细胞治疗制造服务
我们亲自参与的细胞治疗制造服务专长涵盖各种自体和异体细胞类型和起始材料，包括但不限于：
- 免疫细胞群（即 T 细胞、NK、树突状细胞等）
- 干细胞（即 MSC、HSC 等）
- 其他需要的细胞类型
此外，我们拥有处理 TIL、肿瘤（切除/活检/裂解物）、单采材料（包括动员血、全血和白膜层）的经验。
我们提供三种车间配置以满足可扩展需求：
- 经验证的 ISO 7 B 级生产容器车间符合美国 FDA 标准，可用于细胞疗法生产或病毒转导
- 经验证的 ISO 7 B 级生产车间符合美国 FDA 和欧盟 GMP 附录 1 的细胞培养要求
- 经验证的 ISO 7 B 级生产车间符合美国 FDA 和欧盟 GMP 附录 1 的细胞培养或病毒转导要求
为什么要与我们合作进行细胞治疗制造？
我们的团队精通各种可用于细胞治疗制造过程的技术平台。我们多年的经验使我们能够为您提供我们的最佳实践和规模放大的见解，不仅提高安全性，而且还为患者和整个行业降低产品成本。我们的能力包括：
- 制造科学与技术 (MSAT) 团队
- 质量管理体系（从商业化的早期阶段）
- 质量控制/放行检测
- 监管支持
- 临床阶段运营和物流
- 技术操作
- 检测方法开发
- 验证和确认
- 工艺开发实验室
作为值得信赖的细胞治疗 CDMO，我们可以管理您的产品开发生命周期和相关供应链的各个方面。我们管理供应链整合、与多方（如单采中心和诊所）的调度、温度和/或在与不同供应商发货之前、期间和之后的受控存储。我们还代表您与其他 CMO 和/或监管机构进行全球临床试验和/或产品推广，以及与患者收集机构和客户 CRO 联络。
正在为您即将推出的细胞治疗制造计划寻求支持？
-
Manufacturing Science and Technology (MSAT) team
A team comprised of experts in process development, technology transfer, and manufacturing support, offers optimized and scalable cell therapy manufacturing processes to bolster high-quality, efficient, and cost-effective manufacturing.
-
Quality management systems (QMS)
From early phase through commercial manufacturing our comprehensive QMS ensure therapies are safe, effective, and meet regulatory compliance standards.
-
Quality control/release testing
We uphold the safety, purity, and potency of cell therapy products through comprehensive analytical testing, meeting regulatory compliance, and maintaining quality throughout development and manufacturing.
-
Regulatory support
This team will help you navigate the complex landscape of cell therapy development, ensuring compliance with global regulations at every stage to commercial manufacturing.
-
Clinical operations and logistics
Having access to shipping and distribution of patient materials and therapies as well as regulatory compliance guidance and project management expertise for clinical trials is paramount. Seamlessly progress treatments through clinical development into commercial manufacturing.
-
Assay development
We offer assay development services to support cell therapy product characterization and release testing. Develop and validate assays to facilitate the safety, purity, and potency of cell therapies with the help of our specialists.
-
Validation and qualification
Our team of experts can support developing and executing validation and qualification plans, including process and equipment, facility, and software validation.
Are you looking for support for cell therapy CDMO support for your upcoming program?
Cell Therapy Supply Chain Solutions for Minimizing Vein-to-Vein Time
We understand the intricate nature of cell therapy supply chain management within the manufacturing process. As part of our comprehensive services, we specialize in managing supply chain integration to ensure a seamless flow of materials and information throughout the development of cell therapy manufacturing, and commercial production process.
Supply Chain Management
We excel in coordinating schedules and collaborations with apheresis centers and clinics to facilitate the timely and safe collection of patient samples, including the harvest, formulation, packaging, and cryopreservation of cells and cell therapies.
Temperature-Controlled Storage & Shipment
We prioritize cell therapy integrity by meticulously managing temperature-controlled storage and transportation requirements before, during, and after shipping to preserve quality and efficacy. This includes customs clearance.
Logistics and Distribution
Our logistical solutions include the final stage of thawing and administering the therapy to maximize therapeutic benefits. Located near the FedEx Super Hub, our Memphis facility minimizes transit times and ensures timely delivery of critical materials.
Regulatory Bodies and Facilitating Clinical Trials
We take pride in our role as a trusted partner in your cell therapy manufacturing process. We not only support relationships with regulatory bodies and act as your advocate, we interface with additional Contract Manufacturing Organizations (CMOs) and regulatory agencies for global clinical trials and product roll-outs. We understand the importance of seamless coordination and liaise with patient collection facilities and your Contract Research Organizations (CROs). With our expertise and extensive network in cell therapy CDMO services, we are here to ensure that your manufacturing runs smoothly and efficiently, from Phase 1 to commercialization, allowing you to focus on advancing your therapies and bringing your products to market.
Frequently Asked Questions (FAQs) About Cell Therapy Manufacturing
-
What are the steps in the cell therapy manufacturing process?
- Starting Material Acquisition: Donor cells (allogeneic therapy) or patient cells (autologous therapy) are collected and processed to obtain the initial cell population.
- Cell Isolation and Expansion: The desired cell population is isolated and expanded in culture to achieve sufficient cells for therapy.
- Genetic Modification (if applicable): Gene editing or transduction techniques may be employed to introduce therapeutic genes or modify cell characteristics.
- Cell Harvesting: The cells are harvested from the culture and processed to remove impurities and unwanted cell components.
- Formulation and Final Product Preparation: The cells are formulated into the final product, which may involve cryopreservation, formulation in a specific medium, or other processing steps.
- Quality Control Testing: The final product undergoes extensive testing to meet safety, identity, potency, and purity requirements.
- Release and Distribution: Once the final product passes quality control testing, it is released for clinical use. It is then distributed to the treatment site or patient.
Throughout the cell therapy manufacturing process, regulatory compliance, quality management, and documentation are crucial in ensuring the cell therapy product's safety, efficacy, and traceability.