weekly biotechnology news wrap up

March 24, 2017

March 24, 2017

This week’s headlines include: Bad luck mutations increase cancer risk more than behavior, Drug ‘reverses’ ageing in animal tests, New Vaccine Could Slow Disease That Kills 600 Children a Day, FDA fees for product review would more than double under Trump budget, Cell Medica Raises £60M for Phase II T-Cell Product and Cell Immunotherapy Pipeline, and New blood biomarker could enhance early detection of heart attack risk.


Headlines:

“‘Bad luck’ mutations increase cancer risk more than behavior, study says,” CNN

“For the first time, researchers have estimated what percentage of cancer mutations are due to environmental and lifestyle factors, hereditary factors and random chance. Overall, 66% of the genetic mutations that develop into cancer are caused by simple random errors occurring when cells replace themselves, according to a new study published in the journal Science. Environmental factors contribute 29% of mutations, while the remaining 5% are inherited, say Cristian Tomasetti and Dr. Bert Vogelstein, both of Johns Hopkins University…”

“Drug ‘reverses’ ageing in animal tests,” BBC News

“A drug that can reverse aspects of ageing has been successfully trialled in animals, say scientists. They have rejuvenated old mice to restore their stamina, coat of fur and even some organ function. The team at Erasmus University Medical Center, in the Netherlands, are planning human trials for what they hope is a treatment for old age…”

“New Vaccine Could Slow Disease That Kills 600 Children a Day,” The New York Times

“A new vaccine against a diarrheal disease that kills about 600 children a day worked well in a large trial in Africa and appears to be a practical way to protect millions of children, scientists said on Wednesday. The new vaccine against rotavirus, the most common cause of death from diarrhea in children under age 5, is made by an Indian company and was tested in Niger by Doctors Without Borders…”

“FDA fees for product review would more than double under Trump budget,” Reuters

“The cost to healthcare companies for U.S. regulatory review of their products, including drugs and medical devices, would more than double under the Trump administration’s proposed 2018 budget. For 2018, the Trump administration has budgeted over $2 billion in fees to be collected by the U.S. Food and Drug Administration from industry, twice as much as in 2017, according to budget documents released on Thursday…”

“Cell Medica Raises £60M for Phase II T-Cell Product and Cell Immunotherapy Pipeline,” Genetic Engineering News

“Cell Medica raised £60 million ($74 million) in a Series C round of financing to support development of its cell-based immunotherapy platforms and pipeline, including lead mid-stage oncology candidate  baltaleucel-T (CMD-003). The autologous T-cell therapy is being evaluated in the Phase II CITADEL study and the CIVIC trial as a treatment for advanced lymphomas associated with Epstein Barr virus (EBV)…”

“New blood biomarker could enhance early detection of heart attack risk,” Fierce Biotech

“When it comes to predicting who’s at risk of suffering a heart attack or other major cardiac event, physicians have long relied on detecting high levels of C-reactive protein (CRP), an inflammatory biomarker. But new research suggests CRP may not be the only game in town…”

Webinars:

Accelerating the development of regenerative therapies: Large scale expansion of human mesenchymal stem cells – March 28, 2017

Pall has partnered with RoosterBio to commercialize Allegro™ Unison human mesenchymal stem cells (hMSCs) and bioprocess media to accelerate cell therapy and regenerative medicine development. Use of Allegro Unison products along with SoloHill microcarriers, Allegro biocontainers, and the PadReactor® bioreactor system moves the industry towards execution of the technology roadmap to achieve lot sizes of 100s of billions to >1 trillion hMSCs, without the need for extensive and costly process development. Large scale hMSC expansion is now rapidly achievable in a robust, scalable, reproducible, and economic manner.

This webinar details the total solution for large scale expansion of human mesenchymal stem cells. We will present a case study highlighting large scale cell culture and expansion of hMSCs to billions of cells, within ten days of culture, in a fed-batch 50L bioreactor system.

Register to Learn:

  • How Allegro Unison hMSCs and bioprocess media, SoloHill microcarriers and Pall PadReactor systems enable large-scale hMSC expansion.
  • Culture protocol for 200-fold hMSC expansion, within 10 days, in a single-use, fed-batch scalable manufacturing platform.
  • How regenerative medicine and cell therapy developers can rapidly and economically move towards producing tens of billions to >1 trillion high quality hMSCs for product development programs in single-use bioreactors.

Cell Therapy – Achieving Success on the Road to Commercialization – April 5, 2017

The success of developing a cellular therapy rests on the ability to deliver a viable, potent product. This positive end-result is directly attributable to the strategy in place and the supporting processes. A reliable cell therapy development strategy is imperative to ensuring your therapeutic materials remain viable from the point of collection, through manufacture, to the final clinical site delivery.

This webinar will review some of the key components to consider when developing your strategy to minimize risk, manage cost, and ultimately deliver a product to market.

Key Learning Objectives:

    • Minimizing variability through the use of collection and administration kits and SOPs
    • Understanding the importance of validating process and qualifying equipment as well as data collection early and throughout Study/Phase 1 to commercial
    • Leveraging data to maintain cell integrity, improve process, reduce risk, analyze and strengthen weak points
    • Maintaining chain of custody and real time communications
    • Understanding the importance of tracking and monitoring to ensure the right patient receives the right material at the right time
    • Considering scalability from Day 1

Recent Articles on Cell Culture Dish and Downstream Column:

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Cell Culture Events:

World Vaccine Congress – April 10-12, 2017, Washington D.C.

The 17th Annual World Vaccine Congress is the place where the global vaccine industry meets to discuss commercial and scientific issues around regulation, strategy, manufacturing, trials, partnering, influenza, cancer, emerging diseases and veterinary vaccines.

Across 150 sessions, you will learn from leading experts across the issues most impacting on the wider vaccine sector, as well as delve into your specialist area of research and job focus in co-located conferences.

Meet over 700 of your peers in one room and take advantage of the multiple extended networking breaks, co-located World Vaccine Congress (including 7 streams on Immune Profiling, Cancer & Immunotherapy, Influenza & Respiratory, Clinical Trials, Emerging Diseases, Partnerships, Veterinary Vaccines and Bioprocessing & Manufacturing) as well as the evening drinks reception.

For more information, please visit the website https://goo.gl/nJ2bZ1

Cell Culture World Congress USA 2017 – May 24, 2017, Hilton San Diego Resort and Spa, San Diego, CA

The vision of Cell Culture World USA is to provide new, relevant content on process development for cell culture specific scientists working in bio manufacturing companies developing antibodies and immunotherapies. Over 4 years, the Congress has become a technical and networking forum for bioprocessing professionals to provide cutting-edge commentary, present novel and never-before-seen case studies, and highlight technological advancements to the industry.

Our 2017 event will feature a more focused structure, zeroing in on the topics that interest cell-culture specific scientists the most. Immunotherapies are the talk of the industry, and they’ll be a huge topic for this year’s event as well.

Download Brochure: https://goo.gl/t5ZRvx

Register now: https://goo.gl/KTOdxq

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.