April 21, 2017

April 21, 2017

This week’s headlines include: In a Dragon’s Blood, Scientists Discover a Potential Antibiotic, Novartis advances with push on cancer and liver disease, Lion Biotechnologies, MD Anderson Plan Clinical Trials of TIL Cancer Therapy, Novartis drug development chief outlines CAR-T research commitment, BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products, and Enzyvant receives FDA breakthrough therapy designation for investigational therapy rvt-802.


Headlines:

“In a Dragon’s Blood, Scientists Discover a Potential Antibiotic,” The New York Times

“Biochemists may have discovered a type of antibiotic that sounds like something out of a fairy tale: It is based on dragon blood. Scientists from George Mason University recently isolated a substance in the blood of a Komodo dragon that appeared to have powerful germ-killing abilities. Inspired by the discovery, they created a similar chemical in the lab and dubbed it DRGN-1.”

“Novartis advances with push on cancer and liver disease,” Reuters

“Novartis’s push into oncology and liver disease, two of its treatment priorities, advanced on Monday as the Swiss drugmaker won a second U.S. breakthrough tag for its cancer gene therapy while striking a separate pact with Allergan.”

“Lion Biotechnologies, MD Anderson Plan Clinical Trials of TIL Cancer Therapy,” Genetic Engineering News

“Lion Biotechnologies will partner with The University of Texas MD Anderson Cancer Center to carry out multiarm clinical trials assessing the company’s tumor-infiltrating lymphocyte (TIL) therapy in ovarian cancer, various sarcomas, and pancreatic cancer, through a collaboration whose value was not disclosed.”

“Novartis drug development chief outlines CAR-T research commitment,” Fierce Biotech

“Despite reports that linked Novartis to cutting back on its cell therapy work, the Swiss major said it is going full steam ahead for its CAR-T research as a potential approval for its candidate appears on the horizon.”

“BIO, AdvaMed Seek to Tweak FDA’s New Pre-Request Draft Guidance for Combo Products,” Regulatory Focus

“Industry groups BIO and AdvaMed are seeking some changes to the US Food and Drug Administration’s (FDA) guidance on requesting informal input on combination product designations.”

“Enzyvant receives FDA breakthrough therapy designation for investigational therapy rvt-802,” Reuters

“Enzyvant receives FDA breakthrough therapy designation and regenerative medicine advanced therapy designation for investigational therapy rvt-802.”

Recent Articles on Cell Culture Dish and Downstream Column:

Cell Culture Dish


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Webinars:

Design, Characterization, and Scale-Up Strategy for a New Single-Use Production-Scale Bioreactor – April 27th 11:00 EST

The design of the initial range of single-use stirred bioreactors was cylindrical, essentially copying that of traditional stainless steel bioreactors. The cylindrical shape with dished ends was intended to minimize the expensive steel stainless wall thickness and still be strong enough to withstand the internal pressure developed during steam sterilization. However, since single-use biocontainers can be supplied presterilized, novel shapes can now be considered. Indeed a square cross-section design demonstrates some significant advantages over a cylindrical one.

This GEN webinar will first introduce and discuss the engineering concepts of the Allegro™ STR bioreactors, a square bioreactor design with volumes of 200 L, 1000 L, and 2000 L, and then utilize these concepts to demonstrate scale-up from the bench with a live culture.

Who Should Attend

  • Upstream bioprocessing engineers
  • Upstream process development scientists
  • Clinical and commercial manufacturing supervisors and technicians
  • QA/QC scientists

You Will Learn

  • Why a square cross-section brings significant advantages to the upstream process, for handling, process assurance, while maintaining optimal cell culture performance
  • About the performance of a square-shaped bioreactor, in terms of mixing efficiency, mass transfer of oxygen (kLa), and CO2 stripping
  • Applying system engineering principles toward bioreactor characterization, and how tech transfer methods are leveraged across designs, from the bench to production vessels

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.