Lonza and BioWa BioWa, Inc. and Lonza today announced that they have entered into a licensing agreement with MedImmune, the global biologics research and development arm of AstraZeneca. MedImmune has licensed the companies’ POTELLIGENT® CHOK1SV Cell Line Technology for use in multiple proprietary antibodies in its pipeline. POTELLIGENT® CHOK1SV is a host cell line for manufacturing recombinant antibodies that combines the power of BioWa’s engineered glycosylation POTELLIGENT® Technology with the advantages of Lonza’s industry leading GS Gene Expression Systemâ„¢. The…
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An Analysis of the US Biosimilars Development Pipeline and Likely Market Evolution
No consensus concerning biosimilar-related terminology and definitions has yet been achieved (1,2,3). Biosimilars may be defined as biopharmaceuticals slated for generic-drug–like, abbreviated, comparisons-based approvals through a formal biosimilar approval pathway in the United States, European Union, and/or other highly regulated and developed countries based on a demonstration of substantial (bio)similarity to a reference product. As required in the United States, biosimilar active agents (those involving recombinant proteins) must be identical in primary sequence with their reference products. Analytical and comparative…
Legacies in Bioprocessing
Bioprocessing is full of legacies. Our remote ancestors discovered fermentation: microbial magic that transformed fruit to wine and grain to beer. Building on the work of Edward Jenner and others, Edward Ballard systematically reinfected cattle to make vaccines. Louis Pasteur revolutionized both fermentation and vaccination by showing that different microbes caused fermentation and spoilage (saving wine and beer production from disastrous batch contamination), establishing the germ theory of disease, and using that knowledge to develop new vaccines against endemic infections.…
A Decade of Product Development
In 2004, the United States Food and Drug Administration (FDA) transferred regulation of many highly purified, “well-characterized†biopharmaceutical proteins from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER), which until then had primarily regulated only synthetic, small-molecule drugs and chemical substances. The most novel/complex and the less-characterized biologics remained within CBER’s jurisdiction. This change complicated BPI’s mission somewhat. When the magazine was founded, we responded to questions from advertisers…
Informatics Technologies in an Evolving R&D Landscape
Over the years, bioprocessing companies have leveraged a host of information technology (IT) to help them bring innovative new therapies to market. As the needs of a research and development (R&D) enterprise evolve, however, are such systems and applications a help or a hindrance? On one hand, the increasing sophistication of IT solutions — such as those designed to help users create advanced molecular models or track thousands of compounds through the discovery process — have enabled new…
Bioreactor Design and Bioprocess Controls for Industrialized Cell Processing
It’s official: The “Age of Cell Therapy” has arrived. A robust pipeline of cell therapies, with increasing numbers of both early- and late-stage clinical trials as well as FDA-approved commercial products that have entered the market already, strongly indicates that the cell therapy industry is poised to emerge as a distinct healthcare sector (1). Renewed investor interest and recent activity among major pharmaceutical companies suggest that this industry will rapidly develop the capability and capacity to be a highly competitive,…
From the Publisher and Editor
At about this time of the year, 10 years ago, the four founders of BioProcess International were in arguably the most creative period of their lives. By the middle of 2002, we began designing our collaborative production and operating processes with our new Informa colleagues (then Eaton Publishing). We were assembling author and advertising contacts pretty much from scratch, trading opinions about page designs, building a manuscript pipeline, choosing fonts (something those outside of publishing might not…
An Emerging Answer to the Downstream Bottleneck
Biotechnology companies have invested billions of US dollars in new manufacturing infrastructure, expanding the industry’s total mammalian cell culture production capacity from 670,000 L in 2002 to 2,550,000 L in 2010 (Figure 1) (1). This capacity expansion is estimated to have cost the industry about $20 billion (Figure 2) (1). Figure 1: Macroporous structure of Natrix chromatography media (see () Figure 1: () Figure 2: () That production capacity (and the investment it represents) is…
Scaling Up Stem Cells
Cell-based products are becoming increasingly important as potential biotherapies. Cell therapy is predicted to have a huge impact on the healthcare sector over the coming decades. Stem cells, in particular, are investigated as potential treatments for a diverse range of applications (such as heart disease and metabolic and inflammatory disorders) in which they might be used to restore lost biological functions. The cell therapy industry is starting to mature. Several emerging companies are now supporting late-stage clinical trials,…
India
India is well known as a key destination for bioprocess outsourcing and a major supplier of active pharmaceutical ingredients and raw materials. The global pharmaceuticals manufacturing outsourcing industry is expected to reach US$100 billion by 2015 (1). India has the potential to capture 8–10% of this industry by 2015 and become one of the top 10 global markets by value (2). By comparison, India’s biotechnology industry (consisting of biopharmaceuticals as well as other sectors) has gained global attention…