Fujifilm Investing $200M to Expand CDMO Services and Double Capacity for iPSC-derived Therapeutics

December 4, 2023, TOKYO, Japan – FUJIFILM Corporation has announced the investment of USD 200 million in two subsidiaries to significantly expand its global cell therapy contract development and manufacturing (CDMO) capabilities. The investment will enable Fujifilm to support the expanding cell therapy market which is anticipated to grow by more than 30% per year. The $200M investment is earmarked for both the new headquarters of FUJIFILM Cellular Dynamics, a leading developer and manufacturer of human iPSCs and iPSC-derived cells, and the California site of FUJIFILM Diosynth Biotechnologies, a world-leading CDMO in biologics and advanced therapies.

Spend Less Time Culturing Cells with Made-to-Order hMSCs

Leverage RoosterBio’s manufacturing expertise to ensure consistency in your key raw cellular starting material. QuickShip hMSCs are manufactured from your selected tissue and donor and using highly reproducible MSC production systems. Define the total quantity of hMSCs you need, preferred manufacturing platform, desired passage, and vial attributes, then RoosterBio will make and characterize cell banks to meet your specifications. Whether you need millions or billions of hMSCS, you can spend less time culturing cells and more time generating data.

Core Biogenesis and Nucleus Biologics Announce Strategic Collaboration for Manufacturing and Distribution of Cost-Effective and Sustainable Recombinant Proteins

San Diego, CA, Jan 10, 2024 – In an effort to provide lower cost & more defined reagents and media to the cell and gene therapy market, Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media solutions for the cell and gene therapy industry, signed a manufacturing, distribution, and collaboration agreement with Core Biogenesis, an innovator in the field of recombinant human proteins expressed in plants. This agreement makes Nucleus Biologics the GMP manufacturer for Core Biogenesis’ recombinant proteins and a distributor for the cell and gene therapy market. Nucleus Biologics, along with their sister company Stoic Bio, will make these recombinant proteins available for their Krakatoa™ pod-based media manufacturing systems.

Waisman Biomanufacturing & RoosterBio Announce Collaboration for GMP Manufacturing of Cell & Exosome Therapies

Madison, WI, February 6, 2024 — Waisman Biomanufacturing, a leading CDMO which is part of the University of Wisconsin Madison, announced a strategic partnership with RoosterBio, Inc., a leading provider of human mesenchymal stem/stromal cells (MSCs), highly engineered media solutions, and bioprocess development services. Through this collaboration, Waisman Biomanufacturing will incorporate RoosterBio’s cutting-edge MSC and exosome bioprocessing products, manufacturing protocols, and analytical services into its portfolio of biologics manufacturing services, expanding Waisman Biomanufacturing’s capabilities for the production of advanced therapies for clinical trials.

Pluri Inc. Launches the Latest Global Cell Therapy CDMO, PluriCDMO™

HAIFA, Israel, Jan 08, 2024 – Pluri Inc. (Nasdaq: PLUR) (TASE: PLUR), a leading biotech company that transforms cells into solutions that promote global wellbeing and sustainability, today announced it has launched a new business division offering cell therapy manufacturing services as a Contract Development and Manufacturing Organization (CDMO): PluriCDMO™.

RESILIÉLLE COSMETICS LLC Unveils Exosome Results of First-Ever 100-Person Trial on Age Zero Exosome Cosmetic Serum Applied Topically Post Microneedling

Rochester NY, February 13,  2024 – RESILIÉLLE^TM Cosmetics LLC, a leader in innovative skincare solutions, announces the successful completion of the world’s first 100-person microneedling-plus-exosome trial, conducted at eight renowned medspas across the country. The clinicians participated in the trial in order to analyze what is the most effective amount of RESILIÉLLE Age Zero Exosome^TM topical serum to be applied after facial microneedling.

Cord Blood Registry® (CBR®) by CooperSurgical® and Fulgent Genetics Launch Innovative Genetic Testing

TRUMBULL, Conn. and EL MONTE, Calif. — CooperSurgical^®, a global leader in fertility and women’s health, and Fulgent Genetics, Inc. (NASDAQ: FLGT), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced that they have partnered to offer families of Cord Blood Registry^® (CBR^®) exclusive newborn genetic screening panels.

ExoXpert, a CDMO launched by EXO Biologics to service increasing worldwide demand for exosomes

Liege, Belgium – EXO Biologics SA, a Belgian biotech company committed to developing biopharmaceuticals using exosomes to treat rare diseases with high unmet medical needs, today announces the worldwide launch of ExoXpertTM, a contract development and manufacturing organization (CDMO) specializing in exosomes. ExoXpert offers a MSC-based exosome manufacturing platform used in European clinical trials. ExoXpert is a wholly owned subsidiary of EXO BiologicsTM.

BioCentriq® Strengthens Cell Therapy CDMO Services with $29.2M in Capital Investment

NEWARK, N.J., — BioCentriq®, a global cell-based therapy Contract Development and Manufacturing Organization (CDMO), proudly announces the successful completion of its latest round of fundraising, securing $29.2M in capital investment. The funding round marks a significant milestone in BioCentriq’s mission to accelerate delivery of innovative cell therapies by translating, optimizing, and scaling processes for GMP manufacture.

