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…
November 2008
Technologies and Training Move Sterility to New Levels
Take six people and sample the microbial ecosystem on their forearms, and you will find more than 240 distinct microbes (1, 2). So it becomes readily apparent why keeping a cleanroom “clean” is a difficult task. One problem is that we humans are limited in our visual capacities and can see objects down to only 50 µm (3). If we could see contaminating particles, we would likely be very quick to clean them away. In fact, cleaning and cleaning validation…
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.…
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…
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…
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…
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…