GC Therapeutics Emerges with $75M and Star-Studded Leadership to Launch Off-the-Shelf iPSC-Derived Cell Therapies at Scale

A new and highly capitalized market player has boldly declared its debut as a developer of allogeneic, off-the-shelf iPCS-derived cellular therapeutics. GC Therapeutics (GCTx) has officially launched, bringing with it a revolutionary approach to cell therapy that aims to overcome current challenges in scalability, efficiency, and cost-effectiveness that have traditionally hindered the development of iPSC-derived therapies. With the debut of its innovative TFome™ platform, GCTx is positioned to scale the full potential of induced pluripotent stem cell (iPSC)-based therapies.

GMP Working Cell Banks to Accelerate MSC & Exosome Therapeutics into the Clinic

Save critical time and valuable resources while ensuring your path to clinical implementation by utilizing a consistent supply of high-volume, well-characterized working cell banks. Available from multiple tissues and donors, RoosterBio’s Xeno-Free CliniControl™ MSCs are manufactured in compliance with current Good Manufacturing Practices, supported by US FDA Type II Master Files, and designed to help you bypass the major costs and risks of GMP cell bank manufacturing.

Nucleus Biologics Launches NB-KUL™ DF: A DMSO-Free, Chemically-Defined Cryomedia Revolutionizing Cell and Gene Therapy Cryopreservation 

San Diego, CA, Oct. 15, 2024 – Nucleus Biologics, a leading provider of cell culture and bioprocessing solutions for the 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.

I Peace announces new iPSC lines to reduce immune rejection risk for U.S. population

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.

Cell X Technologies and Aspen Neuroscience collaborate to address throughput and scalability in manufacturing automation to facilitate iPSC cell processing

CLEVELAND, Ohio / SAN DIEGO, Calif. – October 8, 2024 – Cell X Technologies, pioneers in automated cell processing solutions, and Aspen Neuroscience, Inc., dedicated to autologous regenerative medicine, have entered into a collaboration and licensing agreement focused on providing an automated solution for Aspen’s iPSC-derived autologous clinical manufacturing. Cell X’s Celligent™ technology was developed to provide automated cell processing workflows, targeting efficiency gains and contributing to greater product understanding over current methods for GMP manufacturing of cell-based therapies. 

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.

ARCH Venture Fund XIII Secures a Staggering $3 Billion to Support Early-Stage Biotech Companies

On September 26th, ARCH Venture Partners announced it had closed ARCH Venture Fund XIII, a venture capital fund with over $3 billion to support the launch and growth of early-stage biotech companies. This fund builds on ARCH’s longstanding goal of investing in transformative healthcare solutions, with a focus on advanced therapies, AI, and cutting-edge solutions. Founded in 1986, ARCH Venture Partners has a history of supporting early-stage life sciences companies, particularly those focused on preventing, detecting, and curing diseases. Fund XIII’s investments include firms such as ArsenalBio, Metsera, Mirador Therapeutics, and Xaira Therapeutics.

EVerZom achieves first bioproduction of clinical grade stem cell-derived exosomes in large scale bioreactors in partnership with the French Blood Establishment (EFS) with unprecedented yields

Paris-Créteil, October 22nd, 2024 – EVerZom, a biopharmaceutical company developing exosome based biodrugs, announces that it has reached a key milestone in its development with the production of a first exosome GMP batch in a 10L bioreactor with unprecedented yields. Regulatory validation of the technology was carried out in GMP clean rooms of the Cellular Therapy and Engineering Unit of the French Blood Establishment (EFS) Ile-de-France in Créteil, a unit of reference for the bioproduction and quality control of Advanced Therapy Medicinal Product (ATMPs) and complex biologics.

PeptiGrowth Inc. is Launching a Novel Synthetic FGF2 Alternative Peptide (FGFR1c Agonist)

October 10, 2024 - PeptiGrowth Inc. (Headquarters: Chiyoda-ku, Tokyo; President: Jiro Sugimoto) has successfully developed a novel synthetic peptide called “FGF2 alternative peptide (FGFR1c agonist)”, which has equivalent function to recombinant FGF2 (Fibroblast Growth Factor 2, basic FGF (bFGF)). This product will be on the market at the beginning of October 2024.

