Latest news with #GMP-grade
Korea Herald
07-05-2025
- Business
- Korea Herald
Minaris Advanced Therapies launches as the leading global partner dedicated to cell therapy development, manufacturing, and testing
New company unveiled at the annual ISCT conference in New Orleans combines two tenured and innovative CDMOs with a testing powerhouse PHILADELPHIA, May 7, 2025 /PRNewswire/ -- Through strategic acquisitions made by New York–based investment firm Altaris, Minaris Regenerative Medicine and the U.S. and U.K. operations of WuXi Advanced Therapies have been combined to form Minaris Advanced Therapies ™, a global cell therapy CDMO and testing partner. The company is headquartered in Philadelphia, Pennsylvania. With modern facilities approved for commercial production in the United States (Allendale, NJ and Philadelphia), Europe (Munich) and Asia-Pacific (Yokohama, Japan), Minaris Advanced Therapies manufactures clinical-stage and commercial products on three continents and has a proven track record of delivering more than 7,500 GMP batches. The company currently manufactures two commercial cell therapies and provides testing services for more than 27 commercial products. The company's capabilities include innovative platforms, development and manufacturing capabilities for cell therapies and viral vectors, and extensive testing services. With more than 25 years of cell therapy CDMO experience and over 40 years of experience in biosafety testing and product characterization, the new company will support the next wave of commercial cell therapies. "CDMOs supporting the cell therapy industry have struggled to evolve from a small-scale cottage industry to deliver cost effective manufacturing at scale," said Iain Baird, chairman of Minaris Advanced Therapies. "Our mission is to solve the development and manufacturing challenges preventing these promising therapies from successful worldwide commercialization." The team includes more than 1,400 industry professionals with deep scientific and regulatory expertise. The company's testing business unit provides unrivalled expertise in analytical method development and GMP-grade biosafety and product characterization testing services for both in-house and external programs. "Minaris Advanced Therapies is designed to help the industry treat more patients by providing the experience, global footprint, and platforms to accelerate timelines and enable commercialization," said Eytan Abraham, Ph.D., chief commercial and technology officer. "Many of the technologies needed to reduce cost of goods sold and improve turnaround time already exist, we will drive their adoption and implementation at scale." Built for speed, scale and science Minaris Advanced Therapies brings together: About Minaris Advanced Therapies Minaris Advanced Therapies is a global contract development and manufacturing organization (CDMO) and contract testing provider focused exclusively on cell and gene therapies. Minaris Advanced Therapies is headquartered in Philadelphia, Pennsylvania, and has more than 730,000 square feet of infrastructure across the United States, Europe and Asia. We have manufactured and released over 7,500 GMP batches and our global network supports therapy developers through early-stage development, clinical trials and commercial manufacturing. By combining scientific expertise with best-in-class manufacturing and testing services, we help bring safe, effective therapies to patients faster and more efficiently. Visit to learn more.
Associated Press
30-04-2025
- Business
- Associated Press
PL BioScience Launches World's Only Patented Gamma-irradiated Human Platelet Lysate
AACHEN, Germany, April 30, 2025 (GLOBE NEWSWIRE) -- PL BioScience GmbH, a German life science company specializing in the production and development of Human Platelet Lysate (HPL) for cell expansion, today announced the launch of ELAREM™ Ultimate-FD PLUS, the only gamma-irradiated, GMP-grade Human Platelet Lysate produced in Germany using a globally patented process. With the increasing demand for safe, xeno-free, ethically sourced cell culture supplements in cell therapy, regenerative medicine, and biopharmaceutical manufacturing, ELAREM™ Ultimate-FD PLUS answers a critical industry need: a virus-inactivated, animal-free, and EU-manufactured alternative that meets the highest quality standards. 'We are thrilled to bring the only gamma-irradiated Human Platelet Lysate produced in Europe to the dynamic field of cell and gene therapy,' said Dr. Hatim Hemeda, Chief Executive Officer of PL BioScience. 'This product isn't just a milestone for Europe – it's a globally unique offering. With comprehensive patent protection and fully EU-based production, ELAREM™ Ultimate-FD PLUS ensures a stable supply chain and offers global manufacturers a high-quality, regulatory-ready solution that meets the highest international standards.' Cell culture supplements are essential for growing cells in the laboratory. They play a critical role in the development and manufacturing of advanced therapies like cell and gene therapies. Traditionally, these supplements often contain components derived from other species, such as fetal bovine serum (FBS). These animal-derived products carry potential safety risks, for example bacterial or viral contamination, and pose ethical concerns. HPL offers a fully human-derived, xeno-free alternative that is safe, consistent, and sustainable. ELAREM™ Ultimate-FD PLUS takes this one step further. Through a proprietary gamma-irradiation process, the product undergoes viral inactivation to add an extra layer of safety and regulatory assurance. The gamma-irradiated, xeno-free, fibrinogen-depleted, and anticoagulant-free product complies with the relevant GMP (Good Manufacturing Practice) guidelines. This makes it especially suitable for cell manufacturing applications where viral reduction is critical, such as potential use in clinical trials. About Human Platelet Lysate: Human Platelet Lysate (HPL) is an innovative, human-derived cell culture supplement used to support the growth and expansion of cells in research and clinical development, particularly in cell therapy, stem cell, and regenerative medicine applications. It is produced from donated human blood platelets that are no longer suitable for transfusion and would otherwise be discarded – making it a sustainable and resource-efficient alternative to traditional cell culture supplements. In cell culture, HPL provides essential growth factors and nutrients that promote healthy, robust cell proliferation. Compared to conventional products such as