BioIVT, a global research partner and biospecimen solutions provider for drug and diagnostic development, today announced the launch of VivoSTART™ Cryopreserved GMP Leukopaks. The GMP-compliant leukopaks ensure the quality, safety, and traceability of cellular starting material to support cell and gene therapy (CGT) platform process development and clinical trials.

BioIVT是药物和诊断开发的全球研究合作伙伴和生物样本解决方案提供商，今天宣布推出VivoSTART™冷冻保存的GMP白细胞包。这些符合GMP标准的白细胞包确保了细胞起始材料的质量、安全性和可追溯性，以支持细胞和基因治疗（CGT）平台的工艺开发和临床试验。

The addition to the company’s portfolio of human derived cellular starting materials emphasizes the commitment to supporting cell therapy development..

公司新增的人源细胞起始材料进一步彰显了其对支持细胞治疗开发的承诺。

The Impact on Cell Therapy Innovation

细胞治疗创新的影响

With over 35 years of experience in biospecimen procurement to bring the best products to researchers in need – including its diverse donor pool consisting of over 600 recallable consented donors in the U.S. and U.K. – BioIVT continues to unlock the potential for its clients. With the global cell and gene therapy market exploding with a projection of $97 billion by 2033, the new offering is intended to enable smarter science and accelerate medical breakthroughs for researchers..

拥有超过35年的生物样本采购经验，为有需要的研究人员提供最佳产品——包括其多样化的捐赠者群体，其中包含美国和英国超过600名可召回的已同意捐赠者——BioIVT持续为客户释放潜力。随着全球细胞和基因治疗市场激增，预计到2033年将达到970亿美元，这项新服务旨在推动更智能的科学研究，并加速研究人员的医学突破。

“BioIVT is proud to continue innovating by delivering trusted, reproducible, and reliable experimental results to our partners through consistent cell populations. Taking into account clients who require GMP-compliant cellular starting materials but may lack the capacity or resources to integrate fresh leukopaks into their development timelines, cryopreserved leukopaks offer the flexibility to allocate and schedule resources for downstream processing of leukapheresis material—ensuring client needs are met through our growing portfolio,' said Dr.

“BioIVT很荣幸能够通过提供一致性细胞群体，持续为我们的合作伙伴提供值得信赖、可重复和可靠的实验结果。考虑到那些需要符合GMP规范的细胞起始材料但可能缺乏能力或资源将新鲜白细胞包整合到其开发时间表中的客户，冷冻保存的白细胞包为下游处理白细胞分离材料提供了灵活的资源分配和调度选择——确保通过我们不断扩展的产品组合满足客户需求，”博士说道。

Parijat Jain, Vice President, Cell & Gene Therapy at BioIVT. “With comprehensive documentation—including detailed donor information, processing records, and quality control data—our partners can move forward with confidence in their decisions and the next step of their cell therapy journey.”.

BioIVT细胞与基因治疗副总裁Parijat Jain表示：“通过全面的文档记录——包括详细的捐赠者信息、处理记录以及质量控制数据——我们的合作伙伴可以对其决策和细胞治疗旅程的下一步充满信心。”

Building on the company’s unmatched portfolio, the VivoSTART Cryopreserved Leukopak is a distinct format within the VivoSTART category of BioIVT’s GMP-compliant products and current leukopak offerings, including last year’s introduction of LEUKOMAX XL. Combining high-quality starting cellular material, substantial target cell counts, and cryopreservation with regulatory oversight enables the progress of advanced therapies from development through manufacturing..

基于公司无与伦比的产品组合，VivoSTART冷冻保存的Leukopak是BioIVT公司GMP合规产品和当前Leukopak系列产品中VivoSTART类别的独特形式，其中包括去年推出的LEUKOMAX XL。结合高质量的起始细胞材料、大量的目标细胞计数以及在监管监督下的冷冻保存技术，可推动先进疗法从开发到生产的进展。

With enhanced regulatory oversight following cGMP guidelines, clients pursuing clinical phase development and downstream commercialization can feel confident in meeting their current and future market needs. Specifically, researchers have unmatched flexibility with the ability to process the leukopaks according to experimental timelines and resource availability, while also improving efficiency and reducing variability by receiving multiple leukopaks from the same donor and processing them in batches.

随着遵循cGMP指南的监管力度增强，追求临床阶段开发及下游商业化的客户可以满怀信心地满足当前和未来的市场需求。具体而言，研究人员在根据实验时间表和资源可用性处理白细胞包（leukopaks）时拥有无与伦比的灵活性，同时通过接收来自同一捐赠者的多个白细胞包并进行批次处理，提高了效率并减少了变异性。

For researchers facilitating collaboration across different research sites, the offering provides standardized and stable starting material that can be shipped and processed independently..

对于促进不同研究地点之间合作的研究人员而言，该产品提供了可以独立运输和处理的标准化且稳定的起始材料。

If you’re interested in learning more or exploring all of BioIVT’s leukopaks offerings, please visit www.bioivt.com.

如果您有兴趣了解更多或探索BioIVT的所有白细胞包产品，请访问www.bioivt.com。

About BioIVT

关于BioIVT

BioIVT enables smarter science and accelerates medical breakthroughs by delivering high-quality personalized biospecimen solutions and research services to the life science and diagnostic industries. We specialize in control and disease state samples including human and animal tissues or preparations, ADME products and research services, cell and gene therapy products, blood, and other biofluids.

BioIVT通过为生命科学和诊断行业提供高质量的个性化生物样本解决方案和研究服务，助力更智能的科学研究并加速医学突破。我们专注于对照和疾病状态样本，包括人体和动物组织或制备物、ADME产品及研究服务、细胞和基因治疗产品、血液及其他生物液体。

Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE®.

我们无与伦比的临床样本组合直接支持精准医学研究，并通过将全面的临床数据与捐赠者样本相结合，努力改善患者预后。通过整合我们的技术专长、卓越的客户服务以及对生物样本的无与伦比的获取能力，BioIVT作为值得信赖的合作伙伴，服务于研究社区，致力于推动科学发展®。