FUJIFILM Corp.

Welcome to Endpoints News’ manufacturing briefs, where we bring you essential news on new builds, collaborations, recalls and more. Coherus is resuming the supply of its Neulasta biosimilar after issues at a third-party labeling and packaging contractor caused delays in October. Production will resume this week. It has a backlog of around 120,000 units. Coherus first warned of supply delays in September. The biosimilar, branded as Udenyca, is approved to reduce infection in patients with low white blood cell count. Novavax has ended its Covid-19 vaccine supply agreement with the UK, the company said on Wednesday. The vaccine maker will return $10.3 million in quarterly installments over the next three years, totaling $123.8 million. Akebia Therapeutics disclosed in its third-quarter report that it has several ties with WuXi STA, a subsidiary of WuXi AppTec. The company has two contracts with WuXi and has the option to give 180 days notice to terminate them for any reason. One of the contracts ends in 2029 and the other in 2032. Charles River Laboratories reported a 1.6% drop in its total revenue for the third quarter of 2024 to $1.01 billion. But its manufacturing business increased 12% to $196.9 million because of heightened demand for its cell and gene therapy services, CEO James Foster said in an earnings call Wednesday. Charles River makes Vertex Therapeutics’ cell therapy Casgevy. The World Health Organization and its member states have allocated 899,000 doses of mpox vaccines to nine African countries. Around 85% of the doses will be supplied to the Democratic Republic of the Congo, which has the highest number of infections, according to a Wednesday release. CDMO AmplifyBio secured $50 million from investment capital provider Vitrian to bolster its manufacturing facility in New Albany, OH, according to a Tuesday release. Accord Healthcare received £50 million ($64.9 million) from the UK government to expand its facility in Fawdon, Newcastle upon Tyne, the company said Friday . It will build new manufacturing lines for an unnamed cancer drug and two autoimmune injectables. Around 50 new jobs will be added. Fujifilm Diosynth Biotechnologies has started the first phase of its factory expansion in Hillerød, Denmark, which will include adding six mammalian cell bioreactors, the company said Tuesday. The overall plan will be completed and operational by 2026. It will increase the facility to 51,500 square meters and add 2,200 new jobs. FujiFilm also said it signed a commercial manufacturing agreement with TG Therapeutics to make its therapy for relapsing forms of multiple sclerosis, according to a Monday announcement. Fujifilm will make Briumvi in Holly Springs, NC, which will be fully operational in 2025. Briumvi was FDA approved in December 2022. Evotec has sold an API manufacturing site in Halle, Germany, to Munich-based private equity firm Monacum Partners, the company said Tuesday. No financial details were disclosed. The CDMO Scorpius Holdings is partnering with Celltheon so it can offer cell line development and antibody discovery to its customers, according to a Monday announcement.

CAMBRIDGE, MA USA I September 3, 2024 I BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. “We are pleased with the immense progress we have made to date and thrilled that the FDA has cleared our IND application to initiate clinical testing for OpCT-001,” said Amit Rakhit, Chief Development and Medical Officer at BlueRock Therapeutics. “We believe that OpCT-001 has potential to restore vision in people living with primary photoreceptor diseases and look forward to working with the ophthalmology community in initiating our Phase 1/2a clinical study.” OpCT-001 is the first investigational iPSC-derived cell therapy to be clinically evaluated for the treatment of primary photoreceptor diseases. Initiation activities to support a Phase 1/2a study are underway. The Phase 1/2a study is designed as a first-in-human study to evaluate the safety and tolerability of subretinal administration of OpCT-001 in people with primary photoreceptor diseases as well as evaluate the effect of OpCT-001 on retinal structure, visual function and functional vision. The study will assess several dose levels of OpCT-001 and is expected to enroll participants