Industry Leadership: Shanghai Cellular Therapy Group Collaborates with China Association for Pharmaceutical Quality Management to Launch Visible Particulate Matter Standards for Cell Therapy Products

Recently, to address the confusion in visible particle inspection during the production process of injectable and ophthalmic solution manufacturers, and to meet the requirements of the Chinese Pharmacopoeia and GMP Annex 1,The kick-off meeting for the topic of visible particles in cell therapy products, hosted by Shanghai Cell Therapy Group Co., Ltd., a co-creation partner of Haier Capital, was held in the academic lecture hall of Shanghai Cell Therapy Group.This launch event for the research project was hosted by the China Pharmaceutical Quality Management Association, with the aim of further establishing industry standards for visible particulate judgment.

Visible Particulates as a Safety Criterion for the Release Testing of Cell Therapy Products: Currently, the industry commonly faces challenges in controlling the production process and lacks a practical and unified standard for release testing. Establishing scientific and rigorous industry standards is not only crucial for the healthy development of the industry but also vital for the health and safety of every patient.

Haier Capital's co-creation partner in the healthcare field — Shanghai Cell Therapy Group, with over a decade of experience in cell therapy, has proactively undertaken and promoted the launch of industry standards for visible particulates in cell therapy products.In order to reach a consensus on the industry's visible particulate group standard, address practical pain points, and contribute to the healthy development of the cell therapy industry.

At the launch meeting, Zhao Guiying, standing vice president of the China Pharmaceutical Quality Management Association, delivered a speech emphasizing the association's attention to the visible particulate matter group standard. Liu Yanlu, secretary-general of the China Pharmaceutical Quality Management Association, presented the opening report of the seminar. Subsequently, Bi Jun, chief expert of the Shenzhen Market Supervision Administration Licensing Review Center, delivered a keynote report titled "EU GMP Annex 1: Manufacture of Sterile Medicinal Products," introducing the revision process, main features, and key contents of previous standard establishment projects.

The launch meeting proceeded smoothly, establishing a task force on visible particles in cell therapy products. Preliminary discussions identified the sources, control measures, testing methods, acceptance criteria, and release strategies for visible particles in cell therapy products, forming a draft standard. The China Pharmaceutical Quality Management Association also expressed its intention to establish a platform, organize offline meetings, and provide enterprises with opportunities for visits, exchanges, and learning to facilitate the rapid establishment of the standard.

As one of the most important co-creation partners in the medical and health field of Haier Capital, Shanghai Cell will also continue to leverage the ecological resources of the group's healthcare industry to provide comprehensive resource connection and collaborative support for Shanghai Cell. Both parties will work together to build a win-win healthcare industry ecosystem. Meanwhile, based on the practice of full ecological investment and co-creation model, they will continue to extensively connect innovative forces, enhance the influence of ecological brands, collaborate with more high-quality co-creation partners, and focus on promoting industrial innovation and development.