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MINNEAPOLIS--(BUSINESS WIRE)--NMDP BioTherapies℠, formerly Be The Match BioTherapies, a leader in cell and gene therapy development support, unveiled substantial upgrades to its cellular starting material offerings, including incorporating a Drug Master File (DMF) with its rapid-delivery, standard GMP leukopak to simplify regulatory filings.
明尼阿波利斯--(商业新闻短讯)--NMDP生物疗法℠, 以前是Match BioTherapies,细胞和基因治疗开发支持的领导者,公布了其细胞起始材料产品的实质性升级,包括将药物主文件(DMF)与其快速递送,标准GMP leukopak合并以简化监管文件。
The strategic enhancements to its suite are designed to address the evolving needs of the allogeneic cell therapy industry, emphasizing optimized delivery times, customizable options, and expanded capabilities..
其套件的战略增强旨在满足异基因细胞治疗行业不断发展的需求,强调优化的交付时间,可定制的选项和扩展的功能。。
“We have leveraged over three decades of experience in managing cellular product collections, working closely with cell and gene therapy developers to deliver an advanced allogeneic suite of compliant products,” said Tom Hochuli, President of NMDP BioTherapies. “These investments in our cellular starting material offerings are a testament to our commitment to advancing the cell and gene therapy industry.
NMDP BioTherapies总裁汤姆·霍丘利(TomHochuli)表示:“我们在管理细胞产品系列方面拥有30多年的经验,与细胞和基因治疗开发人员密切合作,提供先进的异基因兼容产品套件。”。“这些对我们细胞起始材料产品的投资证明了我们致力于推进细胞和基因治疗行业。
We are building products and services to meet the short and long-term needs of developers and continue to strive to supply industry-leading support and flexibility for allogeneic cell therapy development.”.
我们正在构建产品和服务,以满足开发人员的短期和长期需求,并继续努力为同种异体细胞疗法开发提供业界领先的支持和灵活性。”。
NMDP BioTherapies supports organizations that are creating next-generation cell and gene therapies. With access to donors and cord blood units from the NMDP Registry℠, which is the world’s most diverse registry, and an extensive collection network, NMDP BioTherapies provides a wide variety of cell sourcing options for developers of allogeneic cell and gene therapies so that they can expand treatment options for patients with life-threatening or debilitating diseases..
NMDP生物疗法支持正在创建下一代细胞和基因疗法的组织。可以从NMDP登记处获得捐赠者和脐带血单位℠, NMDP BioTherapies是世界上最多样化的注册中心和广泛的收集网络,为同种异体细胞和基因疗法的开发人员提供了多种细胞来源选择,以便他们可以为威胁生命或使人衰弱的疾病患者扩展治疗选择。。
“Along with our Cord Blood Bank Alliance members, we are addressing an important unmet need: identification of additional cord characteristics required to qualify units for manufacture of cell and gene therapies,” added Hochuli.
“与我们的脐带血库联盟成员一起,我们正在解决一个尚未满足的重要需求:确定额外的脐带特征,以使生产细胞和基因疗法的单位合格,”霍丘利补充道。
The updated product and service suite includes the clinical-grade leukopak , research use only (RUO) leukopak and cord blood units (CBUs), each tailored to support developers from early discovery through to commercialization. The suite includes:
更新的产品和服务套件包括临床级leukopak,仅研究用途(RUO)leukopak和脐带血单位(CBU),每一个都是为了支持开发人员从早期发现到商业化而定制的。该套件包括:
Optimized Standardized GMP Leukopak for Rapid Delivery with Optional Modular Customizations. NMDP BioTherapies has refined its standard GMP leukopak to offer a fresh, clinical-grade product that can be delivered quickly, complete with a DMF on file to facilitate regulatory processes. Developers can also benefit from modular customizations such as specific donor demographics, cryopreservation and international compliance, ensuring a match with their precise needs..
