BPI Theater

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…

The Role of New Technology in Enabling Cell and Gene Therapies

Moderator Doug Miller, with Tim Kelly, Daniella Kranjac, Andy Ramelmeier, and Ran Zheng This part of the BPI Theater program focused on emerging bioprocess technologies and their implications for cell and gene therapy (CGT) products. Doug Miller assembled a panel showcasing a wide range of technical expertise and representing several CGT industry stakeholders. That pluralism yielded far-reaching discussions about what CGT capabilities exist, what advances could facilitate therapy manufacture, and how companies might pursue technological development. Viral-Vector Therapies Miller kicked…

Breaking Through the Noise – An Approach to Differentiating Your Business

In this presentation to the BPI Theater at BIO on Wednesday, 5 June 2019, Kiran Chin introduced MKA Insights, a new firm focused on helping bioprocess, life science, clinical diagnostics, and gene therapy companies accelerate their growth. Although there’s no shortage of information on data processes, Chin has found that many companies neglect fundamentals that drive commercialization strategies. Many executives dive in without asking basic questions — ones that Chin brings to the fore: Why do we exist? What are…

DNA Encoded Library Platform at WuXi AppTec

On Wednesday, 5 June 2019, Letian Kuai delivered a presentation to the BPI Theater at BIO about the role of machine learning in drug design. In many cases, Kuai said, drugs are developed by accident. Researchers are beginning to leverage artificial intelligence to make those accidents occur more quickly and predictably. To that end, WuXi has developed a DNA encoded library (DEL) platform based on combinatorial chemistry principles and bolstered by artificial intelligence. This technology, Kuai suggests, could enable unprecedented…

China Biopharmaceuticals: Increasing In-Bound and Out-Bound Investments

Eric Langer, President of BioPlan Associates, joined the BPI Theater at BIO on Wednesday, 5 July 2019, to report recent movements in China’s biopharmaceutical markets. In collaboration with the Society for Industrial Microbiology (SIM) and 102 different authors from around the world, BioPlan conducted a peer-reviewed analysis of the factors driving product development in China. Results showed that market data are not the biggest factor; it is the high incidence of cancer diagnosis and death. Considering this great need and…