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…
Monday, July 22, 2019 Daily Archives
GE Healthcare Working to Overcome Advanced Therapy Manufacturing Difficulties
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 Takes the Plunge into Cell and Gene Therapies
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…
Flexible Manufacturing a Boon for Avid in the CDMO Sector
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…
Brexit Uncertainty Is Damaging the UK Life Science Space
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…
Midscale a Major Opportunity for Lonza
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…
Pfenex Set to Ride High on Pipeline and Partnerships
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.
Roundtable Discussion: Cell and Gene Therapies — Keep the Work In-House, or Use a Third Party?
Today’s cell and gene therapies are proving themselves to be viable entities. However, as more products leave the clinic for commercialization, new questions emerge: Is enough manufacturing capacity available? How do companies reduce cost of goods (CoG) and increase manufacturing efficiency? Should a developer build its own capabilities or use a third party? What benefits can a contract development and manufacturing organization (CDMO) bring to this space? BioProcess Insider editor Dan Stanton posed these questions to a range of industry…