February 2012

Ten Years of Downstream Processing

About halfway through our first decade in publication, we became well acquainted with a new buzzword phrase in the biopharmaceutical industry: downstream bottleneck (1). This followed on the heels of a manufacturing capacity crunch that had been forecast shortly before BPI made its debut. Thanks to herculean efforts by upstream process and cell line engineers, that crunch didn’t pan out. In its place, however, high-titer production moved the pressure downstream. Now separation and purification engineers were tasked with handling concentrated…

Upstream Single-Use Bioprocessing Systems

Single-use bioprocessing equipment has become well-accepted technology in a relatively short time. Disposable devices and components have created market niches and new segments that continue to evolve. In this dynamic environment, it is difficult to measure acceptance or assess market growth. Here we project the world market for cell culture single-use systems (SUS) as well as problems affecting that market, including adoption for commercial manufacture. This is based on our 10-year analysis of the industry, with data from our eighth…

Success Stories from the Asia–Pacific

The Asia–Pacific region is a vast geographic area with a loose definition — covering East Asia, Southeast Asia, and Oceania. It includes a variety of cultures and races and is home to both developed and developing countries. Depending on the definitions of the region, the gross domestic product (GDP) varies from $500 per capita in East Timor to $41,500 in Australia, and the populations climb from a mere 55,500 in Australian Samoa to a vast 1.3 billion in China (1).…

Production of CGMP-Grade Lentiviral Vectors

Lentiviral vectors are important tools for gene transfer because of their ability to transduce a number of cell types without the need for host cells to be dividing (1, 2). As a result, investigators are using them as gene delivery vehicles in clinical applications (3,4,5,6). Although these vectors are used routinely in many research laboratories, large-scale production using current good manufacturing practice (CGMP) methods comes with a set of challenges that must be considered as more clinical trials using lentiviral…

Host Cellular Protein Quantification

Host-cell proteins (HCPs) are bioprocess-related impurities that may be present in intermediate or final biopharmaceutical products such as recombinant monoclonal antibodies (MAbs). Although the potential clinical and genetic effects of HCPs are largely unknown, studies have shown that HCPs may cause immune responses and adverse reactions in patients when present at sufficient high levels (1,2,3). Consequently, US Food and Drug Administration (FDA) and European Commission regulations require that the level of HCP in a bioproduct be quantitatively measured during manufacturing…

Ensuring Aseptic Processing Through Quality By Design

Assurance of sterility throughout drug manufacturing is paramount to patient safety. Drug products must be free of contamination from microbes, particulates, and chemicals. To that end, we see continued and increased regulatory scrutiny, with adoption of US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards outside the United States and the European Union. To consistently make microbe-free products, drug manufacturers must implement robust, validated processes that include sterilizing filtration. Sterilizing-grade filtration is used in a number of…

Global Marketplace

Biosensing Product: SpectroSens optical microchips Applications: Environmental monitoring and antibody detection Features: By using light to measure change, optical biosensors from Stratophase bring precision, flexibility, and cost-effectiveness to real-time monitoring and diagnostics. The SpectroSens microchip biodetector is coated with specific antibodies that bind with high specificity and affinity to biological targets. When a given toxin, bacteria, antibody, or virus is present in a sample, it binds and triggers a positive detection. One disposable microchip can be used to test multiple…

TIDES Oligonucleotide and Peptide Research, Technology, and Product Development

More therapeutic candidates are nearing approval, and the many classes of oligonucleotide therapeutics in development are creating great excitement. The peptide pipeline is vital, with candidates that could be blockbusters. To tap into this market and get the best information to move your program forward, there is no better place to meet than at TIDES. Manufacturers face tremendous pressure to keep drug costs down with uncertainty about regulatory expectations for analytics and GMP manufacturing issues. The industry needs to know…

Sustainabilty Is Good for Business

James Cerruti is senior partner of strategy and research for Brandlogic, a full-service brand consultancy that published in June its 2011 Sustainability Leadership Report: Measuring Perception vs. Reality in partnership with CRD Analytics. The report measured actual and perceived performance of environmental, social, and governance (ESG) factors for 100 major corporations. The report is based on a survey of key audiences who are considered to be “highly attentive” to ESG issues: investment professionals, purchasing and supply chain managers, and graduating…

From The Editor

One disadvantage of having covered this industry for so long is that we can get too used to terminology that is no longer quite adequate. This emerged in discussions with our advisors and readers throughout the creation of our anniversary awards program. For want of other available terms, BPI has (from the start) rotated issue themes of upstream, downstream, and “manufacturing” — that third category or “pillar” that encompasses filling and finishing and activities that occur throughout process and product…