NANJING, China, Oct. 22, 2024 — HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for “Allogeneic Human iPSC-derived cardiomyocytes (HiCM-188) administered via intramyocardial injection during coronary artery bypass graft surgery.” [Read more…]
AABB Introduces New Cell and Gene Therapy Standards for Pharmacy
Oct 16, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to introduce the proposed first edition of Cell and Gene Therapy Standards for Pharmacy, available for public comment through Dec. 16. These new standards represent an important advancement in ensuring the highest level of quality and safety for cell and gene therapy (CGT) products.
As more and more CGTs gain approval, pharmacies are becoming key players in managing these complex, high-value therapies. A review of existing pharmacy quality programs and available certifications revealed a lack of standards for handling and managing CGTs within pharmacy. [Read more…]
I Peace announces new iPSC lines to reduce immune rejection risk for U.S. population
More than 100 million people in the U.S. have this HLA-A haplotype
October 30, 2024, Palo Alto, CA – Leading G.M.P. cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the company has successfully generated iPS cell lines that are homozygous for HLA A, C, and DPA1. Two clonal lines are available for cell therapy developers and pharmaceutical companies as off-the-shelf products in both G.M.P. and research-grade. [Read more…]
Nucleus Biologics Launches NB-KUL™ DF: A DMSO-Free, Chemically-Defined Cryomedia Revolutionizing Cell and Gene Therapy Cryopreservation
San Diego, CA, October 15, 2024 – Nucleus Biologics, a leading provider of cell culture and bioprocessing solutions for the cell and gene therapy (CGT) industry, has launched NB-KUL DF, a DMSO-free, chemically-defined cryomedia set to redefine cryopreservation standards. Designed for CGT manufacturers, NB-KUL DF matches DMSO-based media performance and outperforms other DMSO-free options in cell viability, recovery, and expansion. While DMSO is an effective cryoprotectant, its toxicity compromises cell viability, can cause patient issues, and requires complex wash steps, adding cost and variability. NB-KUL DF eliminates these issues, offering a DMSO-free solution that preserves cell integrity, eliminates the potential for patient side effects, and simplifies cryopreservation making it ideal for T cells, MSCs, and other sensitive cell types used in CGT. [Read more…]
AABB Releases New Resources and Initiatives For its Certified Advanced Biotherapies Professional (CABP) Program
Oct 11, 2024, Bethesda, MD – The Association for the Advancement of Blood & Biotherapies (AABB) is pleased to announce several new offerings as part of its Certified Advanced Biotherapies Professional (CABP) credentialing program. These updates, released to make the CABP program more accessible to biotherapies professionals and organizations, include:
• CABP Exam Prep Bootcamps Video Series [Read more…]
- « Previous Page
- 1
- …
- 19
- 20
- 21
- 22
- 23
- …
- 116
- Next Page »