in sites across the U.S. Primary photoreceptor diseases are a subgroup of inherited retinal disorders that includes retinitis pigmentosa and cone-rod dystrophy. These diseases affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in both children and adults. Primary photoreceptor diseases affect an estimated 110,000¹ people in the U.S. and only limited treatment options exist for this population. OpCT-001 aims to restore vision loss caused by these diseases by replacing degenerated cells in the retina with functional cells. OpCT-001 was exclusively licensed from FUJIFILM Cellular Dynamics and Opsis Therapeutics in January 2024 as part of the strategic R&D and clinical manufacturing collaboration between BlueRock Therapeutics, FUJIFILM Cellular Dynamics, and Opsis Therapeutics forged in 2021. As part of the collaboration, FUJIFILM Cellular Dynamics supported BlueRock Therapeutics via research, development and the execution of critical IND-enabling activities including the clinical manufacturing of OpCT-001 at their cGMP² facility in Madison, Wisconsin. OpCT-001 is an investigational cell therapy that has not been approved by any regulatory authority, and its efficacy and safety have not been established or fully evaluated. ¹https://www.ncbi.nlm.nih.gov/books/NBK519518/ ; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1808442/ ; https://www.nidcd.nih.gov/health/usher-syndrome#b ²Current good manufacturing practices are regulations enforced by the FDA. About BlueRock Therapeutics LP BlueRock Therapeutics LP is a clinical stage cell therapy company focused on creating cellular medicines to treat devastating diseases. We are harnessing the power of cell therapy to create a pipeline of new medicines for people suffering from neurological, ophthalmic, cardiovascular and immunological diseases. Two of our novel investigational cell therapies, bemdaneprocel (BRT-DA01) for the treatment Parkinson’s disease and OpCT-001 for the treatment of primary photoreceptor disease are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the U.S. FDA (Food and Drug Administration); has completed Phase 1 clinical trial and is progressing to the next stage of clinical development. OpCT-001 has been cleared by the FDA to begin Phase 1 clinical testing. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. In late 2019, BlueRock became a wholly owned, independently operated subsidiary of Bayer AG as a cornerstone of its newly formed Cell & Gene Therapy platform. Our culture is defined by the courage to persist regardless of the challenge, the urgency to transform medicine and deliver hope, integrity guided by mission, and community-mindedness with the understanding that we are all part of something bigger than ourselves. For more information, visit www.bluerocktx.com. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer SOURCE: Bluerock Therapeutics

DUBLIN--( BUSINESS WIRE )--The "Induced Pluripotent Stem Cell (iPSC) Industry Report - Market Size, Trends, and Forecasts, 2024" report has been added to ResearchAndMarkets.com's offering. This global strategic report reveals all major market competitors worldwide, including their core technologies, strategic partnerships, and products under development. It covers the current status of iPSC research, biomedical applications, manufacturing technologies, patents, and funding events, as well as all known trials for the development of iPSC-derived cell therapeutics worldwide. Importantly, it profiles leading market competitors worldwide and presents a comprehensive market size breakdown for iPSCs by Application, Technology, Cell Type, and Geography (North America, Europe, Asia/Pacific, and Rest of World). It also presents total market size figures with projected growth rates through 2030. Since the discovery of induced pluripotent stem cell (iPSC) technology in 2006, significant progress has been made in stem cell biology and regenerative medicine. New pathological mechanisms have been identified and explained, new drugs identified by iPSC screens are in the pipeline, and the first clinical trials employing human iPSC-derived cell types have been initiated. iPSCs can be used to explore the causes of disease onset and progression, create and test new drugs and therapies, and treat previously incurable diseases. Today, methods