#China #Suzhou #CAR-T therapy #Porton Advanced #Tasly Pharma

Porton Advanced Enhances Tasly's CAR-T Therapy Development

On April 12, 2025, Porton Advanced Solutions made significant strides in the field of cancer treatment by announcing its contract development and manufacturing organization (CDMO) support for Tasly Pharmaceutical Co., Ltd.'s innovative CAR-T therapy, known as P134 Cell Injection. This product targets recurrent glioblastoma (GBM) and has recently received Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA) under Approval No. 2025LP01030.

Insight into Dual-Targeting CAR-T Therapy

Glioblastoma, the most prevalent malignant tumor affecting the central nervous system, presents unique challenges due to its invasive nature, high recurrence rates, and generally poor prognosis. The P134 Cell Injection utilizes a dual-targeting mechanism by focusing on CD44 and CD133, two antigen targets that are distinctly expressed in both primary and recurrent forms of GBM. This specialized recognition and targeting improve T-cell activation and longevity, ultimately enhancing the tumor cell elimination process.

Porton Advanced operates as the exclusive CDMO partner for this pivotal program, and through comprehensive process development and manufacturing services, it ensures high-quality production standards. The collaboration involved crafting plasmids, lentiviral vectors, and the final CAR-T cell products. Impressively, Porton Advanced manufactured multiple clinical-grade product batches for Investigator-Initiated Trials (IITs), achieving quality control success on the first attempt for all batches produced.

Accelerating Advanced Therapy Development

The expertise maintained by the Porton Advanced team in cell therapy development and cGMP production has been instrumental in aiding Tasly Pharma's commitment to delivering innovative oncology treatments globally. Notably, the regulatory submission faced no deficiencies during the CDE review process, further emphasizing the quality and compliance of Porton Advanced’s production systems.

Efficient Production Processes

To enhance efficiency, Porton Advanced utilized a robust two-step chromatography process for plasmid production. This method enabled rapid delivery of engineering runs and GMP batches, allowing for significant time and cost reduction. For output consistency, the team employed their proprietary LV-SMART® lentiviral suspension platform for lentivirus production. This platform not only yielded high consistency but also resulted in a 30% reduction in material costs, optimizing the process by eliminating animal components.

The CAR-T cell production met all required release standards, with over 10 IIT samples produced, reflecting exceptional quality that has facilitated observable clinical efficacy during trials. Through its end-to-end CDMO platform, Porton Advanced has collaborated closely with Tasly, aspiring to provide effective treatment options for patients facing recurrent glioblastoma.

Future Outlook and Company Profiles

Looking ahead, both companies harbor ambitions for the fruitful clinical development of the CAR-T pipeline, aiming to expand treatment options for GBM patients. Porton Advanced is dedicated to strengthening its partnership with Tasly to expedite the delivery of transformative therapies.

About Tasly Pharma

Tasly Pharma, headquartered in Tianjin, China, stands as a prominent modern Chinese medicine enterprise. With over 20 global research centers and 11 production bases, Tasly is committed to evolving into a leading global solution provider for medicine and health services. Emphasizing precision and patient-centric innovative approaches, the company aims to enhance the overall health of individuals by addressing critical therapeutic domains, including cardiovascular, digestion, metabolism, tumor immunity, and neuroscience.

About Porton Advanced

Porton Advanced Solutions, a subsidiary of Porton Pharma Solutions, is based in Cranbury, New Jersey, with GMP facilities located in Suzhou, China. This organization specializes in providing end-to-end CDMO solutions for advanced therapy medicinal products (ATMPs). They cater to a wide range of drug development stages, from initial research phases to clinical trials and eventual commercialization. With advanced facilities spanning 215,000 square feet, Porton Advanced is dedicated to ensuring efficient and high-quality services while maintaining a strong customer-centric focus.

In summary, Porton Advanced's impactful support for Tasly's CAR-T therapy signifies a crucial development in oncology, potentially transforming the treatment landscape for patients suffering from GBM.