Feature Image (Source): Believer Meats 

BELIEVER Meats Breaks Ground on Largest Cultivated Meat Production Facility in The World

WILSON, N.C. and REHOVOT, Israel, Dec. 7, 2022 – BELIEVER Meats, a leading pioneer of the cultivated meat industry, officially broke ground today on its first U.S. commercial facility in Wilson, North Carolina. Once operational, the 200,000-square-foot facility will be the largest cultivated meat production center in the world with the capacity to produce at least 10,000 metric tons of cultivated meat, without the need to slaughter a single animal. This is a watershed moment for the cultivated meat industry that will allow BELIEVER Meats to meet growing demand for decades to come.

GOOD Meat, the World’s First-to-Market Cultivated Meat Company, Receives U.S. FDA Clearance

ALAMEDA, Calif.–GOOD Meat, the cultivated meat division of food technology company Eat Just, Inc., announced it has received a “no questions” letter from the U.S. FDA as part of one of the agency’s first pre-market consultations for a new kind of meat, poultry and seafood made from cells instead of raised and slaughtered animals. The letter means that following a careful and rigorous evaluation, the FDA has accepted the company’s conclusion that its first poultry product, cultivated chicken, is safe to eat.

Application Highlight: Mycap® CCX Processing Offers Safe Gravimetric Workflow

Mycap®️ CCX serves for expansion of suspension cell culture from cell banks to seed bioreactor. The expansion process is performed through multiple passages of successively larger Erlenmeyer flasks and involves the aseptic transfer of media and/or inoculum between donor and recipient flasks and the amount is gravimetrically measured. Using this system eliminates the need to work in a biosafety cabinet for media or inoculum transfer since the flask cap does not have to be removed for fluid transfer during passaging or sampling. Learn more by downloading this informative application highlight.

300+ LNP Experts Uniting in Boston Next Month to Accelerate Next Generation LNP End-To-End Development

With LNPs dominating the 2023 biopharma market, at the 2nd LNP Formulation & Process Development Summit, we are addressing the hottest topics, and most pressing questions faced in the LNP world – its potential beyond mRNA vaccines. 60+ speakers include Intellia Therapeutics, Arbor Biotechnologies, ReCode Therapeutics, Capstan Therapeutics & more. With less than 4 weeks to go, make sure you don’t miss 3 days of networking with LNP Biology, Chemistry, Formulation & Process Development, Tech Ops & Manufacturing experts to gain a competitive advantage to exploit LNP potentials! Find out more here.

Center for Breakthrough Medicines, Nucleus Biologics, and Stoic Bio Announce Strategic Collaboration for Steady Supply of Quality Controlled Cell Culture Media to Expedite Development of Cell and Gene Therapies

March 7, 2023, SAN DIEGO, CA — In a joint effort to accelerate high-quality therapies to market, Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media solutions for the cell and gene therapy industry, and Stoic Bio, a provider of sustainable technology for cell media manufacturing, have announced plans for a supply agreement with the Center for Breakthrough Medicines (CBM), a leading CDMO whose mission is to save lives by accelerating the development and manufacture of advanced therapies. This agreement makes Nucleus Biologics the preferred supplier of cell culture media and other critical biological solutions for CBM; thus, ensuring a steady, consistent supply of this critical material with tighter quality control measures.

Ronawk Brings On Dr. David S. Zamierowski As New Member of the Board of Directors

March 10, 2023, Olathe, KS – Ronawk, a biotech and biofabrication company powered by the Bio-Block Universe™, is pleased to announce the appointment of Dr. David S. Zamierowski to its Board of Directors. Dr. Zamierowski has a storied career as both a Plastic Surgeon and Inventor. He has developed countless advancements in many areas of life science.

