“Merck & Co Inc said on Tuesday it had got a nod from the U.S. Food and Drug Administration for its already-approved immunotherapy drug Keytruda as a treatment for a type of blood cancer. The nod from the FDA marks the first approval of the treatment for blood cancer. Keytruda is already approved for treating lung, head and neck cancers, among others.”
“The pharmaceutical companies GlaxoSmithKline and Sanofi sell many doses of vaccines at high prices and do a lot of research with the profits, while the Serum Institute of India makes more doses than any other manufacturer and sells them at low prices, according to the first Access to Vaccines Index, which was released last week.”
“BIO, Pew Weigh FDA’s Revised Draft Guidance on Mixing, Diluting or Repackaging Biologics,” Regulatory Focus
“The Biotechnology Innovation Organization (BIO) and the Pew Charitable Trusts are offering their input on the US Food and Drug Administration’s (FDA) recently revised draft guidance on mixing, diluting or repackaging biologics. While both organizations say the revised draft guidance is a step in the right direction, BIO says several aspects of the guidance still raise concerns.”
“Vedantra Pharmaceuticals said today it will partner with Neon Therapeutics to develop cancer vaccines, through a nonexclusive research collaboration whose value was not disclosed. The companies will explore combining Vedantra’s albumin-binding, lymph node-targeting amphiphile technology with Neon’s capabilities in neoantigen vaccine research. The objective of the joint research collaboration, Vedantra said, is to continue development of therapeutic vaccines that raise immune responses against neoantigens that allow the body to naturally expand immune cells capable of destroying infected or cancerous cells, without harming normal tissues.”
“President Trump said Friday that he intended to nominate Scott Gottlieb, a partner at a venture capital fund with longstanding ties to the pharmaceutical and biotech industries, to lead the Food and Drug Administration.”
“Allergan plc said on Tuesday it would get exclusive access and the option to license up to five of Editas Medicine Inc’s experimental gene-editing-based eye treatments under a research and development deal between the two companies.”
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.
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