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Recombinant protein–based medicinal products and modern cell-based vaccines have a very strong safety history with respect to viral and microbial contamination. However, virus contamination incidents do occur occasionally in manufacturing processes, and they can consume many resources and be expensive to rectify. The root cause of contamination incidents in recent years is most likely the use of contaminated raw materials. These include bovine serum contaminated with reovirus, epizootic hemorrhagic disease virus, Cache valley virus or vesivirus 2117; porcine trypsin contaminated with porcine circovirus; and other media components contaminated with minute virus of mice (MVM). In those cases, no virus was detected through routine raw-materials screening because of limitations either in the sensitivity of assays used or in the amount of material screened. Components of some materials (such as antivirus antibodies that may be present in bovine serum) can also inhibit virus detection. Metagenomic techniques (s...
Membrane adsorbers (MAs) are the fastest-growing segment in single-use bioprocessing. But their future is not entirely certain. According to BioPlan Associates’ latest survey of biopharmaceutical manufacturing, the MA market has been growing at ~20% annually since 2006 ( 1 ). Paradoxically, however, the segment may not be a true “rising star.” Our study also shows that MAs remain among the least-often adopted devices among biomanufacturers. So the question of how and whether MA technology can revolutionize bioprocessing remains open. Market for Membrane Adsorbers The current market for membrane adsorbers in single-use and other bioprocess applications is in the US$30–40 million range. That does not represent a very large business segment. However, it is growing at ~20% annually according to our 10th annual report, a figure that has been confirmed by industry participants. The major MA providers are Sartorius Stedim Biotech SA (Sartobind) and Pall Corporation (Mustang-Q), each making up about a third of th...
The global annual revenue for biopharmaceuticals has been growing consistently since 2001, accounting for 15.6% of the total pharmaceutical market in 2011. The global biopharmaceutical market was valued at US$138 billion in 2011 and is expected to surpass $320 billion by 2020 ( 1 ). The market for recombinant proteins now exceeds $100 billion, a milestone attained in 2011. Figure 1:  () Much of the growth in biopharmaceutical revenue is due to an increasing number and sales of recombinant monoclonal antibodies (MAbs), now a $45 billion market — ~45% of the recombinant protein and ~31% of the overall biopharmaceutical market ( 2 ). Recombinant MAb sales will continue to increase rapidly in coming years as new products are approved. Many of the 5,408 medicines in development are in trials for more than one indication, so the total number of projects in development was close to 8,000 as of December 2011 ( 3 ). Figure 1 provides more detail. Figure 1:  () This rising prominence of biopharmaceuticals presents ...
Both the United States and the European Union have recently evolved guidance on how to execute process validation ( 1 , 2 ) with the prospect of a more appropriate life-cycle approach. It goes beyond the traditional three to five lots run at the center point of proposed ranges for operating parameters. New approaches leverage product design and process development information. They facilitate adapting the quality by design (QbD) paradigm to allow for a science- and risk-based selection of critical process parameters, key process indicators, and appropriate specification criteria. The number of runs for process performance qualification (PPQ) must be determined using a risk-based understanding and control of process variability. This approach allows for more comprehensive use of multiple data sources to strengthen process understanding. Once process performance qualification has been executed, a stage of continued process verification begins for ensuring that a qualified control strategy is sufficient and...
Like spectroscopy, as discussed in BPI Lab last month ( 1 ), cell signaling is not a laboratory technique but rather an area of scientific study. The environment of living cells — whether prokaryotic or eukaryotic, in vitro or in vivo — comprises not only water, nutrients, waste products, and metabolites, but also molecules released by other cells in response to intracellular events such as microbial infection and disease state or environmental factors such as temperature, osmolality, and pH. Receptor proteins on the surface of each cell pick up such molecules and react accordingly. Cellular reactions are transmitted through cell-signaling pathways from one location (exterior) to another (cytoplasm, nucleus), with numerous components forming signal-transduction cascades. They often involve series of reversible protein phosphorylation events catalyzed by protein kinase enzymes. Cell signal transduction thus forms the basis of growth and development, tissue repair, and immunity as well as normal homeostasis...
Protein A affinity chromatography has been a target for replacement since its commercial debut, mainly because of its high acquisition cost. The technique became established despite the cost because it was born into an industrial culture that favored speed to market over manufacturing economy ( 1 ). Vendors have since strengthened protein A’s position with incremental but worthy improvements such as higher capacity, lower ligand leaching, and modest tolerance of NaOH. Collateral improvements in polishing technologies, such as the high throughput and favorable economics of single-use membrane adsorbers, have helped reduce overall purification costs. Continuous chromatography systems promise to reduce chromatography media and buffer volume at the protein A step itself. Media price reduction from competition among protein A vendors must eventually have an impact as well. PRODUCT FOCUS: Proteins (antibodies) PROCESS FOCUS: DOWNSTREAM PROCESSING WHO SHOULDREAD: PROCESS DEVELOPMENT, ANALYTICAL, AND MANUFACTU...
GE Healthcare Life Sciences recently launched a joint program with Osaka University to support future growth of the biopharmaceutical sector in Japan. Together, they offer students access to GE Healthcare’s expertise in training and technologies for bioprocess research and manufacturing. The program is funded by Osaka University as part of its “Interdisciplinary Program for Biomedical Sciences” (IPBS), a government-funded commitment to graduate education. The goal of IPBS is to educate young scientists to undertake global-scale collaborations to develop effective treatments for intractable diseases during their future research careers. The program recruits partners not only from academia (graduate schools of medicine, pharmaceutical sciences, engineering, frontier biosciences, science, and dentistry), but also from industry. That allows students to engage with scientists in cutting-edge interdisciplinary research. Of the 14 recent IPBS graduate students, four were given the chance to visit GE Healthcare L...