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BioProcess Insider Interviews Felix Hsu

For the on-demand virtual BPI Theater at the Biotechnology Innovation Organization’s annual convention, BioProcess Insider founding editor Dan Stanton conducted a series of interviews to discuss trends in biomanufacturing. Here, we summarize his conversations with Felix Hsu, chief commercial and chief business officer at WuXi Advanced Therapies. WuXi Advanced Therapies has served the cell and gene therapy industry as a contract development and manufacturing organization (CDMO) for nearly two decades. When speaking with BioProcess Insider’s Dan Stanton, Hsu reflected on…

BioProcess Insider Interviews Steve Burton

For the on-demand, virtual BPI Theater at the Biotechnology Innovation Organization’s annual convention, BioProcess Insider founding editor Dan Stanton conducted a series of interviews to discuss trends in biomanufacturing. Here, we summarize his conversation with Steve Burton, chief executive officer of Astrea Bioseparations. Astrea Bioseparations (formerly Prometic Bioseparations) is eager to expand in the wake of its acquisition by Gamma Biosciences, a platform for life-sciences tools and a subsidiary of KKR. Burton explained that before the acquisition, his company felt…

The Road to Commercialization: A CDMO Perspective

Richard Richieri, chief operations officer, Avid Bioservices Avid has manufactured biologics since the early 1990s. Its early phase and late-phase projects (including commercial biologics) are approved in 90 countries. The company uses 2,000-L single-use bioreactors (three units), two 1,000-L bioreactors, and a few smaller ones, all in single-use configurations. Avid is expanding and will add six 2,000-L single-use bioreactors to its facility. Richieri spoke about the road to biologics commercialization from Avid’s perspective as a contract development and manufacturing organization…

Plasmid Manufacturing Excellence: The Foundation for Multiple New Modalities

Mario Kraft, head of process development, AGC Biologics Kraft leads AGC’s process development team at a site in Heidelberg, Germany. He spoke about his company’s focus on plasmid DNA manufacturing and about how AGC supports its clients’ projects. The company has an established platform production process “toolbox system†for customized manufacturing of high-quality–grade plasmids for both good manufacturing practice (GMP) and non-GMP applications. With the explosion of interest in cell and gene therapies and with their improving clinical success, increased…

The Evolving Role of the Outsourcing Manufacturer: Why CDMO Is the New Normal

Moderator Dan Stanton, with Magnus Schroeder and Daniel P. Slone In the biopharmaceutical industry, manufacturing partners always have served as more than mere suppliers. But they increasingly are expanding their technologies and capabilities with the goal of offering end-to-end services. In this online panel for the 2020 BIO conference, Dan Stanton asked Magnus Schroeder and Daniel P. Slone, both vice presidents at major contract development and manufacturing organizations (CDMOs), “how manufacturers put the D in CDMO†and how biologics development…

Figure Out Any Particle with Automated Counting, Sizing, Morphology, and Identification Using the Hound

This webcast features: Lisa Krapf, Field Automation Scientist, Unchained Labs Thorough particle sizing and analysis are essential steps in formulation development and the monitoring of manufacturing process controls. Traditional particle analysis techniques such as light obscuration do not provide morphological information that can be useful for classification. Transfer to manufacturing and scaling to production will necessitate different equipment and the potential introduction of extrinsic particles that may not have been observed previously. The combination of particle analysis with flexible options…

Accelerate Cell and Gene Therapy Development and Manufacturing with Fully Integrated Closed CAR-T Cell Therapy Platform

For many years, the primary forms of cancer treatment have been chemotherapy, radiation, and surgery. An amazing breakthrough known as chimeric antigen receptor (CAR) T-cell therapy is being studied in the treatment of various types of cancer, including acute and chronic lymphoblastic leukemia, non-Hodgkin lymphoma, myeloma, and solid tumors. Developing innovative advanced therapies is one of our greatest opportunities to dramatically improve patients’ lives. WuXi Advanced Therapies recently announced the expansion of its service capabilities by offering a fully integrated…

Advantages of Custom Chromatography Resin Development: A Viable Solution for Purification of Complex Biotherapeutics

This webcast features: Scott Zobbi, Senior Manager of Business Development, Custom POROS Resins, Thermo Fisher Scientific Advances in biotherapeutic development are generating an increasing range of complex molecules, often presenting unique and complex purification challenges. Addressing these challenges requires novel purification strategies for commercial manufacturing, which may not always exist. When your specific process needs cannot be met with off-the-shelf resins, custom resin production may be a viable solution. Our POROS™ custom resin and CaptureSelect™ custom affinity matrix development platforms…

The evolving demands of the temperature-controlled supply chain for cell and gene therapy

As drugs have become more complex, so too has the supply chain, which must innovate to accommodate the necessary, specialized conditions for the storage and transportation of these drugs, even under extenuating circumstances. As the pharmaceutical industry shifts its attention to biologics and cell and gene therapies, the need for more advanced storage solutions has heightened considerably. In January 2019, former commissioner of the U.S. Food and Drug Administration (FDA) Scott Gottlieb, M.D. issued a statement regarding the impending cell…

Early Stage Analytical Considerations for Late Stage Biologics Success

This BPI Special Report will cover phase appropriate analytical strategies that will balance various drivers to meet overall development goals without sacrificing the requirements of a program. The goal is to provide important recommendations for analytical method development that can help the biopharmaceutical industry identify opportunities to improve lead time and reduce development costs while maintaining required quality standards. Fill out the form below to learn more about analytical method development now.   Arugadoss Devakumar, PhD, is director of analytical…