Thursday, August 6, 2020 Daily Archives

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…

Moderna on $1.3bn manufacturing scale-up of mRNA COVID vaccine

Moderna is confident of attaining 500 million doses of its COVID-19 vaccine candidate after using proceeds from a stock offering to scale-up manufacturing at its site in Massachusetts and at CDMO Lonza. In May, Moderna Therapeutics raised $1.3 billion through the sale of shares. According to the prospectus, the funds were to be used for “raw materials, labor and capital equipment purchases related to the manufacturing of mRNA-1273,†Moderna’s messenger RNA vaccine candidate in late-stage trials for COVID-19. This money…