of commercializing induced pluripotent stem cells (iPSCs) include: Cellular Therapy: iPSCs are being explored in a diverse range of cell therapy applications for the purpose of reversing injury or disease. Disease Modelling: By generating iPSCs from patients with disorders of interest and differentiating them into disease-specific cells, iPSCs can effectively create disease models "in a dish". Drug Development and Discovery: iPSCs have the potential to transform drug discovery by providing physiologically relevant cells for compound identification, target validation, compound screening, and tool discovery. Personalized Medicine: The use of techniques such as CRISPR enable precise, directed creation of knock-outs and knock-ins (including single base changes) in many cell types. Pairing iPSCs with genome editing technologies is adding a new dimension to personalized medicine. Toxicology Testing: iPSCs can be used for toxicology screening, which is the use of iPSCs or their derivatives (tissue-specific cells) to assess the safety of compounds or drugs within living cells. Tissue Engineering: iPSCs can be seeded onto scaffolds made from biocompatible materials. These scaffolds mimic the structure and properties of the target tissue and can provide a supportive environment for cell growth and differentiation. Organoid Production: iPS cells can be coaxed to self-organize into 3D structures called organoids, which mimic the structure and function of organs. Organoids can be used for studying organ development, modeling diseases, and testing drugs. Gene Editing: iPS cells can be genetically modified using techniques like CRISPR-Cas9 to correct disease-causing mutations or introduce specific genetic changes. These edited iPS cells can then be differentiated into the desired cell type for transplantation or disease modeling. Research Tools: iPSCs and iPSC-derived cell types are being widely used within a diverse range of basic and applied research applications. Stem Cell Banking: iPSC repositories provide researchers with the opportunity to investigate a diverse range of conditions using iPSC-derived cell types produced from both healthy and diseased donors. Cultured Meat Production: iPSCs are being utilized in clean meat production by serving as the cellular foundation for the creation of lab-grown meat. 3D Bioprinting: iPSCs can be directed to differentiate into cell types of interest, such as skin, heart, or liver cells, which are then incorporated into bioinks. Wildlife Conservation and De-extinction Projects: iPSCs are being used in wildlife conservation and de-extinction projects. For example, Colossal Biosciences is using iPSC technology in an effort to achieve woolly mammoth de-extinction. Key Topics Covered: 1. REPORT OVERVIEW 2. INTRODUCTION 3. CURRENT STATUS OF IPSC INDUSTRY 3.1 Progress made in Autologous Cell Therapy using iPSCs 3.2 Allogeneic iPSC-based Cell Therapies 3.3 Share of iPSC-based Research within the Overall Stem Cell Industry 3.4 Major Focus Areas of iPSC Companies 3.5 Commercially Available iPSC-derived Cell Types 3.6 Relative use of iPSC-derived Cell Types in Toxicology Testing Assays 3.7 iPSC-derived Cell Types used in Clinical Trials 3.8 Currently Available iPSC Technologies Nucleofector Technology Opti-ox Technology MOGRIFY Technology Transcription Factor-based iPSC Differentiation Technology Flowfect Technology Technology for Mass Production of Platelets SynFire Technology 4. HISTORY OF INDUCED PLURIPOTENT STEM CELLS (IPSCS) 5. RESEARCH PUBLICATIONS ON IPSCS 6. IPSC: PATENT LANDSCAPE ANALYSIS 6.1 iPSC Patent Applications by Jurisdiction 6.2 iPSC Patent Applicants 6.3 Inventors of iPSC Patents 6.4 iPSC Patent Owners 6.5 Legal Status of iPSC Patents 7. IPSC: CLINICAL TRIAL LANDSCAPE 7.1 Number of iPSC Clinical Trials 7.2 Recruitment Status of iPSC Clinical Trials 7.3 iPSC Clinical Trials Study Designs 7.4 Therapeutic & Non-Therapeutic iPSC Clinical Trials 7.5 iPSC-based Trials by Phase of Study 7.6 iPSC Clinical Trials by Funder Type 7.7 Geographic Distribution of iPSC-based Clinical Trials 7.8 Promising iPSC Product Candidates CYP-001, CYP-004 & CYP-006 from Cynata Therapeutics BioVAT-HF from Repairon GmbH HS-001 from Heartseed CNTY-101 from Century Therapeutics FT-576 & FT-819 from Fate Therapeutics RPE from