Immunofluorescent Staining Within Hours, Not Days

October 8, 2024 - AMSBIO has launched CellO-IF – an all-in-one immunofluorescent staining reagent kit designed to accelerate the labelling organoids and spheroids directly in hydrogels or extracellular matrices, while preserving delicate structures and cellular integrity. Immunofluorescence (IF) allows detection and localization of antigens in diverse types of tissues in various cell preparations. The technique provides excellent sensitivity and amplification of signal by comparison to immunohistochemistry. However, traditional IF staining is a labor intensive, multi-step process. CellO-IF revolutionizes this by streamlining the procedure.

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. The AABB has recently released of a series of Certified Advanced Biotherapies Professional (CABP) exam prep bootcamps to help candidates prepare for AABB’s CABP exam. Developed by a diverse panel of credentialed CABPs and experts in the biotherapies field, each pre-recorded bootcamp focuses on one of the seven domains covered in the CABP exam. In addition, a bonus introduction bootcamp, “Getting Started with CABP,” is provided. 

HELP Therapeutics announces FDA clearance of IND application for universal iPSC-derived HiCM-188 cell therapy for the treatment of end-stage heart failure

NANJING, China, Oct. 22, 2024 — HELP Therapeutics Co. Ltd, a clinical-stage cell therapy company, 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.”

StemCyte’s HPC Cord Blood Receives RMAT Designation for Long COVID-19 Treatment

BALDWIN PARK, Calif., Oct. 3, 2024 — StemCyte announced that its Hematopoietic Progenitor Cell Cord Blood therapy (HPC Cord Blood) has officially obtained the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the treatment of Long COVID-19 syndrome. StemCyte is one of the few cell therapy companies in the United States to receive the FDA-granted RMAT designation.

RxCell Inc. Granted U.S. Patent for iPSC-based Cell Therapy

PARK CITY, Utah, September 19, 2024 – RxCell Inc. is pleased to announce the issuance of U.S. Patent 11,946,069 entitled “Method for Generating Multiple Cellular Products from Single Pluripotent Cell Source”, a significant advancement in the field of regenerative medicine. This patent, granted on April 2, 2024, provides RxCell with exclusive rights to iPSC-derived cells for therapy across a broad spectrum of diseases.

Poseida Therapeutics Receives RMAT for P-BCMA-ALLO1 to Treat Relapsed/Refractory Multiple Myeloma

SAN DIEGO, Sept. 16, 2024 — Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to P-BCMA-ALLO1, an investigational stem cell memory T cell (TSCM)-based allogeneic CAR-T cell therapy in Phase 1/1b clinical development for the treatment of patients with relapsed/refractory multiple myeloma.

FUJIFILM Cellular Dynamics Introduces Human iPSC-derived Sensory Neurons to Advance Pain Research

MADISON, Wis., September 10, 2024 – FUJIFILM Cellular Dynamics, a leading global developer and manufacturer of human induced pluripotent stem cells (iPSCs) today announces the global commercial launch of its human iPSC-derived iCell® Sensory Neurons for scientists engaged in neuroscience research, drug discovery of novel pain medications, and analysis of neurotoxicity side effects. FUJIFILM Cellular Dynamics will present iCell Sensory Neurons and other key products in its market-leading neuroscience portfolio at the Society for Neuroscience annual conference in Chicago from October 5-9, 2024 and the Annual Pain Therapeutics Summit in Boston from October 28-29, 2024.

South Korea’s SK bioscience Completes Acquisition of Germany’s CDMO IDT Biologika

SEONGNAM, South Korea, Oct. 2, 2024 — SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure, today announced the successful completion of its acquisition of a controlling stake in a German company, IDT Biologika, one of the top 10 global vaccine contract development manufacturing organizations (CDMO). In June 2024, SK bioscience has signed an agreement with Klocke Group, a German biopharmaceutical group, to acquire a controlling stake in IDT Biologika, Klocke Group’s affiliate.

