March 7, 2023, SAN DIEGO, CA — In a joint effort to accelerate high-quality therapies to market, Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media solutions for the cell and gene therapy industry, and Stoic Bio, a provider of sustainable technology for cell media manufacturing, have announced plans for a supply agreement with the Center for Breakthrough Medicines (CBM), a leading contract development and manufacturing organization (CDMO), whose mission is to save lives by accelerating the development and manufacture of advanced therapies. This agreement makes Nucleus Biologics the preferred supplier of cell culture media and other critical biological solutions for CBM; thus, ensuring a steady, consistent supply of this critical material with tighter quality control measures. [Read more…]
Caribou Biosciences Granted FDA RMAT and Fast Track Designations for CB-010, an Allogeneic Anti-CD19 CAR-T Cell Therapy
RMAT and Fast Track designations follow CB-010’s durable complete responses at dose level 1 in the ANTLER Phase 1 trial
CB-010 is the 1st allogeneic CAR-T cell therapy in the clinic with a PD-1 knockout
CAR-T Market: Current State, Future Directions, and Trends
The global CAR-T market has grown exponentially since the first CAR-T approval reached the market in 2017. Over the past four years, a growing pipeline of CAR-T clinical trials have been accumulating, leading to six global approvals and an explosion of CAR-T market competitors worldwide. [Read more…]
Market for cord blood and perinatal tissue in 2022
Over the past 30 years, cord blood and cord tissue have gained popularity and commercial traction due to the valuable stem cells they contain. According to ClinicalTrials.gov, there are over 1,360 clinical trials evaluating the use of cord blood and tissue-derived cells. These studies typically leverage unmanipulated whole cord blood (total nucleated cells/TNC), mononuclear cells (MNC), or cord blood-derived mesenchymal stem cells (MSCs). [Read more…]
8th Perinatal Stem Cell Society Congress/Workshop Coming Soon
The 8th Perinatal Stem Cell Society Congress/Workshop is taking place November 3, 2022, at the Westin Beach Resort in Fort Lauderdale, FL.
$599 Early Bird Ticket Sales Close Oct. 15th
After Oct. 15th the price is $899
Please register here
As a patient advocate, my aim is to create affordable access to safe stem cell and biologic therapies in the United States. There is an opportunity to work with FDA at this time to make substantial and long-lasting changes to the IND pathways. I have called this one-day workshop so that the industry can come together, not to challenge the FDA, but to work with FDA to find solutions that will enable access to life changing therapies for patients in the U.S. [Read more…]
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