Approval enables regulated analysis services for cell and gene therapies. This important milestone for TATAA Biocenter provides customers access to safety testing, accelerating the transition of promising therapies from laboratory research and preclinical testing to clinical applications.

批准可以为细胞和基因疗法提供受监管的分析服务。TATAA Biocenter的这一重要里程碑为客户提供了安全测试的机会，加速了有前途的疗法从实验室研究和临床前测试向临床应用的转变。

GOTHENBURG, Sweden, April 16, 2024 /PRNewswire/ -- TATAA Biocenter announced today that it has been awarded Good Laboratory Practice (GLP) accreditation. The accreditation represents a crucial step in the company's strategic progression into a market leading molecular analysis contract research organization (CRO) expediting biopharmaceutical innovations in advanced therapies and precision medicine..

瑞典哥德堡，2024年4月16日/PRNewswire/--塔塔生物中心今天宣布，它已获得良好实验室规范（GLP）认证。该认证代表了该公司向市场领先的分子分析合同研究组织（CRO）战略发展的关键一步，该组织加速了先进疗法和精准医学的生物制药创新。。

The demand for these services is driven by the over 2500 cell and gene therapies being developed in the United States and Europe and the progress of technologies involving CRISPR, AAV vectors, and mRNA therapeutics. These innovations require rigorous molecular analyses and adherence to regulated guidelines for bioanalysis and safety testing, including biodistribution, pharmacokinetics, transgene expression, and shedding throughout the developmental stages of therapies..

对这些服务的需求是由美国和欧洲正在开发的2500多种细胞和基因疗法以及涉及CRISPR，AAV载体和mRNA疗法的技术进步所驱动的。这些创新需要进行严格的分子分析，并遵守生物分析和安全性测试的规范指南，包括生物分布，药代动力学，转基因表达和整个治疗发展阶段的脱落。。

With the addition of GLP accreditation to its existing Good Clinical Laboratory (GCLP) compliant work and ISO/IEC 17025 accreditation, TATAA Biocenter is now positioned to support clients through all development stages and regulatory filings. TATAA operates from a laboratory purpose-built around reliable, contamination-free PCR workflows, offering clients method development, qualification, and validation..

随着GLP认证加入到其现有的良好临床实验室（GCLP）合规工作和ISO/IEC 17025认证中，塔塔生物中心现在可以在所有开发阶段和监管备案中为客户提供支持。TATAA以可靠、无污染的PCR工作流程为基础，建立了专门的实验室，为客户提供方法开发、鉴定和验证。。

With GLP-accredited quantitative PCR and digital PCR services, TATAA Biocenter facilitates reliable safety and efficacy assessments for emerging cell and gene therapy regulatory applications. The accreditation follows an additional investment from Care Equity, which was completed in the fall of 2023 to further empower TATAA Biocenter in its continued growth and long-term ambitions..

凭借GLP认可的定量PCR和数字PCR服务，TATAA Biocenter为新兴细胞和基因治疗监管应用提供了可靠的安全性和有效性评估。该认证是在Care Equity的额外投资之后进行的，该投资于2023年秋季完成，以进一步增强塔塔生物中心的持续增长和长期雄心。。

'As one of few laboratories with GLP accreditation for qPCR and dPCR, we can now support the pharmaceutical industry in a comprehensive way and accelerate the process through even more robust analyses, allowing therapies to reach the patient faster, ' said Mathias Hallin, CEO of TATAA Biocenter.

塔塔生物中心（TATAA Biocenter）首席执行官马蒂亚斯·哈林（Mathias Hallin）说：“作为少数几个获得qPCR和dPCR GLP认证的实验室之一，我们现在可以全面支持制药行业，并通过更强大的分析加速这一过程，使治疗更快地到达患者。”。

For more information, visit www.tataa.com or contact Johanna Nilsson, Head of Marketing (johanna.nilsson@tataa.com)

欲了解更多信息，请访问www.tataa.com或联系营销主管JohannaNilsson(johanna.nilsson@tataa.com)（笑声）

About TATAA Biocenter

关于塔塔生物中心

TATAA Biocenter specializes in providing regulated molecular analysis laboratory services for biopharmaceutical clients. Committed to quality, innovation, and fostering strong client relationships, we serve as your trusted partner to accelerate drug development. As a contract research organization, we offer clients the latest technologies and generate accurate and reproducible data that shortens time-to-market.    .

塔塔生物中心专门为生物制药客户提供受监管的分子分析实验室服务。致力于质量、创新和培养强大的客户关系，我们是您值得信赖的合作伙伴，以加速药物开发。作为一家合同研究机构，我们为客户提供最新技术，并生成准确且可重复的数据，从而缩短上市时间。。

TATAA's core focus is delivering high-quality, high-throughput bioanalysis for cell and gene therapies and biomarker profiling for precision medicine. Integral to the success of every study with TATAA Biocenter is the team of highly skilled scientists with extensive experience in nucleic acid analyses and knowledge of regulatory requirements..

TATAA的核心重点是为细胞和基因疗法提供高质量，高通量的生物分析，并为精准医学提供生物标志物分析。塔塔生物中心每项研究的成功都离不开一支拥有丰富核酸分析经验和监管要求知识的高技能科学家团队。。

This information was brought to you by Cision http://news.cision.com

此信息由Cision提供给您http://news.cision.com

https://news.cision.com/tataa-biocenter/r/tataa-biocenter-achieves-glp-accreditation-for-qpcr-and-dpcr,c3962284

https://news.cision.com/tataa-biocenter/r/tataa-biocenter-achieves-glp-accreditation-for-qpcr-and-dpcr，c3962284

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/21227/3962284/2735251.pdf

https://mb.cision.com/Main/21227/3962284/2735251.pdf

TATAA Biocenter GLP Press release EN (1)

TATAA Biocenter GLP新闻稿EN（1）

https://news.cision.com/tataa-biocenter/i/press-release-photo-1,c3289561

https://news.cision.com/tataa-biocenter/i/press-release-photo-1，c3289561

Press release photo 1

新闻稿照片1

https://news.cision.com/tataa-biocenter/i/press-release-4,c3289562

https://news.cision.com/tataa-biocenter/i/press-release-4，c3289562

Press release 4

新闻稿4