Fetal Bovine Serum (FBS), which is harvested from unborn calves, HPL delivers more consistent results in cell growth, is free from animal-derived pathogens, and aligns with the increasing demand for animal-free and ethically responsible laboratory practices. ELAREM™, PL BioScience's line of xeno-free HPL products, can be used from early-stage research to the production of cell-based therapies under Good Manufacturing Practice (GMP) conditions for the treatment of patients. About PL BioScience: Located in Aachen in Germany, PL BioScience GmbH is a life science company specializing in the production and development of Human Platelet Lysate (HPL), offering a complete portfolio of HPL products tailored for various use cases. From academic and preclinical research to cell therapy and biopharmaceutical manufacturing, ELAREM™ ensures seamless translations of regenerative medicine breakthroughs – from the lab to patients in need. With ELAREM™ Ultimate-FD PLUS, PL BioScience produces the only globally patented gamma-irradiated HPL product. For more information on PL BioScience and the ELAREM™ product offerings, visit: Contact: Dr. Hatim Hemeda, CEO PL BioScience GmbH +49(0)24195719-100 [email protected] Media contact: MC Services AG Raimund Gabriel, Dr. Regina Lutz +49 (0)89 210 228 0 US: Catherine Featherston +1-203-444-4393 E-Mail: [email protected]
Associated Press
09-04-2025
- Business
- Associated Press
ProBio Sets New Standard in GMP Plasmid DNA Manufacturing with Guaranteed ≥ 85% Supercoiled DNA, Fixed-Cost, Clinical-Grade Delivered in Just 3 Months
Hopewell-based team delivers on ProBio's promise of speed, quality, and reliability—offering a transparent, fixed-cost model and ≥85% supercoiled plasmid DNA in record time for clinical programs. HOPEWELL, N.J., April 9, 2025 /PRNewswire/ -- ProBio, a global contract development and manufacturing organization (CDMO), is pleased to announce the launch of its GMP Plasmid DNA manufacturing service at its state-of-the-art facility in Hopewell. This new service guarantees the delivery of clinical-grade plasmid DNA production from cell bank to batch release in just three months. This is a significantly faster manufacturing time than is typical and can help accelerate the development of gene and cell therapies. 'At ProBio, our mission is to redefine reliability and innovation for biopharma partners' said Allen Guo, CEO of ProBio . 'We understand pharmaceutical companies' concerns about how many plasmid DNA manufacturers do not have predictable timelines and we are committed to raising the bar for the industry and we will deliver at the speed drug developers deserve. Our commitment is to provide therapy developers with the confidence and consistency needed to advance their breakthroughs.' Key Advantages of Hopewell's Plasmid DNA Services: Faster Timelines to Clinic: ProBio delivers GMP-like plasmids as little as 4 weeks and GMP-grade plasmids as fast as 3 months, reducing time to clinic accelerating development timelines. Guaranteed Delivery (On-Time, On-Spec): ProBio guarantees that each plasmid, whether in small batches (50–200 mg) or gram-level production, meets developers' exact specifications. With full transparency and no hidden costs, ProBio provides consistent, accurate deliveries on time and on-spec. Consistently High Quality: Leveraging reliable U.S.-based sourcing, advanced single-use technologies, and rigorous quality controls, ProBio provides a dependable solution that reduces contamination risks while ensuring consistent, high-quality plasmid DNA with greater than or equal to 85% supercoiled plasmid DNA content. Ben Chen, Chief Quality Officer at ProBio , added: 'Our approach to quality is deliberate and built into every step of our operations. We've implemented industry best practices and phase-specific quality controls, including in-house testing, stability studies, environmental monitoring, and customizable quality packages – whether standardized or customized. Backed by comprehensive documentation systems and regulatory alignment, this ensures we deliver high-quality plasmid DNA our clients can trust—on time and on spec.' The Hopewell facility, which has a rich legacy of biologics innovation, previously served as a research hub for a leading global pharmaceutical company and later as an AAV-based gene therapy manufacturing center. Now the centerpiece of ProBio's operations, the site is led by a team of industry veterans with decades of experience in biologics and cell and gene therapies. By combining this expertise with ProBio's proprietary platform technologies, the company ensures fast, high-quality, and consistently reliable integrated end-to-end capabilities—from plasmid DNA production to drug product fill and finish. Strategically located to serve both the U.S. and European markets, the Hopewell facility offers a seamless, fully integrated approach to manufacturing. ProBio's expertise in process development, in-house analytical testing, method development, and project management team, minimizes the need for multiple suppliers, significantly accelerating development timelines. Michael Vreeland, Site Head at the Hopewell facility , emphasized the company's commitment to efficiency: 'By bringing both plasmid DNA and eventually, viral vector manufacturing under one roof, we eliminate unnecessary delays and simplify the manufacturing process for our clients. Every operation at ProBio is carefully designed to address the challenges therapy developers face, ensuring smooth progress toward their goals.' ProBio's cGMP Plasmid DNA manufacturing service represents a significantly advancement in the biopharma sector, delivering faster, more reliable, and higher-quality therapeutic development. ProBio's cGMP AAV manufacturing capabilities are expected to launch by Q3 2025, followed by cGMP LVV capabilities in Q1 2026, further expanding the company's integrated service offerings. ABOUT PROBIO ProBio is a global leader in advancing the development and manufacturing of next generation biologics and advanced therapies for the biotech and pharmaceutical industries. As a fully integrated end-to-end Contract Development and Manufacturing Organization (CDMO), ProBio partners with its clients to optimize drug development, accelerate time-to-market, and provide comprehensive life-cycle support. Through a collaborative, risk-sharing approach, ProBio offers flexible licensing and co-development options for new therapeutics, enabling partners to effectively navigate the complexities of human disease with adaptable, cutting-edge therapeutic approaches. Press Contact:
