BPI Theater

Leveraging Infrastructure Investments and Innovation to Accelerate Biologics Development

Paul Jorjorian, vice president/general manager, biologics, Thermo Fisher Scientific Jorjorian began by noting current trends in drug development, including more compounds being held for longer periods of time than in previous years by small and emerging pharmaceutical and biotechnology companies. He sees an increased complexity of molecules being brought to market, including bispecific antibodies and fusion proteins. Growth continues in both the cell and gene therapy segments and in orphan drug markets. From a business-dynamics perspective, such growth can create…

BioProcess Insider Interviews Timothy Compton

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 Timothy Compton, chief commercial officer at Avid Bioservices. Having settled into its role as a dedicated contract development and manufacturing organization (CDMO), Avid Bioservices is expanding. The company made several changes to its executive and sales teams after refocusing its mission in 2018, recruiting people…

BioProcess Insider Interviews Kevin Sharp

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 Kevin Sharp, director of the Global Business Development Center for Samsung Biologics. The COVID-19 pandemic has compelled substantial changes across the biopharmaceutical industry. But Sharp reported that South Korean CDMO Samsung Biologics is weathering the storm. Samsung quickly joined the South Korean government’s efforts to…

BioProcess Insider Interviews Julien Meissonnier

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 Julien Meissonnier, vice president and chief scientific officer at Catalent Biologics. Contract development and manufacturing organizations (CDMOs) have scrambled lately to gain cell and gene therapy capabilities. That includes Catalent Biologics, which last year acquired Paragon Bioservices and MaSTherCell. Paragon offers expertise in manufacture of…

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…

Will In-House Manufacturing Capabilities Give Cell and Gene Therapy Developers Competitive Advantages?

Moderator Dan Stanton, with Felix Hsu and Joseph Rininger Cell and gene therapy (CGT) developers are seeking out manufacturing capabilities in response to tremendous industry growth. Unprecedented demand is driving facility expansions among major contract development and manufacturing organizations (CDMOs). But CGT companies increasingly are investing in their own production networks. This online panel during the 2020 BIO convention explored whether developing in-house manufacturing capabilities might secure product developers some competitive advantages as the CGT industry matures. Capacity Concerns Stanton…

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…