Friday, July 19, 2019 Daily Archives

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

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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…

July 19, 2019

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

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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…

July 19, 2019

Emerging Therapy Development: Raising the Probability of Success

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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…

July 19, 2019

Moving Gene Therapies to Market: The Role of Manufacturing Technologies

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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…

July 19, 2019

Your Success to IND and BLA, Faster and Better

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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…

July 19, 2019

Pall to provide ‘A-Z of single-use tech’ in Servier deal

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Servier has selected Pall Corporation as its exclusive technology and services provider at its biomanufacturing facility in Gidy, France. The facility, located about 50 km south of Paris, forms part of Servier’s oncology drug development and production network, Bio-S. This unit will be used for the manufacture of recombinant proteins and monoclonal antibodies, using equipment and processes supplied and supported by Pall Biotech. “Pall will assist Servier with technical support for the scale up of the process to enable Servier…

July 19, 2019