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…
Manufacturing
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…
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…
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…
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…
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…
Optimizing Vaccine Supply Chains Through Quality Management in Manufacturing
The recent product recalls of PedvaxHib and Comvax vaccine batches are a reminder that the control of vaccine manufacturing processes is of the highest importance. This rings especially true because the target population for these two products is children under the age of five. The Hib vaccine guards against meningitis and other serious infections caused by the bacterium Haemophilus influenzae. In this particular recall, type b vaccine was tested and determined to be free of contaminating microorganisms before being released…
Global Vaccine Commercialization
Defining the optimal market entry strategy for a vaccine is challenging. Worldwide, vaccine markets are commoditized andvery heterogeneous. In addition, with growth and evolving technology, the business model in the vaccines sector is changing. From the traditional vaccine model, constituted mainly of pediatric vaccines used to prevent a well-known series of viral and bacterial infections in large cohorts of healthy patients, we are seeing the emergence of a more pharma-like model that has been stimulated by new technologies, innovation, and…
The Next Generation of Biologicals and Their Production Systems
Combined advances in molecular biology, cell biology, and genomics have led to a wealth of new information about cellular processes. A growing understanding of the fundamentals of cell biology is now being translated into products that use an approach to exert a biological effect that is different from that of most biologicals currently on the market. To date, most biological products consist of highly purified proteins with a specific activity that alleviates or stops the symptoms of a certain condition.…