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CMC Strategy Forum Special Focus Series: Part 2 Product-Related Impurities,...
Introduction by Cheryl Scott The CMC Strategy Forums focus on relevant chemistry, manufacturing, and controls (CMC) issues throughout the life cycle of a therapeutic and thereby foster collaborative...
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Achieving Competitive Advantage in the Biopharmaceutical Industry
WWW.GRAPHICSTOCK.COM REPRINT WITH PERMISSION Drug development is a complex process that is associated with high drug-candidate attrition rates, long development times, and high costs (1, 2). Drug...
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Collaboration Will Drive Regenerative Medicine: Toronto Development Center...
Xuri cell culture media are formulated for the growth and expansion of human mesenchymal stem cells after their isolation from a number of sources. With support from the federal government of Canada,...
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Automation of CAR-T Cell Adoptive Immunotherapy Bioprocessing: Technology...
Continued clinical efficacy demonstrations of cell-based immunotherapies (iTx) such as chimeric antigen receptor T cell (CAR-T) therapies has made the prospect increasingly likely of an immunotherapy...
View ArticleA Turning Point for US Biosimilars
The next 12–18 months could be a critical time for biosimilars in the United States (1). This product class has grown rapidly since passage of the Biosimilars Price Competition and Innovation Act...
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Future Manufacturing Strategies for Biosimilars
WWW.GRAPHICSTOCK.COM REPRINT WITH PERMISSION Biosimilars are a relatively new subset of biopharmaceuticals, with the biotechnology industry finally maturing such that off-patent generic-type products...
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From CMO to CDMO: Opportunities for Specializing and Innovation
WWW.GRAPHICSTOCK.COM Biopharmaceutical contract manufacturing organizations (CMOs) were initially enabled when the requirement for a company to file for both an establishment license application and a...
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Quality By Design for Monoclonal Antibodies, Part 1: Establishing the...
The quality by design (QbD) modernized approach to pharmaceutical development is intended to provide regulatory flexibility, increased development and manufacturing efficiency, and greater room to...
View ArticleRegulating Quality in Continuous Processing
Regardless of the industry and product being manufactured, continuous processing has demonstrated numerous benefits. In addition to smaller manufacturing footprints, reduced material consumption and...
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Science, Risks, and Regulations: Current Perspectives on Host Cell Protein...
JUPITER IMAGES (WWW.THINKSTOCKPHOTOS.COM) State-of-the-art analytics guide process development by providing companies with thorough understanding, effective removal, suitable control, and comparability...
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Quality By Design for Monoclonal Antibodies, Part 2: Process Design Space and...
Figure 1: A design space plot as determined by Jiang et al. for a hydrophobic-interaction chromatography (HIC) step used to purify an Fc fusion protein (4). This example shows the acceptable design...
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Standardized Economic Cost Modeling for Next-Generation MAb Production
Figure 1: Biosolve Process cost of goods (CoG) and net present value (NPV) model configuration Historically, in generating material for clinical testing during antibody process development, emphasis...
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Managing Customer and Regulatory Expectations
Patheon’s facility in Greenville, NC Partnering with a contract development and manufacturing organization (CDMO) allows drug-product sponsors to turn fixed costs into variable costs. Market...
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Addressing the Challenges of Developing Biopharmaceutical Drugs
Stefan Schlack (Photo by Connect Upstream) The biopharmaceutical industry is enjoying considerable success. Its products account for about a fifth of world pharmaceutical revenues, which are growing at...
View ArticleCollaboration Is Key to Innovation in Biotechnology
A new report from Thomson Reuters shows that innovation in biotechnology declined slightly in 2015, and biotech is the only one of a dozen worldwide industries examined to show that kind of decline...
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Viral Risk Evaluation of Raw Materials Used in Biopharmaceutical Production
Figure 1: Raw materials high-level classification Ensuring a continuous supply of safe medicines to patients is a key objective for both health authorities and the pharmaceutical industry. A critical...
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Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit...
Figure 1: Immunoglobulin G (IgG) structure consists of four polypeptide chains, including two identical light chains (~25 kDa) and two identical heavy chains (~50 kDa). Each light chain consists of one...
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Designing the Optimal Manufacturing Strategy for an Adherent Allogeneic Cell...
Figure 1: Recommended range of manufacturing lot sizes across different demands. Vertical axis shows examples of different demands. For each level of demand, the horizontal bars show the range of...
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Manufacturing Plasmid DNA: Ensuring Adequate Supplies for Gene and Cell...
Figure 1: Manufacturing overview for viral vectors and modified T cells; MCB = master cell bank The concept of gene therapy is far from new, with initial studies performed over 20 years ago (1)....
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Progress Toward Commercial Scale and Efficiency in Cell Therapy Bioprocessing
ADOBE STOCK (HTTP://STOCK.ADOBE.COM) Regenerative medicine includes both cell and gene therapies. Currently 672 regenerative medicine companies operate around the world, and 20 products have been...
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