GMP– tag –
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REPROCELL Pioneers Integrated iPSC Manufacturing Platform, Accelerating US Phase III Clinical Programs with AI-Enhanced Gene Editing and GMP Compliance
REPROCELL Japan Overview REPROCELL has launched a comprehensive iPSC manufacturing platform designed to accelerate the clinical development of iPSC-derived therapeutics, notably supporting a US Phase III program. The platform integrates ... -
NurExone Accelerates U.S. Market Entry with GMP Exosome Manufacturing Partnership with Made Scientific, Targeting First Batch by H1 2027
BioPharma BoardRoom USA Overview Exo-Top Inc., a U.S. subsidiary of NurExone Biologic Inc., has signed an MOU with Made Scientific, Inc. for a GMP exosome manufacturing partnership in the U.S. This strategic alliance aims to accelerate N... -
Cellistic CTO Highlights Japanese Conditional Approvals for Cardiac and Parkinson’s iPSC Products, Outlining Path to Commercial-Scale iPSC Cell Therapy Manufacturing
The Medicine Maker UK Overview In an interview with The Medicine Maker, Stefan Braam, CTO of Cellistic, stated that the industry's main focus is the ability to consistently provide iPSC-based cell therapies at commercial scale for large ... -
Next-Generation Bioinks Create New Opportunities in Tissue Engineering and Drug Discovery via 3D Bioprinting
ACS Publications USA Overview Advances in next-generation bioinks are significantly propelling the fields of tissue engineering and regenerative medicine through 3D bioprinting technology. These bioinks are essential for creating microen... -
Extracellular Vesicles Emerge as Promising Biomarkers and Therapeutics for Cardiovascular Disease
Exosome-RNA.com USA Overview Researchers at Massachusetts General Hospital have highlighted the significant potential of extracellular vesicles (EVs) as both diagnostic biomarkers and therapeutic agents for cardiovascular diseases (CVD).... -
Merck Expands Singapore BioReliance Lab with Asia Pacific’s First Cell Line Characterization and GMP NGS Capabilities
BioPharma APAC Singapore Overview Merck is expanding its Singapore BioReliance lab to strengthen analytical and biosafety testing services in the Asia Pacific region. The expanded facility will offer the first BioReliance Cell Line Chara... -
Rapid Rise of iPSC-Based Therapies: Manufacturing Challenges and FUJIFILM Cellular Dynamics’ Automation Solutions
Contract Pharma International Overview iPSC-based therapies are rapidly advancing as a renewable, standardized source for allogeneic treatments and scalable solutions across various indications. However, manufacturing poses challenges in... -
Capricor Therapeutics Establishes Commercial Manufacturing for Deramiocel Cell Therapy for DMD, Reports Q2 2026 Financials
Capricor Therapeutics USA Overview Capricor Therapeutics reported its Q2 2026 financial results, highlighting commercial and manufacturing readiness for its lead product candidate, Deramiocel. This allogeneic cardiac-derived cell therapy... -
Porton Advanced Secures China NMPA Drug License to Expand CDMO Services to Commercial CGT Manufacturing
Porton Advanced China Overview Porton Advanced has been granted a Class C Drug Manufacturing License by China's NMPA, enabling it to undertake commercial contract manufacturing for Cell and Gene Therapy (CGT) products. This expands their... -
NueCell Bio Launches 26,300-Square-Foot Cell Therapy Development Facility to Scale CDMO Services in San Diego
PharmaSource USA Overview NueCell Bio has launched as a dedicated cell therapy science and development services company, opening a 26,300-square-foot facility in San Diego to support translational development, process development, analyt...
