weekly biotechnology news wrap up

June 2, 2017

June 2, 2017

This week’s headlines include: A Look at Major Drug-Pricing Proposals, Kite gets FDA priority review for KTE-C19, putting it 2 months behind Novartis in race for CAR-T market, JSR Corp arm KBI Biopharma to invest $ 30 mn to expand two facilities in US, ImmunoGen Licenses Cancer Compounds to Sanofi, Philips in deals with U.S. hospitals on use of its gene data platform for cancer research, and Death rate from Alzheimer’s disease in the US has risen by 55%, says CDC,” CNN.com


Headlines:

“A Look at Major Drug-Pricing Proposals,” The New York Times

“Several bills that seek to tackle the high cost of prescription drugs are moving through Congress, and the Trump administration has also signaled that it may take action. Here’s a list of the major drug-pricing proposals under consideration…”

“Kite gets FDA priority review for KTE-C19, putting it 2 months behind Novartis in race for CAR-T market,” Fierce Biotech

“Kite Pharma has secured a priority review at the FDA for its CAR-T candidate. The shaving of four months off the review time tees Kite up to secure approval by the end of November, two months after Novartis is expected to get the all-clear to start selling its rival CAR-T therapy…”

“JSR Corp arm KBI Biopharma to invest $ 30 mn to expand two facilities in US,” Business Standard

“KBI Biopharma (KBI), a subsidiary of JSR Corporation (JSR), is expanding its biopharmaceutical manufacturing capacity and capabilities at both its Durham, North Carolina and Boulder, Colorado facilities. KBI will invest approximately $ 30 million in the two site expansion projects, which will greatly enhance the offerings at each site and are scheduled for completion later this year…”

“ImmunoGen Licenses Cancer Compounds to Sanofi,” Genetic Engineering News

“ImmunoGen said today it has granted exclusive licenses to four compounds using its technology that are being developed by Sanofi, under amendments to the companies’ 14-year-old collaboration. ImmunoGen, which focuses on antibody–drug conjugates (ADCs), agreed to amend a 2003 agreement between the companies by granting Sanofi a fully paid exclusive license to develop, manufacture, and commercialize four cancer candidates…”

“Philips in deals with U.S. hospitals on use of its gene data platform for cancer research,” Reuters

“Dutch healthcare technology company Philips said Thursday it had reached deals with New York’s Memorial Sloan Kettering Cancer Center (MSK) and Utah-based Intermountain Healthcare for them to use its genomics platform for cancer research and treatment…”

“Death rate from Alzheimer’s disease in the US has risen by 55%, says CDC,” CNN.com

“The rate of people dying from Alzheimer’s disease in the United States rose by 55% over a 15-year period, new data from the Centers for Disease Control and Prevention shows…”

Recent Articles on Cell Culture Dish and Downstream Column:

Cell Culture Dish


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Webinars:

A Versatile Solution for Host Cell Proteins (HCPs) and Aggregates Removal for mAbs Purification

Presented by: Catherine Allioux & Caine Leong, Ph.D.
Date: Thursday, June 08, 2017 – 1:00 PM EDT
Duration: 1 hour

Downstream process developers are continually seeking contemporary ways to enhance the removal of HCPs and aggregates during mAbs production.

You are invited to register for a webinar on June 8th, to discover how you can eliminate these challenges with versatile solutions that deliver successful removal of HCPs and aggregates over a broad range of conductivity and pH to fit with any mAb, while using a platform process adaptable to both batch and continuous processing.

Attendees will gain firsthand methodology and insights on optimizing process development requirements with CMM HyperCel™ high capacity cation exchange mixed-mode sorbent from a team of Pall Life Sciences experts. The webinar will close with a Q&A session.

Continuous Bioprocessing Technology and Regulatory Considerations

Wednesday, June 14, 2017, 01:00 PM EDT

SUMMARY

Many industries have adopted a one-piece flow approach (continuous manufacturing) to leverage the core reductions in inventory, increased operational flexibility, and greater product consistency and quality that it delivers. However, biopharmaceutical manufacturers have been slow to put continuous processing theory into practice due to the highly-regulated nature of the industry.

On June 14th at 1pm EDT, Peter Levison, PhD will moderate as Mani Krishnan, PhD and Marc Bisschops, PhD examine the evolution of interest in continuous bioprocessing, the advances being made in today’s market, and how the regulatory authorities are responding. Mani will also offer insight into the technological challenges of implementing continuous bioprocesses, and potential regulatory questions surrounding batch definition, bioburden control, virus clearance, scale-up/down, defect perturbation, design space, etc.; he will also propose effective mitigation strategies for a successful transition to continuous bioprocessing.

Registration for the Americas

Registration for Europe/Asia

SUMMARY

Continuous multi-column chromatography (MCC) has been gaining increasing interest as an enabling bioprocessing technique that allows for increases in specific productivity (g/L/hr) and operating binding capacity (g mAb/L sorbent) over traditional batch solutions. With recent advances, users have reported an increase in cost savings stemming from reduced resin volumes, lower buffer consumption, and increased resin usage.

Mark Pagkaliwangan presents on July 18th at 1PM EDT, with David Johnson moderating, as they discuss MCC solution advances with processes utilizing two columns or more. They will explore how the total number of columns used in a process can affect performance, and how titer and flowrate can be optimized with more columns for greater efficiency and productivity.

Registration for the Americas

Registration for Europe/Asia

Cell Culture Events:

Cell Culture & Cell Therapy: Bioprocessing Conference – June 26-27, 2017, Philadelphia

MarketsandMarkets put together a unique platform to establish the reproducible and robust manufacturing processes for the production of stable cell culture and therapeutic cells. At the Cell Culture & Cell Therapy: Bioprocessing Conference scheduled to be held in Philadelphia, USA on 26 – 27 June 2017, leading experts in the industry will be gathered to discuss strategies, technologies and innovations in the area of bioprocessing of cell culture and cell-gene therapies.