Cellular Engineering Technologies Receives Exclusivity to Use John Paul II Medical Research Institute’s Immortalized Human Stem Cells for Commercial Bio-Production Applications

March 8, 2023, Coralville, Iowa – Cellular Engineering Technologies, Inc. (CET), a biotech company specializing in cell manufacturing and contract research services, has received exclusivity to use immortalized human stem cells from the John Paul II Medical Research Institute (JP2MRI). The immortalized stem cells were created by gene editing human stem cells to produce next gen human cells with more native PTM than existing cell lines which are currently being used in bio-production applications. The cell lines will be better able to produce native drug targets and high-end human growth factors necessary to improve the efficacy of iPSC therapies. 

iPSirius Granted Second American Patent for Innovative IPVAC Cancer Vaccine Technology

Paris, March 7 2023 – iPSirius, a leading biotechnology company focused on the development of innovative immunotherapies, announced that it has been granted its second American patent for a novel technology that enables the production of ‘off-the-shelf’ cancer vaccines from induced pluripotent stem cells (iPSCs). The newly granted patent covers the proprietary methods developed by iPSirius for the production of their proprietary IPVAC off-the-shelf cancer vaccines.

The European Innovation Council (EIC) awards the AcouSort project AcouSome SEK 26 million to develop groundbreaking technology for exosome-based diagnostics

August 13, 2022, Lund, Sweden – Exosomes are nanoparticles that enable human cells to communicate vital information with each other. They have potential to open a completely new field within diagnostics, as they can give us ‘status reports’ on organs such as the brain and heart, as well as give us vital information on tumor diseases, infectious diseases, pregnancy and stem cell conditions. EIC has announced that it granted AcouSort and its project partners SEK 26 million to develop an acoustofluidic thin-film actuated chip for exosome separation from blood. Of the SEK 26 million, SEK 12.2 million will go to AcouSort, and the remainder of the funding will be distributed to AcouSort’s partners Lund University, DTU, and Day One. 

American Academy of Stem Cell Physicians To Hold Board Examination at Upcoming Annual Meeting

MIAMI, February 26, 2023 – The Board of American Academy of Stem Cell Physicians is the official board certifying body of the American Academy of Stem Cell Physicians. (AASCP). As a nationally recognized academy with a mission to bring like-minded physicians together to increase awareness and education of regenerative medicine, the AASCP is proud to announce the Fellowship and Diplomat certification. If you are interested in pursuing board certification in regenerative medicine, please contact the AASCP at 305-866-8384 or visit AASCP.net.

Ryne Biotechnology Wins $4M from CIRM to Develop RNDP-001, an iPSC-Derived Dopamine Neuron Progenitor

February 14, 2023, San Diego, CA — Ryne Biotechnology, a therapeutics company leveraging iPSC technology to discover and develop a platform of off-the-shelf neuron replacement therapies for neurological disorders, announced that the California Institute for Regenerative Medicine (CIRM) has awarded the company a $4 million Clinical Stage Research Program (CLIN1) grant. This funding will enable the company to advance its lead candidate RNDP-001, an iPSC-derived dopamine neuron progenitor for the treatment of both inherited and idiopathic forms of Parkinson’s disease, through submission of an Investigational New Drug (IND) application within the next 12 months.

EV Biologics Generates Mesenchymal Stem Cell Lines

TAMPA, FL, February 21, 2023 – EV Biologics Corp (OTC PINK:YECO), announced that it has successfully generated several mesenchymal stem/stromal cell (MSC) lines for secretome production and further cell line development. The cell banks were isolated from rigorously screened human donor tissue using xeno-free, serum-free culture media for isolation and expansion, after obtaining informed consent (from donors) for research and development. Analysis of the cell lines confirmed their identity as MSCs according to established criteria.

$3.0m CRC-P grant to VivaZome Therapeutics and Partners for Customised Exosome Therapy

19 January 2023, Melbourne, Australia – VivaZome Therapeutics Pty Ltd (“VivaZome”) is delighted to announce that it has been awarded an Australian Government Round 13 CRC-P grant of $3.0m in support of the project “Customised exosomes – the future of regenerative medicine”.

