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As widely known, Cell and Gene Therapy (CGT) represents one of the most promising and rapidly advancing fields in the current biopharmaceutical landscape, particularly in the treatment of oncological diseases. Cell therapy involves manipulating human cells outside the human body and re-administering them to treat diseases, while gene therapy aims to modify human gene expression or repair abnormal genes through gene addition or editing. CGT therapy stands as the latest frontier in precision medicine, following small molecules, biologics, and targeted therapies, heralding a new wave in the pharmaceutical and therapeutic fields.

From a regulatory standpoint, the Chinese National Medical Products Administration released the " Good Manufacturing Practice of Medical Products - Appendix for Cell Therapy Products (Draft for Solicitation of Opinions)" on January 6, 2022. This regulation applies to the entire process, from the transport and receipt of materials from donors to the production, testing, release, storage, and transportation of cell products. The draft outlines specific requirements for personnel, materials, and quality management at each stage, setting higher and clearer standards to enhance the quality of CGT products.

On the product level, due to the unique characteristics of such products, including high material safety requirement, significant production process variations, small production batches size, high sensitivity to temperature, and the potential for (cross) contamination and errors, it is imperative for CDMO service providers to have a mature system process and experienced professionals for comprehensive management. This assists enterprises in mitigating associated risks and facilitating the smooth and timely completion of clinical trials and other research projects.

As the first professional company in China dedicated to clinical supply chain services, ClinsChain (Shanghai) Clinical Services Co., Ltd. (ClinsChain) understands that the CGT product supply chain represents the final link in ensuring quality assurance. Most CGT products require storage at temperatures below -80°C or even lower and must be delivered in a temperature-controlled manner within a very short timeframe, ensuring the complete traceability of product identity and distribution. Given the complexities and high costs associated with cold chain transportation, particularly in import and export contexts, the best choice for pharmaceutical companies is to find the optimal solution by outsourcing to industry-leading supply chain management experts like ClinsChain.

Currently, ClinsChain has successfully completed quality certification for a storage capacity of 600 liters at -190°C, accommodating at least 15,000 2ml cryogenic tubes. The facility is equipped with a 600-liter automatic liquid nitrogen replenishment system to ensure continuous temperature stability to the required standards.

This investment reaffirms ClinsChain's commitment to customer-centric service, acknowledging and thanking our valued customers for their continuous support and attention.