National Eye Institute QN-019a from Qihan Biotech iPSC-CL from Heartworks, Inc. 7.9 Companies having Preclinical iPSC Assets Aspen Neuroscience Ryne Biotech Bluerock Therapeutics Vita Therapeutics Hopstem Biotechnology Res Nova Bio, Inc. Cytovia Therapeutics Hebecell Corporation Sana Biotechnology SCG Cell Therapy Pte Cytomed Shoreline Biosciences Neukio Biotherapeutics Exacis Biotherapeutics CellOrigin Biotech 8. M&A, COLLABORATIONS & FUNDING ACTIVITIES IN IPSC SECTOR 8.1 Mergers and Acquisitions (M&A) Sector Century Therapeutics & Clade Therapeutics Evotech & Rigenerand Fujifilm Corporation & Atara Biotherapeutics Catalent & RheinCell Therapeutics Axol Biosciences & Censo Biotechnologies Bayer AG & Bluerock Therapeutics Pluriomix & Axiogenesis 8.2 Partnership/Collaboration & Licensing Deals in iPSC Sector Shinobi Therapeutics & Panasonic SCG Cell Therapy and A*STAR Charles River Laboratories & Pluristyx, Inc. Pluristyx, Inc. & National Resilience, Inc. University of Texas & GeneCure Heartseed, Inc. & Undisclosed Biotech Bluerock Therapeutics & Bit.bio Applied Stem Cell, Inc. & CIRM Resolution Therapeutics & OmniaBio, Inc. REPROCELL, Inc. & CIRM REPROCELL, Inc. & BioBridge Global Elevate Bio & CIRM Evotec & Sernova Evotec & Almiral Quell Therapeutics & Cellistic MDimmune & YiPSCELL Edigene & Neukio Biotherapeutics Matricelf & Ramot Evotec & Boehringer Ingelheim Pluristyx, Pancella & Implant Therapeutics Century Therapeutics & Bristol Myers Squibb Fujifilm Cellular Dynamics & Pheno Vista Biosciences Metrion Biosciences & Bioqube Ventures Cytovia Therapeutics & Cellectis Exacis Biotherapeutics & CCRM Cynata Therapeutics & Fujifilm Corporation Bone Therapeutics & Implant Therapeutics REPROCELL & TEXCELL Jacobio & Herbecell NeuCyte & KIF1A.ORG Kite & Shoreline Biosciences Neuropath Therapeutics & Hopstem Biotechnology Allele Biotech & Cellatoz Bluerock Therapeutics, Fujifilm Cellular Dynamics & Opsis Therapeutics Newcells & Takeda Biocentriq & Kytopen Fujifilm Cellular Dynamics & Sana Biotechnology Evotec & Medical Center Hamburg-Eppdorf (UKE) NeuCyte & Seaver Autism Center for Research and Treatment Cytovia Therapeutics & National Cancer Institute Mogrify & MRC Laboratory of Molecular Biology 8.3 Venture Capital Funding in iPSC Sector Asgard Therapeutics Kenai Therapeutics Pluristyx Fujifilm Cellular Dynamics Mogrify Ltd. Heartseed, Inc. Elevate Bio Aspen Neurosciences Axol Biosciences Thyas, Co. Ltd Synthego Cellino Biotech, Inc Curi Bio Ncardia Evotec SE bit.bio Clade Therapeutics Shoreline Biosciences Kytopen Cytovia Therapeutics & CytoLynx TreeFrog Therapeutics HebeCell Corporation Neukio Biotherapeutics Stemson Therapeutics Vita Therapeutics Century Therapeutics Heartseed Mogrify Metrion Biosciences Elevate Bio Vita Therapeutics 9. GENERATION OF INDUCED PLURIPOTENT STEM CELLS (IPSCS) 9.1 OSKM Cocktail 9.2 Pluripotency-Associated Transcription Factors and their Functions 9.3 Delivery of Reprogramming Factors 9.3.1 Integrating Systems 9.3.2 Non-Integrative Delivery Systems 9.3.3 Comparison of Delivery Methods 9.4 Genome Editing Technologies in iPSC Generation 9.5 Available iPSC Lines and their applications 10. HUMAN IPSC BANKING 10.1 Major Biobanks Storing iPSCs & iPSC Lines 10.1.1 RIKEN 10.1.2 WiCell 10.1.3 Fujifilm Cellular Dynamics, Inc. 10.1.4 Sampled 10.1.5 Coriell Institute for Medical Research 10.1.6 European Bank for Induced Pluripotent Stem Cells (EBiSC) 10.2 Cell Sources for iPSC Banks 10.3 Reprogramming Methods in iPSC Banks 10.4 Ownership and Investments made in iPSC Banks 11. BIOMEDICAL APPLICATIONS OF IPSCs 11.1 iPSCs in Basic Research 11.2 Applications of iPSCs in Drug Discovery 11.3 Applications of iPSCs in Toxicology Studies 11.4 Applications of iPSCs in Disease Modeling 11.5 Applications of iPSCs in Cell-Based Therapies 11.6 Other Novel Applications of iPSCs 12. MARKET ANALYSIS 12.1 Global Market for iPSCs by Geography 12.2 Global Market for iPSCs by Technology 12.3 Global Market for iPSCs by Biomedical Application 12.4 Global Market for iPSCs by Derived Cell Type 12.5 Market Drivers 12.5.1 Current Drivers Impacting the iPSC Market Place 12.6 Market Restraints 13. COMPANY PROFILES For more information about this report visit https://www.researchandmarkets.com/r/pf57qx About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.