FUJIFILM Cellular Dynamics and Opsis Therapeutics Announce License with BlueRock Therapeutics for iPSC-derived Retinal Cell Therapy Candidate 

MADISON, WI, January 23, 2024 — FUJIFILM Cellular Dynamics, a leading global developer and manufacturer of human iPSCs, and Opsis Therapeutics, a joint venture of FUJIFILM Cellular Dynamics, and co-founder David Gamm, M.D., Ph.D., focusing on developing cell therapies for patients with ocular diseases, announced an agreement granting BlueRock Therapeutics an exclusive, worldwide license to develop and commercialize an iPSC-derived cell therapy candidate for the treatment of human retinal diseases. BlueRock Therapeutics, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG, exercised its option to exclusively license OpCT-001, an iPSC-derived photoreceptor cell therapy for human retinal diseases.

AVANT BIO Emerges as a Leading Equity Firm in Life Sciences, Tech Bio, and HealthTech

NEW YORK — AVANT BIO LLC, a pioneering early stage and growth equity firm, announces its official launch, positioning itself at the forefront of today’s transformative landscape in life sciences, tech bio, and healthtech industries.  The Firm’s investments align with the convergence of groundbreaking technologies and an enhanced understanding of biology, creating a powerful synergy poised for breakthrough advancements in the future.

Charles River Collaborates with Pluristyx, Expanding its Portfolio of Human Pluripotent Stem Cells

WILMINGTON, Mass., February 20, 2024 – Charles River Laboratories International, Inc. (NYSE: CRL) announced that it has entered into an agreement with Pluristyx Inc., a leading provider of tools, technologies, and services for the development of cell therapies. The collaboration provides Charles River with broad access to highly characterized and unique stem cell lines, including high-quality embryonic stem (ES) cells and induced pluripotent stem cells (iPSCs) as research tools to support development of new therapeutics.

Launch of the National Cord Blood Network to Optimize Life-Saving Treatment with Cord Blood Transplantation in Hematologic Malignancies

CLEVELAND, February 23, 2024 — The National Cord Blood Network (NCBN) proudly announces its official launch, signaling a new era of advances and collaboration in cord blood transplantation. The NCBN aims to increase accessibility to life-saving cord blood transplantation for patients with hematologic malignancies in US Transplant Centers as well as optimize cord blood transplant practices.

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.

The Present and Future Trajectory of the Cord Blood & Tissue Banking Market

Umbilical cord blood (UCB) has been an accepted source of hematopoietic stem cells (HSC) for transplantation for more than 30 years. Umbilical cord-derived stem cells are the youngest cells available for transfusion and yet their uptake lags behind bone marrow and peripheral blood-derived HSCs. Decreased engraftment rates and the low cell dose available for transplantation are limitations that are preventing umbilical cord blood-derived cells from reaching their full potential. While a handful of companies are now developing cord blood and tissue-derived cell therapeutics, it will likely take several years for these products to reach commercialization.

Allogeneic iPSCs Gaining Momentum Due to Ease of Access and Economies of Scale

While autologous iPSC-based cell therapies are patient-specific, allogeneic iPSC-based cell therapies use donor-derived cells as a starting material. In recent years, a greater number of allogeneic iPSC-derived cell therapies are being studied than autologous therapies. One of the advantages of allogeneic therapy is that a large number of doses can be generated simultaneously from a single batch of iPSCs and banked.

Induced Pluripotent Stem Cell (iPSC) Industry Trends Dominating in 2024

Induced pluripotent stem cells (iPS cells or iPSCs) are laboratory-made pluripotent stem cells that are produced using non-controversial adult cells. They are derived from somatic cells through reprogramming and turning on the expression of specific pluripotency genes. This reprogramming can be achieved using different techniques with varying efficiencies.

The Pipeline for iPSC-Derived Cell Therapeutics in 2024

Despite progress involving the use of iPSCs in disease modeling and drug discovery applications, it will be a long path to achieve their broad-scale use in patients. Within a preclinical context, cell types differentiated from iPSCs are tested for their therapeutic response. Then, clinical trials are conducted to assure that essential parameters, such as tumorigenicity, dose toxicity, and immunogenicity, are assessed before authorizing the product for use in human patients. iPSC-derived cells have the potential to be used as therapies for treating cardiovascular, neurological, and metabolic diseases, as well as for repairing damaged cells, tissues, and organs. 

[NEW] CAR-T Financing Report - Venture Capital, IPOs, Licensing Deals, Collaborations, and M&A Transactions, 2024

Worldwide, hundreds of companies are engaged in developing CAR-T products and therapies. These CAR-T therapy companies have developed nearly 970 early and late-stage therapies. These companies have also signed an incredible 98 collaboration deals to progress the development of various CAR-T product candidates. Within this nascent industry, with over 417,801 patent records and 4,024 granted patents, large pharma has increasingly been seeking to enter the CAR-T field by licensing rights from existing patent owners. Among the various financing types analyzed in this report—which include CAR-T industry IPOs, licensing deals, strategic partnerships (collaborations), and M&A deals—M&A deals constitute the largest financial percentage, accounting for nearly $100B in transactions.

Global Induced Pluripotent Stem Cell (iPSC) Industry Report - Market Size, Trends, and Forecasts

In addition to those who are developing iPSC-derived cell therapeutics, there are an ever-growing number of  competitors who are commercializing iPSC products for use across a diverse range of applications. These applications include drug development and discovery, disease modeling, toxicology testing, and personalized medicine, as well as tissue engineering, 3D bioprinting, and clean meat production. This report reveals all major iPSC market competitors worldwide and presents a market size breakdown for iPSCs by Application, Technology, Cell Type, and Geography (North America, Europe, Asia/Pacific, and RoW). Importantly, it also presents future market projections through 2030.

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? 

Explore the BioInformant Shop.

*Want to advertise in this newsletter? Contact us at Info@BioInformant.com.