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AbbVie on Balancing the CMO Space with Its Own Pipeline

How does a firm that owns and produces the world’s top-selling drug, among others, leverage its global manufacturing network to offer contract manufacturing organization (CMO) services? Jennifer Cannon, vice president of operations for commercial development at AbbVie Contract Manufacturing, joined the BPI Theater at BIO on Tuesday, 4 June 2019, to describe how intricate this operation is, particularly as the firm balances forecasts for its Humira (adalimumab) product line and its in-house biologic pipeline with growing manufacturing demands from its…

Sartorius’s Bioanalytics Seeing High Return from Cambridge Biotech

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…

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. Fill out the form below to watch his talk now.

Embedded Particles in Single-Use Bags: Risk to Bag Integrity and Drug Product Purity, or Only a Cosmetic Defect?

When using single-use systems (SUS) to process biopharmaceuticals, preventing drug product contamination from extractables and leachables (E&Ls) and embedded particulate matter (gel particles) in the polymer films used to make bioprocess bags is critical. Using a pressure burst test to assess film integrity, Sartorius Stedim Biotech’s Klaus Wormuth and colleagues compared Flexboy and Flexsafe samples with gel-particle-free materials to assess their potential for contamination. The results showed that only large (2–4 mm2) gel particles affected the burst test results, concluding…

Emerging Therapy Development: Raising the Probability of Success

Maurice Phelan, site head of Cambridge US cell line and testing solutions at Sartorius Stedim Biotech, joined the BPI Theater @ 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…