BPI Theater

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.

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…

Strategies for Implementing New Technologies in an Outsourcing Environment: A Roundtable Discussion

In this Wednesday, 5 June 2019, installment of the BPI Theater at BIO, Tom Ransohoff (managing director, BDO USA) led a roundtable discussion about ways that contract development and manufacturing organizations (CDMOs) can balance client demands while staying current with the rest of the biomanufacturing industry. Featuring Ransohoff, Jésus Zurdo (senior vice president of process science and innovation, Rentschler Biopharma), Andy Topping (chief scientific officer at FUJIFILM Diosynth), and Jesse McCool (Chief Technology Officer at Cytovance Biologics), the panel explored…

Capacity Challenge — How Single-Use Technology Is Meeting the Demand for Commercial Biologics Manufacturing: A Roundtable Discussion

The subject of the final panel in the BPI Theater at BIO was how single-use technologies are enabling companies to meet the demand for commercial biomanufacturing capacity. Over the past decade, the industry has been adopting disposable bioreactors and other bioprocessing equipment for clinical manufacturing of biopharmaceuticals. Moderator Dan Stanton began this discussion by asking panelists where the industry stands currently for single-use technologies in making commercial products. Along with Stanton, the roundtable discussion features John Godshalk (senior consultant, Biologics…

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 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…

Moving Gene Therapies to Market: The Role of Manufacturing Technologies

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…

Your Success to IND and BLA, Faster and Better

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…

Single-Use Stirred-Tank Bioreactors: A Commercially Viable Strategy for Cell Therapy Manufacturing

Representing Hitachi Chemical Advanced Therapeutic Solutions, Alex Klarer spoke to the BPI Theater at BIO on Tuesday, 4 June 2019, about ways to improve patient access to revolutionary T-cell immunotherapies. A feasible solution, Klarer contended, is to develop a form of stirred-batch bioculture that reduces the entire manufacturing process while still maintaining high expansion rates with low media use. To establish this as a possibility, Klarer described his firm’s experiments with small and large batches on a Distek cell culture…