New CO.DON Plant for the EU-approved Advanced Therapy Cartilage Regeneration Treatment Sets a Milestone in Cell Therapy for Commercial Manufacturing

Human cell experts from Germany’s CO.DON AG are again cutting the edge: they have launched human cells production on an industrial scale. The demanding quality standards required of the manufacturing conditions for human cell transplants led to the development of Integrated Isolator Technology (IIT) alongside industrial partners, which went into operation at CO.DON´s Teltow site in 1999. Now CO.DON has taken the next step using all their experience as human cell experts: A plant for the industrial-scale production of human cells in Leipzig.

The French Blood Agency announces agreement with TreeFrog Therapeutics to scale-up manufacturing of iPS-derived hematopoietic stem cell transplants

The French Blood Agency (EFS) and TreeFrog Therapeutics announce a partnership to advance the mass-production of iPSC-derived HSC transplants based on a patented differentiation protocol developed by the EFS (UMR S938), the Institute for Radioprotection and Nuclear Safety (IRSN) and Sorbonne University. Under the terms of the agreement, TreeFrog Therapeutics will demonstrate its proprietary C-Stem^TM technology enables the production of large batches of iPSC-derived HSCs in industrial bioreactors with clinical-grade quality and reduced costs compared to 2D culture.

Burgeoning Number of iPSC Therapies to Be Tested in Clinical Trials

Therapeutic applications of induced pluripotent stem cells (iPSCs) have surged in recent years. Since the discovery of iPSCs in 2006, it took only seven years for the first iPSC-derived cell product to be transplanted into a human patient in 2013. From 2013 to present, a rising number of clinical trials and physician-led studies employing human iPSC-derived therapeutics have been initiated across multiple geographies worldwide.

Invitrx Therapeutics to Co-Sponsor Baylx, Inc’s US FDA Approved Umbilical Cord Tissue Mesenchymal Stem Cells Product for COVID-19

Irvine, CA., November, 23 2020 — Invitrx Therapeutics has formally signed a joint venture agreement with Baylx, Inc. (Baylx), to co-sponsor Baylx’s FDA approved Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with COVID-19.

EVerZom raises €1.1M to industrialize its exosome biomanufacturing platform

Paris, November 30, 2020 — EVerZom, a biopharmaceutical company specialized in the bioproduction of exosomes, announced that it has raised €1.1 million in funding from institutional and private investors to develop its exosome bioproduction platform. This funding will speed up the platform development and scale-up, with the objective to allow routine clinical grade production by 2022.

Performance Cell Manufacturing, CDMO Division of VetStem Biopharma

Poway, California, December 8, 2020. – Performance Cell Manufacturing (PCM), is the newly formed contract development and manufacturing organization (CDMO) division of VetStem Biopharma. PCM was born from VetStem’s 15 years of experience with cGMP compliant cell therapy product development and manufacturing. PCM provides cell therapy development and cGMP contract manufacturing for companies for FDA phase 1 and phase 2 clinical trials.

Patent Analysis for the Global Induced Pluripotent Stem Cell Industry

iPSCs have numerous applications related to basic research, drug screening, toxicological studies, disease modeling, cell therapy and personalized medicine. Since 2006 when Kyoto University filed its first patent application for iPSCs, iPSC patents have expanded dramatically. While there are regional differences, common areas of focus include genetically engineered cells, drug screening technologies, and disease-specific cell technologies. Currently, the U.S. is the largest target market for pluripotent stem cell (PSC) technology, with more than 2,850 patent families filed. 

Organicell Announces Additional Site for Phase I/II Clinical Trial of Zofin™ for Treatment of COVID-19 

Miami, FL (November 18, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that it is now enrolling patients at an additional site, Larkin Hospital North located in Hialeah, Florida for its Phase I/II clinical trial for the use of its Zofin™ therapeutic in treatment of COVID-19.

Trailhead Biosystems Raises $6.6 Million in Series A Financing

CLEVELAND, Ohio, November 10th, 2020 - Trailhead Biosystems – a biotechnology company pioneering the application of machine-enabled science towards understanding and controlling biology – announced its $6.6 million Series A financing. The company has developed a proprietary platform to perform systems-level interrogation of complex biological problems, ranging from the generation of industrially-scalable manufacturing conditions for specialized human cells to combinatorial drug discovery in cancer and anti-viral therapies.

Proteintech and HebeCell to Collaborate on Nanobody iPSC-derived NK Cells

CHICAGO & NATICK, Massachusetts, Nov 11, 2020 – Proteintech and HebeCell  announce their collaborative partnership to develop proprietary nanobody based chimeric antigen receptor (nCAR) technology for the development and commercialization of iPSC-derived natural killer (iPSC-nCAR-NK) cells, a promising cellular immunotherapy treatment for cancer and other diseases.

FUJIFILM Cellular Dynamics and Lonza agree to expand the availability and use of induced pluripotent stem cell technology

MADISON, Wis., and WALKERSVILLE, Md., November 12, 2020 — FUJIFILM Cellular Dynamics, Inc., a leading global developer and manufacturer of human induced pluripotent stem cells (iPSC) technologies, and Lonza Walkersville, Inc. (Lonza, a leading global GMP iPSC manufacturer), have entered into a worldwide agreement. The agreement enables drug developers to leverage both companies’ expertise and technologies for the generation of iPSCs through licensing agreements.

Gamida Cell and Be The Match BioTherapies® Expand Strategic Collaboration

Gamida Cell Ltd. (Nasdaq: GMDA), a leading cellular and immune therapeutics company, and Be The Match BioTherapies^®, an organization offering solutions for companies developing and commercializing cell and gene therapies, announced an expansion of their existing strategic collaboration for omidubicel, Gamida Cell’s advanced cell therapy in Phase 3 clinical development as a potentially life-saving treatment option for patients in need of an allogeneic hematopoietic stem cell (bone marrow) transplant.

StemBioSys and Cartox Announce Publication of Research Demonstrating CELLvo(TM) Matrix Plus Significantly Enhances the Functionality of hiPSC Cardiomyocytes

SAN ANTONIO and ANN ARBOR, Mich., Nov. 9, 2020 — StemBioSys, Inc. (StemBioSys) and CarTox, Inc. (Cartox) announced the publication of research in Nature Scientific Reports demonstrating that CELLvo™ Matrix Plus, an extracellular matrix (ECM) technology derived from human perinatal stem cells, supports rapid functional and structural maturation of human induced pluripotent stem cell derived cardiomyocytes (hiPSC-CMs) in culture and enables high throughput cardiotoxicity screening using mature human cardiomyocytes.

Novartis Snags Exclusive Rights from Mesoblast for MSC Therapy Against COVID-Induced ARDS

Basel, November 19, 2020 — Novartis announced that it entered into an exclusive worldwide license and collaboration agreement with Mesoblast to develop, commercialize and manufacture remestemcel-L for the treatment of acute respiratory distress syndrome (ARDS), including that associated with COVID-19. ARDS is an area of significant unmet need, with an approximate 40% mortality rate with current standard of care, which includes prolonged ICU treatment and mechanical ventilation.

Ushering in the Era of CAR-T: Kymriah, Yescarta, and Tecartus

Since the approval of the first CAR-T cell therapeutics in 2017, widespread research, an exponential increase in clinical trial activity, proliferative M&A activity, and lucrative IPOs have created a robust CAR-T cell market. This billion dollar market would not have been possible without the remarkable efficacy of Kymriah, Yescarta and Tecartus in treating several types of blood cancers.

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