Most products in discovery by pharmaceutical companies today are biopharmaceuticals. Made by living organisms, these are typically large–molecular-weight products that rely on their secondary and tertiary structure for therapeutic effectiveness. Synthetic small molecules and biopharmaceuticals both require analytical verification for release, but only biopharmaceuticals require functional potency assays for investigational new drug (IND), biological license application (BLA), and new drug application (NDA) submissions. Those activities often require elaborate transfers of diverse, biological, product specific assays that carry greater chances of…
Manufacturing Contract Services
Selection and Oversight of Domestic and International CMOs
Contract manufacturing is essential for early development of products by companies of all sizes, and it plays an important role in later production and testing. Product development is a complex process requiring manufacturing, optimization, and testing of candidate drugs, devices, combination products, and biologicals even before they ever reach the clinic. Contract manufacturing organizations (CMOs) provide services ranging from early product development and lead-candidate screening to process development, product manufacture, and testing. Outsourcing of development, manufacturing, testing, preclinical, and clinical…
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.…
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…
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…