药明生基发布TESSA™技术，进一步扩大细胞和基因疗法的生产规模，显著提高创新疗法的可及性 | Bilingual News

▎药明康德

-TESSA™技术为基因疗法提供可规模化的生产工艺，加速生产大量治疗性DNA载体

-《Nature Communications》最新数据指出：利用TESSA™载体生产的腺相关病毒（AAV）是基于质粒方法生产的10倍，新的产能可以支持10倍患者数量的治疗

美国费城，2022年3月8日–药明康德旗下专注于细胞和基因疗法的CTDMO药明生基今日正式发布TESSA™技术。这是一种符合药品生产质量管理规范（GMP）的先进生产工艺，用于规模化生产无转染的腺相关病毒（AAV）。该技术由药明生基全资英国子公司OXGENE自主研发，通过大幅提升AAV的生产规模，降低细胞和基因疗法的生产成本，助力客户推动更多突破性疗法早日问世，造福全球病患。

AAV载体通常应用于血友病和阿尔茨海默症等疾病的基因疗法。随着行业需求的不断增长，高效的AAV规模化生产工艺变得至关重要。而TESSA™载体能够有效应对这一挑战，对提升患者接受先进疗法的可及性具有重大意义。

近日《Nature Communications》发布的最新数据也支持了TESSA™技术的优势。数据指出，在相同的生产体积中，利用TESSA™载体生产的AAV是基于质粒方法生产的10倍，这意味着新的产能可以支持10倍患者数量的治疗。

“TESSA™系统不仅改变了AAV的生产方式，还推动了细胞和基因疗法发展，以更好地造福患者。”药明生基首席科学官Ryan Cawood博士表示，“通过提高基因疗法的产能，降低工艺复杂性和生产成本，TESSA™将更好地赋能我们的合作伙伴，让更多创新疗法惠及全球患者。”

作为一个全球化运营的细胞和基因疗法CTDMO，药明生基独特的商业模式将强大的测试能力与工艺开发及生产平台能力紧密结合，如用于AAV生产的TESSA™技术和用于慢病毒稳定生产的Lenti解决方案等。通过药明生基的一体化赋能平台，所有的检测开发、生物安全、病毒清除和最终产品放行检测等环节都能在这个平台上得以实现，帮助客户大幅缩短先进疗法的上市周期。

关于药明生基

药明生基是药明康德旗下专注于细胞和基因疗法的CTDMO，致力于加速和变革细胞和基因疗法及其他高端疗法的开发、测试、生产和商业化。药明生基能够助力全球客户将更多创新疗法早日推向市场，造福病患。更多信息，请访问www.wuxiatu.com。

关于药明康德

药明康德（股票代码：603259.SH/2359.HK）为全球生物医药行业提供一体化、端到端的新药研发和生产服务，在亚洲、欧洲、北美等地均设有运营基地。药明康德通过独创的“CRDMO”和“CTDMO”业务模式，不断降低研发门槛，助力客户提升研发效率，为患者带来更多突破性的治疗方案，服务范围涵盖化学药研发和生产、生物学研究、临床前测试和临床试验研发、细胞及基因疗法研发、测试和生产等领域。2021年，药明康德被MSCI评为ESG（环境、社会及管治）AA级。目前，公司的赋能平台正承载着来自全球30多个国家的5700多家合作伙伴的研发创新项目，致力于将更多新药、好药带给全球病患，早日实现“让天下没有难做的药，难治的病”的愿景。更多信息，请访问公司网站：www.wuxiapptec.com

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WuXi ATU Announces Launch of TESSA™ Technology to Improve Scalability and Accessibility of Cell and Gene Therapies

-TESSA™ technology provides a scalable process for manufacturing gene therapies, accelerating the production of large quantities of therapeutic DNA required to treat patients in need

-New data published in Nature Communications supports the benefits of this technology

March 7, 2022 – Philadelphia. WuXi Advanced Therapies (WuXi ATU), a wholly owned subsidiary of WuXi AppTec, today announced the launch of Tetracycline-Enabled Self-Silencing Adenovirus (TESSA™). This technology is a state-of-the-art novel process for transfection-free, scalable manufacture of adeno-associated virus (AAV) at Good Manufacturing Practice (GMP) grade. Developed by OXGENE in the United Kingdom, a WuXi Advanced Therapies company, TESSA™ will expedite AAV manufacturing and significantly reduce the cost for manufacturing cell and gene therapies, enabling global customers to deliver more accessible ground-breaking therapeutics to patients as quickly as possible.

AAV vector is a popular tool for the delivery of gene therapies in diseases such as haemophilia and Alzheimer’s. Efficient processes for manufacturing AAV on a large scale are critical to meeting increasing industry demands. TESSA™ vectors can meet the scalability challenges of AAV production, which has significant implications for expanding patient access to these novel therapeutics.

The new data published in Nature Communications supports the benefits of this technology. It highlights that in the same manufacturing volume, TESSA™ vectors produced 10 times more AAV than plasmid-based manufacture, producing enough material to treat ten times the number of patients. 

“The TESSA™ system is a game changer for the manufacture of AAV and the advancement of cell and gene therapies to benefit patients.” said Dr. Ryan Cawood, Chief Scientific Officer of WuXi ATU. “By improving scalability, reducing process complexity and lowering the costs of gene therapy manufacture, TESSA™ will better enable our global partners to develop and deliver life-saving gene therapies faster to more patients in need.”

As a Contract Testing Development and Manufacturing Organization (CTDMO) with operations globally, WuXi ATU’s unique business model integrates powerful testing capabilities with its advanced therapies’ process development and manufacturing platforms, such as TESSA™ technology for AAV manufacturing and Lenti stable solutions for lentiviral manufacturing. This allows all assay development, biosafety, viral clearance and product release testing to be completed in-house, shortening customers’ timelines for the approval of advanced therapies.

About WuXi Advanced Therapies (WuXi ATU)

As the advanced therapies business unit of WuXi AppTec, WuXi Advanced Therapies is a Contract Testing, Development and Manufacturing Organization (CTDMO) that offers integrated platforms to transform the discovery, development, testing, manufacturing, and commercialization of cell and gene therapies. Our services and solutions accelerate time to market and support customer programs around the world. For more information, please visit https://www.advancedtherapies.com 

About WuXi AppTec

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable global pharmaceutical and healthcare industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, cell and gene therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received AA ESG rating from MSCI in 2021 and its open-access platform is enabling more than 5,700 collaborators from over 30 countries to improve the health of those in need – and to realize the vision that "every drug can be made and every disease can be treated."

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