Exosome Company Spotlights from "A" to "Z"

Today, a rapidly growing number of companies are developing exosome-based products. The list below presents all known companies worldwide that are developing exosome therapeutics or diagnostics. It also describes the innovative technologies they are developing. This list has grown substantially in recent months, as numerous companies have reached out to us request inclusion in this widely shared "master list" of exosome companies worldwide.  

Heartseed and Novo Nordisk Dose First Patient with HS-001, an iPSC-Derived Cell Therapy to Treat Heart Failure

Tokyo, Japan and Bagsværd, Denmark, 10 February 2023 – Heartseed Inc. (Heartseed) and Novo Nordisk A/S announced that Heartseed has successfully dosed the first patient in a phase 1/2 clinical study (LAPiS Study) with HS-001 – an investigational cell therapy for heart failure. An independent safety evaluation committee has evaluated 4-week data on the patient, who lives with advanced heart failure and has given approval for the study to continue.

The Pipeline for iPSC-Derived Cell Therapeutics in 2023

Despite progress involving the use of iPSCs within disease modeling and drug discovery applications, it will be a long path to achieve the broad-scale use of iPSC-derived cell types in human 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. 

Interview With Kaz Hirao, President & COO at Fujifilm Cellular Dynamics

Fujifilm Cellular Dynamics is the largest provider of induced pluripotent stem cell (iPSC) products worldwide. In addition to being a global leader for life science products, the company divided into two business units (Life Science and Therapeutics), positioning it to further invest in the development of iPSC-derived cell therapeutics. The company also opened a $21M cGMP production facility to support its internal cell therapeutics pipeline, as well as serve as a CDMO for iPS cell products.

Behind the Scenes at FUJIFILM Irvine Scientific (FISI) with Yutaka Yamaguchi (President)

FUJIFILM Irvine Scientific (FISI) is the world’s leading manufacturer of cell culture media, reagents, and medical devices that are used across the cell therapy, regenerative medicine, assisted reproductive technology, and industrial cell culture markets. The company adheres to ISO and FDA regulations and operates dual cGMP manufacturing facilities in California, USA, and Tokyo, Japan. In this interview with Yutaka Yamaguchi, President of FISI, we explore the reasons for FUJIFILM’s acquisition of Irvine Scientific, the importance of the company’s dual manufacturing facilities, traits that differentiate FISI from its competitors, and trends within the regenerative medicine industry at large.

List of Publicly Announced RMAT Designations (74)

To date, how many U.S. FDA approved RMATs have been issued and to whom have they been awarded? The answer is that 74 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced. However, the FDA states it has received 210 requests and issued 82, 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 39% of RMAT applications get approved (82 approvals / 210 applications = 39.0%).

[FLASH SALE] Global Database of Cell and Gene Therapy CDMOs, 2023

Continuously updated, this global database reveals the identities of CDMOs that specialize in the the manufacture of cell therapies, gene therapies, and exosome therapeutics, specifically. If you are a cell or gene therapy developer, you can use it to identify potential manufacturing partners. If you are a contract manufacturer, you can use it to identify the depth and breadth of your market competition. For a limited-time only, you can claim it for 50% off.

[FLASH SALE] Global Database of CAR-T Cell Therapy Companies, 2023

As far as we can tell, this is the world’s only searchable, sortable database of CAR-T cell therapy companies worldwide that is publicly available. Unsurprisingly, it takes our analysts countless hours of research to uncover these CAR-T cell therapy companies worldwide, as well as to translate websites and clinical trial programs across dozens of languages. Thankfully, we have a talented, multilingual team who is up to the task. Because we continuously update this database to reflect new competitors entering the CAR-T cell therapy marketplace, we are confident that you will find it to be invaluable resource. For a limited-time only, you can claim it for 50% off.

To access other market insights about CAR-T cell therapy, MSCs, iPSCs, cord blood, and beyond, explore the BioInformant Shop.

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