Tracy Kinjerski, vice president of business operations at Avid Bioservices, took to the stage at the BPI Theater at BIO on Wednesday, 5 June 2019, to explain how the firm is faring since it span-out as a pure-play CDMO from Peregrine Pharmaceuticals. In the pursuing 18 months, the firm’s two facilities in Orange County, California, have benefited from large demand from end-users for flexible manufacturing services, and while there are no concrete plans for expansion, Kinjerski said there is an…

The UK’s departure from the European Union and single-market has been delayed, and while a new deadline of October 31 has been set there is no certainty of what will happen. This uncertainty has hit every aspect of UK industry, not least the life sciences space, said Tom Cartwright, a partner at law firm Morgan Lewis. During an interview with Dan Stanton at the BPI Theater at BIO (Wednesday, 5 June 2019), Cartwright remarked that the sector has already seen…

Often biomanufacturing coverage focuses on the extremes: small-scale single-use production or large-scale stainless steel. But with higher titers, potencies and niche indications, the industry is increasingly looking for a middle way, said Stéphane Varray, associate director of commercial development for midscale at Lonza Pharma and Biotech. In this BPI Theater at BIO interview with editor Dan Stanton, Varray observed that multiplexing in single use is an option, but that at some point it makes more sense economically to move to…

On Wednesday, 5 June 2019, Patrick Lucy, chief business officer at Pfenex, told a crowded BPI Theater at BIO about the evolution of his company. While the firm approaches approval of PF708, a therapeutic equivalent to Eli Lilly’s Forteo treatment, Pfenex’s future will focus on novel therapies and strategic partnerships revolving around next-generation antibodies and its gene expression technology.

Maurice Phelan, site head of Cambridge US cell line and testing solutions at Sartorius Stedim Biotech, joined the BPI Theater at BIO on Tuesday, 4 June 2019, to explain how a strong data analytics platform combined with solid product characterization can make all the different in emerging therapy development. An explosion of data has come from the advent of process sensors and process characterization study. With these data, Phelan suggests, sponsors can use platforms such as the Sartorius SICAM system…

Clive Glover, director of strategy for gene and cell therapy at Pall Biotech, presented at the BPI Theater at BIO on Tuesday, 4 June 2019, about how questions of manufacturing scale will dictate new developments and investments in gene therapy technologies. For this reason, Glover added, Pall strives to find ways of reintegrating extant technologies for optimal manufacturing scale. Once a drug sponsor and Pall reach consensus about process parameters, Pall initiates an integrated solutions design that helps it and…

In this BPI Theater at BIO presentation, delivered on Wednesday, 5 June 2019, Eun Young Yang, executive director and head of the CSO business team at Samsung Biologics, explained how the firm’s end-to-end service increases the chance of commercial success for investigational new drugs (INDs). In addition to fully integrated development and manufacturing services for IND filing, Samsung offers regulatory expertise that can usher sponsoring organizations through clinical trials for monoclonal antibodies (MAbs), fusion proteins, bispecific antibodies, and multispecific antibodies…