优化的标准化GMP Leukopak可通过可选的模块化定制快速交付。NMDP BioTherapies完善了其标准GMP leukopak,提供了一种新鲜的临床级产品,可以快速交付,并有DMF存档,以促进监管过程。开发人员还可以从模块化定制中受益,例如特定的捐赠者人口统计数据、冷冻保存和国际合规性,从而确保与他们的确切需求相匹配。。
Expanded RUO Leukopak for Versatile Research Applications. Recognizing the diverse stages of cell therapy development, NMDP BioTherapies has broadened its RUO leukopak capabilities. This expansion supports developers from initial phases, when specific donor characteristics might be unclear, to later stages when strict adherence to clinical requirements is a necessity..
扩展的RUO-Leukopak可用于多种研究应用。认识到细胞疗法发展的不同阶段,NMDP生物疗法扩大了其RUO-leukopak的能力。这种扩展支持开发人员从最初阶段(具体的捐赠者特征可能不清楚)到后期(必须严格遵守临床要求)。。
Enhanced CBU Offering for Allogeneic Cell Therapy. The Cord Blood Bank Alliance has also evolved its CBU offering, focusing on expanding testing capabilities for key characteristics, such as KIR and CD16. This advancement enables a more detailed analysis of the cord blood bank inventory, crucial for identifying units with characteristics vital for manufacturing allogeneic cell therapies.
为同种异体细胞治疗提供增强的CBU。脐带血库联盟还改进了其CBU产品,重点是扩展关键特征(如KIR和CD16)的测试能力。这一进步使得能够对脐带血库库存进行更详细的分析,这对于识别具有制造同种异体细胞疗法至关重要的特征的单元至关重要。
Partnering with NMDP BioTherapies provides access to a team of experienced regulatory and cell collection experts who have gained their expertise over 35+ years of managing global deliveries of cellular products for clinical and commercial use..
与NMDP BioTherapies合作,可以接触到一支经验丰富的监管和细胞收集专家团队,这些专家在35多年的时间里积累了管理全球临床和商业细胞产品交付的专业知识。。
About NMDP BioTherapies
关于NMDP生物疗法
NMDP BioTherapies is the only cell and gene therapy solutions provider with customizable services to support the end-to-end cell therapy supply chain. Backed by NMDP’s industry-leading experience and a research partnership with the CIBMTR® (Center for International Blood and Marrow Transplant Research®), the organization designs solutions that advance the development of cell and gene therapies worldwide..
NMDP BioTherapies是唯一一家提供可定制服务以支持端到端细胞治疗供应链的细胞和基因治疗解决方案提供商。该组织凭借NMDP业界领先的经验以及与CIBMTR®(国际血液和骨髓移植研究中心®)的研究合作伙伴关系,设计了推动全球细胞和基因疗法发展的解决方案。。
NMDP BioTherapies is dedicated to accelerating patient access to life-saving cell and gene therapies by providing high-quality cellular source material from the NMDP Registry, the world’s most diverse registry of more than 7 million potential blood stem cell donors. Through established relationships with apheresis, marrow collection and transplant centers worldwide, the organization develops, onboards, trains and manages expansive collection networks to advance cell therapies.
NMDP BioTherapies致力于通过从NMDP登记处提供高质量的细胞源材料,加速患者获得挽救生命的细胞和基因疗法,NMDP登记处是世界上最多样化的登记处,拥有700多万潜在的造血干细胞捐献者。通过与世界各地的单采、骨髓采集和移植中心建立关系,该组织开发、组建、培训和管理广泛的采集网络,以推进细胞疗法。
NMDP BioTherapies uses a proven infrastructure consisting of regulatory compliance and managed logistics experts and cell therapy supply chain case managers to successfully transport and deliver regulatory-compliant life-saving therapies across the globe. Through the CIBMTR, NMDP extends services beyond the cell therapy supply chain to include long-term follow-up tracking for FDA-approved CAR-T therapies..
NMDP BioTherapies使用由法规遵从性和管理物流专家以及细胞治疗供应链案例管理人员组成的经验证的基础设施,在全球范围内成功运输和提供符合法规的救生疗法。通过CIBMTR,NMDP将服务扩展到细胞疗法供应链之外,包括对FDA批准的CAR-T疗法进行长期跟踪。