“Roche’s multiple sclerosis (MS) drug Ocrevus won U.S. approval, putting the potential blockbuster back on track after a brief delay and giving a lift to patients with a form of the disease that until now had no approved treatment. The drug, also known as ocrelizumab and administered via infusion, becomes the first U.S. Food and Drug Administration-approved medicine for the primary progressive form of the neurological disease (PPMS)…”
“Thermo Fisher Scientific and the Cell and Gene Therapy Catapult Collaborate to Optimise Advanced Therapy Supply Chain,” Business Wire
“To help address the challenges surrounding supply chain management for cell and gene therapy around the globe, Thermo Fisher Scientific, the world leader in serving science, today announced a collaboration with the Cell and Gene Therapy Catapult (CGT Catapult) to provide developers with both the manufacturing capability and distribution, logistics, and storage capacity needed to create a seamless supply chain to accelerate cell and gene therapy development and commercialsation…”
“Where’s Jordan?” asked Vice President Pence as he walked into the White House meeting of terminally ill patients and their families. All eyes shifted, and Pence made a beeline for a 7-year-old boy from Indianapolis with a broad grin. Back home, when Pence was Indiana’s governor, Jordan McLinn and his battle with Duchenne muscular dystrophy had helped inspire passage of a state “right-to-try” law intended to give the desperately ill access to medications not yet approved by the Food and Drug Administration. Fast-forward to Washington, where Pence is now in a position to encourage national right-to-try legislation…”
“The Parker Institute for Cancer Immunotherapy, Bristol-Myers Squibb (BMS), and the Cancer Research Institute (CRI) said today they will partner to speed up discovery and development of new immuno-oncology treatments. The value of the multiyear clinical research collaboration was not disclosed. BMS becomes the first biopharma to partner with the Parker Institute and CRI. The company said it will solicit clinical research proposals from the Parker Institute and CRI researcher networks, as well as coordinate multisite clinical studies aimed at what the company calls the most difficult questions in cancer research…”
“Takeda’s Dengue Vaccine Candidate Elicited Broad Immune Responses in Children and Adolescents Living in Dengue-Endemic Areas; Interim Phase 2 Analysis Published in The Lancet Infectious Diseases,” Yahoo Finance
Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) today announced that data from a 6-month interim analysis* of the ongoing DEN-204 trial of its live-attenuated tetravalent dengue vaccine candidate, TAK-003 (also referred to as TDV), have been published in The Lancet Infectious Diseases…1
“A glimmer of hope against pancreatic cancer has come courtesy of Erytech (OTC:EYRYY), a little-known French biotech, which appears to have extended the asparagine synthetase hypothesis to this extremely failure-prone cancer type. The success was doubly unexpected: after hedging its bets with patient selection, Erytech suggests that Graspa, the project in question, in fact, worked in all comers. A major caveat, however, is that Graspa’s precise significance on the primary endpoint is unclear, which could call into doubt broader data analyses…”
“AstraZeneca has won approval for its lung cancer pill Tagrisso in China, a key market for the potential blockbuster medicine. Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British drugmaker’s prospects in a key therapy area…”
“Myeloma UK has launched a ground-breaking immunotherapy trial which aims to modulate the immune system to target myeloma. In what the charity describes as a “world first”, the Phase Ib study, called MUK eleven, will investigate Oncolytics Biotech’ oncolytic virus Reolysin (pelareorep) in combination with immunomodulatory drugs as a rescue treatment in relapsing myeloma patients…”
Accelerating the development of regenerative therapies: Large scale expansion of human mesenchymal stem cells – April 4, 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