Introducing IRO®, the new standard in CGT #manufacturing technology.
Manufacturing remains a critical barrier to scaling CGTs, limiting the clinical and commercial impact of this lifesaving new class of therapies.
That’s why we developed IRO®.
➡️ oribiotech.com/press-release…
Today we introduce the CellSeal® CryoCase™ closed-system rigid container at the @ISCTglobal Conference in Vancouver.
Read the press release for more details.
go.biolifesolutions.com/l/10…
Did you catch this @BioProcessIntl piece by Brent Morse and Alicja Fiedorowicz? "Analytical Considerations for Gene-Modified Hematopoietic Stem and Progenitor Cell Therapies: Part 1 — In-Process and Drug Product Control."
Read now, here! bioprocessintl.com/cell-ther…
NY Governor Releases Request for Proposals for State-of-the-Art Cell and Gene Therapy Hub on Long Island.
More Than $150M Available Builds on Governor’s Commitment to Boosting Fast Growing Sectors Like Life Sciences — Including State Commitment to Establishing Two Cell and Gene Therapy Hubs
New Hub Will Help to Position New York State as National Leader in Cell and Gene Therapies
governor.ny.gov/news/governo…
BREAKING!💥Bahrain🇧🇭 has become the second country in the world and the first in the Middle East to approve the use of CASGEVY (Exa-Cel from CRISPR Tx) for the treatment of patients with sickle cell disease and transfusion-dependent beta-thalassemia. $CRSP$VRTX#CRISPR
If you have not participated in the @US_FDA's crowdsourcing initiative: Envisioning the Future for Biological Products, then get to it! You have 2 days left.
Bring your insights and expertise to CBER’s crowdsourcing community designed to share ideas, solutions, and visions for the future of biologics. The goal of this crowdsourcing initiative is to gather external ideas on major advances in product development for CBER-regulated products, including novel products and product manufacturing methods that are likely to emerge in the next 3-10 years. fda-cber.ideascalegov.com/c/…
On the 27th, the @FDACBER CTG Therapies Adv Comm will meet in open session to discuss and make recommendations on @BrainstormCell's biologics license application for debamestrocel (autologous bone marrow-derived MSC #celltherapy) for the treatment of amyotrophic lateral sclerosis (ALS).
fda.gov/advisory-committees/…
What is this the 3rd time around? Maybe they should have listened to the FDA the first time or second time.
_____
Mesoblast's CEO takes 30% pay cut to fund 3rd shot at cell therapy approval fiercebiotech.com/biotech/me…
Despite the obfuscating press release, the short of it for @biocardia$BCDA, is the DSMB did a futility analysis and concluded the ph 3 trial was unlikely to meet the PE but mgmt convinced them to pause the trial pending the 12-month outcomes analysis.
markets.businessinsider.com/…
If you've ever thought analytical technologies for #celltherapies are a black hole, then we aim to crowdsource you some answers. We've launched a project trying to shed some light on existing and up-and-coming analytical technologies.
Help us help you.
docs.google.com/forms/d/e/1F…