CytoMed Therapeutics Acquires Cord Blood Banking License and 12,000 CBUs; Will Develop Cord Blood-derived Biologics through It Subsidiary, LongevityBank

SINGAPORE, Oct. 03, 2024 — CytoMed Therapeutics Limited (NASDAQ: GDTC) (“CytoMed” or “Company”), a Singapore-based biopharmaceutical company focused on harnessing its proprietary technologies to develop novel donor blood-derived, cell-based allogeneic therapies for the treatment of various cancers and aging-related diseases, has through its subsidiary, IPSC Depository Sdn Bhd, acquired the licence and certain assets of Cellsafe International Sdn Bhd (In Liquidation), a Malaysian cord blood bank.

Changing Dynamics in Umbilical Cord Blood and Tissue Banking

Cord blood is the blood that remains in the umbilical cord after the delivery of a newborn. It is a rich source of stem cells and immune system cells. During cord blood banking, these cells are isolated and cryopreserved for future use. The cells are collected from the two arteries and the vein which run along the length of the umbilical cord. The Wharton’s jelly is a gelatinous tissue that composes the umbilical cord, which also contains valuable therapeutic cells such as MSCs.

LifeCell International, India’s Largest Cord Blood Bank

LifeCell is India’s largest cord blood bank, offering stem cell banking services and diagnostic testing. Established in 2004, its BabyCord program is one of the largest cord blood banking programs in the region, with 50,000+ parents preserving newborn stem cells each year and 375,000 units cryopreserved.

What is CAR-T Cell Therapy? A New Way to Treat Cancer 

CAR-T cell therapy is as a type of immunotherapy that teaches T cells to recognize and destroy cancer. CAR-T cell therapy has demonstrated promising results across a range of patients across the globe. In some patients, it can lead to the total elimination of cancer. In others, there is a significant improvement of the disease. This guide answers the most common questions about CAR-T cell therapy for those who want to understand this novel technology platform for treating cancer. 

What Is An RMAT? List of Publicly Announced RMAT Designations (110)

To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded? The answer is that 110 RMAT designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 279 requests and issued 128, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 46% of RMAT applications get approved (128 approvals / 279 applications = 45.9%).

What Are iPSCs, Who is Funding Them, and What Trials are Underway?

Induced pluripotent stem cells (iPS cells) can be made by reprogramming mature adult cells back into an embryonic-like state. Derived from skin or blood cells, iPS cells are not controversial, because they are made from adult cells. As pluripotent stem cells, they can give rise to all of the tissues that form the human body. Induced pluripotent stem cells are a fascinating cell type with enormous therapeutic potential. Let’s dive into everything you need to know about iPS cells and their diverse applications.

Leading iPSC Mass Production Equipment Manufacturers 

Induced pluripotent stem cells (iPSCs) represent a groundbreaking advancement in biotechnology. iPSCs are a type of pluripotent stem cell generated by reprogramming adult somatic cells to an embryonic-like state, allowing them to differentiate into virtually any cell type in the body. This innovative technology provides a powerful tool for regenerative medicine, disease modeling, and drug discovery by offering a patient-specific source of cells for research and therapeutic applications.

Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials, & Trends, 2024

This report describes the state of CAR-T cell therapies and explores their future potential. It reveals all known CAR-T product approvals worldwide and the number of patients treated annually with each, as well as presents the products in late-stage trials. It reveals market size figures for the Global CAR-T Cell Therapy Market, segmented by Product, Geography, and Indication, with future forecasts through 2032. It identifies and quantifies CAR-T funding events, including licensing deals, collaborations, financing rounds, IPOs, and M&A transactions. It presents rates of scientific publications, patents, grants and clinical trials, as well as identifies the core products and technology platforms of 74 leading competitors. This week only, you can become immediately informed for 20% off.

[FLASH SALE] Global Database of Exosome Companies, 2024

In recent years, exosomes have been gaining momentum as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering cells to patients. With at least 34,824 scientific articles published about exosomes and at least 416 clinical trials, these small vesicles have intriguing potential to be used across a range of therapeutic applications. This database features all known companies worldwide who specialize in developing exosome and extracellular vesicle (EV) therapies, diagnostics, and platform technologies. For the next 48 hours only, you can claim this database for $150 off. 

Interested to learn about other market segments, such as MSCs, iPSCs, CAR-T cells, exosomes, cord blood and tissue, or the cell therapy industry at large? 

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