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Recent Advances for Rapid Development of High-Quality, Robust Mammalian Cell Culture

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Jozef Orpiszewski (senior director of program design, Fujifilm Diosynth Biotechnology), BPI Theater @ BIO, June 7, 2016, 11:20–11:40 am Fujifilm Diosynth Biotechnology is focused on accelerating bioprocesses from gene to finished products by shortening the time line, all while following quality by design (QbD) precepts and making processes as robust as possible. When this CMO started several years ago, the development time line was about 18–24 months. Using new tools, approaches, and innovations, the company has shortened that time to…

August 11, 2016

Continuous Disposable Multicolumn Chromatography: Emerging Technology to Enable More Efficient Clinical Downstream Processing

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John Moscariello (vice president of process development,CMC Biologics) BPI Theater @ BIO, June 7, 2016, 11:40 am – 12:00 pm Most recent innovations improving efficiency have been on the upstream side of biomanufacturing. On the downstream side, bottlenecks usually occur at the chromatography step. Chromatography is such a powerful tool in purification that bioprocessors simply cannot do without it. CMC Biologics is introducing multicolumn chromatography (MCC) to help solve this bottleneck. Batch chromatography involves a number of steps — equilibrate…

August 11, 2016

Optimizing Noninvasive Delivery of Biomolecules

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Julien Meissonnier (vice president of science and technology, Catalent), BPI Theater @ BIO, June 7, 2016, 2:00–2:20 pm The Catalent Applied Drug Delivery Institute (CADDI) is an organization that aims to improve comfort for patients and expand the use of advanced noninvasive delivery technologies. The institute was developed in 2012, when Catalent recognized a gap existing between academia and industry when it came to the science of noninvasive delivery. Through it, the company strives to foster the development of new…

August 11, 2016

Manufacturing for Chimeric Antigen Receptor (CAR) T-Cell and Gene Therapies

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Daniel Smith (chief scientific officer, Cobra Biologics) BPI Theater @ BIO, June 7, 2016, 1:40–2:00 pm Cobra Biologics has been active in gene therapies for 20 years. The company began by manufacturing plasmid DNA for use in gene therapy products. It rapidly moved into contract manufacturing and now has a broad offering of protein virus DNA, fill–finish services, wholesale vaccines, and biologics. Based in Europe, Cobra has a facility in the United Kingdom specializing in microbial plasmid production and viral…

August 11, 2016

Comprehensive Hands-On Training for Biopharmaceutical Manufacturing

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Nathaniel Hentz (assistant director of the analytical laboratory at BTEC) BPI Theater @ BIO, June 7, 2016, 2:20–2:40 pm The Biomanufacturing Training and Education Center (BTEC) is part of the College of Engineering at North Carolina State University. In addition to training students and employees in the bioprocess industry, it also provides training for investigators with the US Food and Drug Administration (FDA). BTEC can demonstrate an entire process through upstream production, downstream processing, and drug-product filling in its manufacturing…

August 11, 2016

Go Beyond: A Review of Tomorrow’s Biopharma Landscape from the Emerging Biotech Perspective

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Ruta Waghmare (director of worldwide emerging biotech market sales development in global pharma processing, Millipore Sigma), BPI Theater @ BIO, June 8, 2016 11:00–11:20 am Millipore Sigma recently surveyed emerging biotechnology companies, defining those as companies with US$500 million or less in annual revenues. Such companies reported that one of their greatest challenges is attracting investors despite a rise in venture financing. In North America, the amount of funds involved in each financing round has increased, but the number of…

August 11, 2016

Challenges in the Development of Biologic Drug Products

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Hanns-Christian Mahler (head of drug product services, Lonza), BPI Theater @ BIO, June 8, 2016 11:20–11:40 am A drug product transfers a biomolecule (drug substance) into a form that will be usable by patients. It contains the active ingredient with excipients and can include packaging or a device for administration. In many cases, patients must be able to administer drugs to themselves. “Think about how the drug will be administered before designing your formulation,†Mahler suggested. Keeping a biomolecule intact…

August 11, 2016

The Portrait of a Protein: Exposing Its Character with Advanced Analytics

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Greg Adams (director of analytical and formulation development, FUJIFILM Diosynth Biotechnologies), BPI Theater @ BIO, June 8, 2016 11:40 am –12:00 pm Fujifilm Diosynth Biotechnologies is a global contract development and manufacturing organization (CDMO) that has worked on multiple molecules. Adams said that proteins are complicated molecules with three dimensional (3-D) structures (primary, secondary, and tertiary) that are apt to self-aggregate. Monoclonal antibodies (MAbs), which we think of as relatively simple proteins, actually have very complex 3-D structures, with multiple…

August 11, 2016

Benefits to Strategic Outsourcing of Biologics Analytical Studies

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Michael Merges (director of Catalent Biologics), BPI Theater @ BIO, June 8, 2016, 1:40–2:00 pm Many small companies do not have the expertise or specialized technologies to do the necessary testing that underlies biologics manufacturing. Expertise is needed in microbiology, raw materials testing, characterization, and method development. At the same time, testing is taking place earlier in product development. Bioassays are the most outsourced service, and that is expected to continue. Catalent has over 25 years of experience in characterizing…

August 11, 2016

Insourcing, Outsourcing, and Everything in Between: Tough Questions, Real Answers, and How to Make the Correct Decision for Your Situation

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Greg Beattie (corporate vice president for global insourcing solutions and research support services, Charles River Laboratories), BPI Theater @ BIO June 8, 2016, 2:00–2:20 pm When you think of Charles River Laboratories,†Beattie began by asking, “do you associate it with anything other than rodents?†The company is very well known for selling rats and mice. However, it is also one of the world’s largest outsourcers in the biological testing field. The company is also one of the largest “insourcing 

August 11, 2016