Monday, February 13, 2017 Daily Archives

Introduction: Process Issues in Cell, Gene, and Tissue Therapies

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It’s hard to believe that just six years ago, BioProcess International published its first cell therapy supplement, which included just one article on “cell therapy bioprocessing†(1). At the time, most such processing was conducted in special clinical laboratories and academic institutions. As BPI continued to cover this relatively new segment of the biopharmaceutical industry, we heard more about “the product is the process†and “scale out instead of scaling up.†After many trials, errors, and milestones, regenerative medicine has…

February 13, 2017

Growth Projections for the Regenerative Medicine Market

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One of the fastest growing medical markets with great potential, regenerative medicine treats chronic diseases that were once untreatable. Therapy using live cells is increasingly used to replace damaged tissue, deliver gene therapies to target tissues and organs, and stimulate self-healing along with a number of other applications. View the full article below – Login Required Reference 1 Regenerative Medicines Market: Global Opportunity Analysis and Industry Forecast, 2015–2022. Allied Market Research: Pune,Maharashtra, India: August 2016; www.alliedmarketresearch.com/regenerative-medicines-market. 2 Chartrain NA, Williams…

February 13, 2017

Expansion Platform Components

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I first met Chris Mach at the Biotech Week Boston conference in October. We discussed the challenges that biomanufacturers are facing in cell expansion, especially in three specific areas in scale-up systems. View the full article below – Login Required

February 13, 2017

Platform Solutions for Cell Therapy Manufacturing

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Advances in cell therapy have resulted in significant progress toward treating some widespread and difficult diseases, many of which represent unmet medical needs. For example, phase 3 clinical trials are already under way for therapies based on mesenchymal stem cells (MSCs), including therapies for graft-versus-host disease, acute myocardial ischemia, and chronic obstructive pulmonary disease (COPD) (1–3). Successful cell therapy treatments for such afflictions will be not only significant medical breakthroughs, but also in very high demand. However, their commercialization is…

February 13, 2017

Scalable Purification of Viral Vectors for Gene Therapy: An Appraisal of Downstream Processing Approaches

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Gene therapy is the transfer of genetic material to a patient’s cells to achieve a therapeutic effect. Therapeutic DNA is largely delivered using viral vector systems based on adenoviruses (Ad), adenoassociated viruses (AAV), and lentiviruses (LV). With the application of such viral vectors as clinical therapeutics growing, scalable commercial processes (particularly for purification) are being investigated and optimized to best ensure that critical quality attributes (CQAs) are retained. Herein we review viral vector purification techniques and the effect of different…

February 13, 2017

3D Bioprinting Possibilities and Challenges

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Three-dimensional (3D) bioprinting is the newest addition to the regenerative medicine family. Now within the industry dedicated to providing more personalized drug products, this new additive-manufacturing technology has the potential to truly focus on individual tissue repair and replacement. In a short period of time, 3D bioprinting has been applied in studies using bones, blood vessels, composite tissues, vascular grafts, tracheal splints, cartilaginous structures, heart tissue (e.g., two-valve heart), and vaginal organs (1). View the full article below – Login…

February 13, 2017

February From the Editor

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The real word twitterpated (meaning infatuated or obsessed, in a state of nervous excitement) apparently was coined in Disney’s Bambi movie. Use of the word has increased over the past five or six years, achieving a new relevance. Now it can mean Twitter-headed, and I am finally beginning to catch on to the role that tweeting plays, for good and ill. As expected from a Hollywood word, it focuses our attention on the ephemeral, the superficial glitz of a person…

February 13, 2017

Spotlight for February 2017

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Introducing New Editorial Advisor Jason Condon is a senior CMC project manager at Vaccinex, Inc., in Rochester, NY as well as an assistant adjunct professor in biomedical engineering at the University of Rochester. He has held roles in biopharmaceutical manufacturing and process development at Bristol Myers Squibb and Janssen R&D. His expertise in cell culture and current good manufacturing practice (CGMP) manufacturing has contributed to developing manufacturing processes for monoclonal antibody (MAb), cell therapy, and vaccine production throughout his 13-year…

February 13, 2017

BioPhorum Operations Group Technology Roadmapping, Part 2: Efficiency, Modularity, and Flexibility As Hallmarks for Future Key Technologies

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For a complex biopharmaceutical industry, setting out to forecast future technologies must involve considering how such technologies will be used. In the first article (1), I discussed why there was a need to develop a technology roadmap for the biopharmaceutical industry and the trends shaping its future: namely, the introduction of new product classes, the continued growth of the biopharmaceutical market, pressure to reduce costs, and uncertainty in approval and sales of new products. Herein I discuss the technology roadmap’s…

February 13, 2017

Buffers in Biologics Manufacturing

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Biotechnology has enabled commercialization of protein-based drugs including insulin, growth factors, blood factors, and antibodies. Production and purification of such biologic products require different buffers for pH control and stabilization of reactions in different steps during biomanufacture. These processes include cell culture production (the “upstream†phase), purification (the “downstream†phase), and a final phase in which excipients are introduced to the drug substance to create a drug product (“formulation and storageâ€). In upstream processes, buffers are primarily used for their…

February 13, 2017