supply
Clearly, control of capacity is an important issue, and it has continued to grow over the past three years from 32% to 44%. The ...
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 (
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). 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 capital raised in Europe and the Americas. Record levels of financing and deal making suggest strong confidence in this sector, with mergers, acquisitions, and alliances in the amounts of US$60 billion in the United States and $34 billion in Europe (
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).
Biotech is poised to capitalize on the current challenges confronting Big Pharma: looming patent expirations on blockbuster medicines and a dearth of new compounds in the pipeline to replace them. Current pharmaceutical business models a...
+2 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 expanding its pharmaceutical opportunities. There are 700 Chinese drug makers and 3,000 Chinese medical device companies registered with the FDA to market their products in the United State or sell them for further manufacturing. Drug imports from China to the United States have more than quadrupled in the past five years, and they exceeded $400 million in 2007 according to the International Trade Administration (part of the US Department of Commerce) (
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).
Although most Chines...
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 with outsourced providers — whether with a development partner, contract manufacturer, or clinical research organization — drawing on my own personal experiences with a biotechnology and medical device company. That company, after making all of these mistakes, one after the other, no longer exists today. As the case study unfolds, astute readers may wonder how the company managed to exist as long as it did despite compounding poor decisions with more poor decisions. So often, our decisions do not ...
