Porton Advanced Backs IND-Approved P134 CAR-T Therapy with CDMO Services

• Porton Advanced has been named the exclusive CDMO partner for Tasly Pharmaceutical’s IND-approved CAR-T therapy, P134 Cell Injection, for recurrent glioblastoma.

• The company delivered full process development and manufacturing services, including plasmid, lentiviral vectors, and CAR-T products, with all clinical-grade batches passing QC on the first attempt.

Porton Advanced has been appointed the exclusive contract development and manufacturing organisation (CDMO) for Tasly Pharmaceutical Co., Ltd’s dual-targeting CAR-T therapy, P134 Cell Injection. The therapy recently received Investigational New Drug (IND) approval from China’s National Medical Products Administration (Approval No.: 2025LP01030) and is intended for the treatment of recurrent glioblastoma (GBM).

The CDMO provided end-to-end support for the programme, including the development and manufacture of plasmid DNA, lentiviral vectors, and final CAR-T cell products. According to the company, dozens of batches of clinical-grade investigational materials were delivered for investigator-initiated trials (IITs), with each batch passing quality control on the first attempt.

Tasly’s P134 Cell Injection is an autologous CAR-T therapy targeting CD44 and/or CD133 antigens. These targets are reportedly highly and mutually exclusively expressed in both primary and recurrent GBM tumours. The therapy is designed to activate and prolong the lifespan of T-cells for tumour cell elimination.

Porton Advanced utilised several proprietary manufacturing platforms for the project. Its LV-SMART lentiviral system was used to achieve high yields and consistency while reducing impurities and materials cost. Its plasmid production employed a two-step chromatography process to accelerate delivery timelines.

The regulatory submission to China’s CDE achieved zero deficiencies, highlighting the robustness of Porton Advanced’s quality system. The CDMO expressed its intention to continue supporting Tasly’s CAR-T development as the therapy progresses through clinical stages.