BPI Theater

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…

Process Development of a Closed CAR-T Manufacturing Process

Representing GE Healthcare, Rohin Iyer joined BPI Theater at BIO on Tuesday, 4 June 2019, to explore how academic and clinical drug sponsors could partner with service providers to develop bioprocesses more akin to those in the industry at large. Iyer chronicled GE’s collaboration with the non-profit Center for Commercialization of Regenerative Medicine (CCRM), a public–private partnership in which a team of 105 people (both GE Healthcare and CCRM employees) work together at one location. Elaborating this example, Iyer pointed…

Blockbuster 2.0: Who’s Ready?

During a BPI Theater at BIO presentation on Wednesday, 5 June 2019, Charles Christy, director of commercial development at Ibex Solutions (Lonza Pharma and Biotech), considered the increasing speed of molecule discovery, process development, and clinical approval in the biopharmaceuticals industry. Weighing the promises and pitfalls of such a volatile, uncertain market, Christy offered drug developers advice about when to build biomanufacturing facilities in-house and when to outsource services. One solution, Christy suggests, is to partner with agile contract development…

Quality Considerations for Introducing New Products into Your Facility

Ray Marzouk, vice president of quality at Avid Bioservices, joined the BPI Theater at BIO on Wednesday, 5 June 2019, to call out factors that drug developers often neglect when they are deciding whether to enlist a contract development manufacturing organization (CDMO) for scaling up and introducing new therapies in a competitive market. Citing examples related to ICH Q5d cell banking rules, Marzouk explained how Avid conducts smooth and rapid transfers of key process elements and quality diagnostics. Streamlining that…