On Tuesday, 4 June 2019, Andy Topping, chief scientific officer of FUJIFILM Diosynth Technologies, spoke to the BPI Theater at BIO about analytical methods for viruses and gene therapy products. Effective analysis, he argued, requires methods from both classic and contemporary virology, as well as means that have long been used for more traditional biologic products. Even basic questions about a gene therapy product —  about how much product you have made, how many vials have been filled, and what…

In this Tuesday, 4 June 2019, presentation at the BPI Theater at BIO, James Brown, vice president of corporate development at Aldevron, chronicled the development of his firm’s off-the-shelf plasmid products. Offering examples of the key partnerships that Aldevron has forged in the industry, including its collaboration with Asklepios BioPharmaceutical in producing the PLDX80 proprietary helper plasmid, Brown explained how Aldevron’s standardized plasmids can help companies to produce the viral vectors needed for novel gene therapies.

To conclude day one of the BPI Theater at BIO (Tuesday, 4 June 2019), Maurice Phelan, head of cell line and testing solutions at Sartorius Stedim Biotech’s Cambridge (US) site, spoke with Bioprocess Insider’s Dan Stanton to discuss the necessity of third-party analytics, quality control (QC), and characterization. He explained how Sartorius grew into the space through the acquisitions of European service firms Cellca and BioOutsource, and the firm’s decision to consolidate the services in Cambridge, Massachusetts, to be on…

Catarina Flyborg, general manager of cell and gene therapy business at GE Healthcare, told the BPI Theater at BIO (Tuesday, 4 June 2019) how confidence in advanced therapies sparked by a string of approvals is driving interest in the space. Now the challenge lies in tuning the manufacture of the hundreds of products moving through the clinic. By leveraging its experience in the bioprocess space and through mergers and acquisitions (M&A) and partnerships, GE Healthcare is actively addressing issues including…

Celonic CEO Konstantin Matentzoglu spoke to Dan Stanton at the BPI Theater at BIO (Tuesday, 4 June 2019) about the state of the biologics contract development manufacturing organization (CDMO) industry and his company’s ambition in the space. He divulged details of the firm’s recent €50 million ($56 million) expansion at its Heidelberg, Germany site, adding 4,500 square meters of cleanroom space to feed the increased demand for biologics manufacturing services, and spoke of a similar investment at a site in…

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…