Porton Advanced Solutions, a specialized contract development and manufacturing organization (CDMO) for advanced therapy medicinal products (ATMPs), has announced significant progress in its cell therapy partnerships, including regulatory approval for a novel CAR-T therapy and a new collaboration to advance solid tumor treatments.
Tasly's Dual-Targeting CAR-T Therapy Receives IND Approval
On April 12, 2025, Porton Advanced announced that its CDMO support has helped Tasly Pharmaceutical secure Investigational New Drug (IND) approval from China's National Medical Products Administration (NMPA) for "P134 Cell Injection," an innovative dual-targeting CAR-T therapy for recurrent glioblastoma (GBM).
As the exclusive CDMO partner for this program, Porton Advanced provided comprehensive services spanning plasmid production, lentiviral vectors, and final CAR-T cell products. The company successfully manufactured dozens of batches of clinical-grade investigational products for Investigator-Initiated Trials (IITs), with all batches passing quality control on the first attempt.
The regulatory submission achieved zero deficiencies during the Center for Drug Evaluation (CDE) review, highlighting the robustness of Porton's quality systems and production stability.
GBM, the most common primary malignant tumor of the central nervous system, is characterized by high invasiveness, frequent recurrence, and poor prognosis. Tasly's P134 Cell Injection is an autologous CAR-T product targeting CD44 and/or CD133, antigens that are highly and mutually exclusively expressed in primary and recurrent GBM. The therapy's mechanism involves specifically recognizing and binding to these targets, effectively activating and prolonging T-cell lifespan to eliminate tumor cells.
New Partnership with Hualong Biological for MATC Therapy
In a separate development announced on May 19, 2025, Porton Advanced has formed a partnership with Hualong Biological to accelerate the development of Multi-Activated T Cell (MATC) therapy for solid tumors.
Under this collaboration, Porton Advanced will provide end-to-end CDMO services for Hualong's MATC therapy, from process optimization to regulatory submission. Hualong's research team has already established a strong clinical foundation for its MATC platform through multiple investigator-initiated trials, demonstrating significant therapeutic benefits across various solid tumor indications.
Mingguang Huang, Chairman of Hualong Biological, commented on the partnership: "Their comprehensive CDMO technical expertise and regulatory experience in cell therapy will significantly enhance our MATC program's development efficiency and IND preparation timeline. Together, we're committed to advancing this innovative therapy into clinical trials to benefit patients worldwide."
Porton's Advanced Cell Therapy Manufacturing Capabilities
Porton Advanced has developed specialized platforms for various components of cell therapy manufacturing, each offering distinct advantages:
For plasmid production, the company employs a robust two-step chromatography process that enables rapid delivery of engineering run and GMP batches, significantly shortening timelines and reducing costs.
Their lentiviral production utilizes the proprietary LV-SMART® lentiviral suspension platform, achieving high batch-to-batch consistency, high yield, high infectious titers, and low residual impurities, while reducing material costs by 30% with animal component-free processes.
In CAR-T production, Porton Advanced has demonstrated the ability to produce high-transfection-efficiency CAR-T cells meeting all release standards, delivering over 10 IIT samples with consistent quality, contributing to observable clinical efficacy in IIT studies.
Expanding ATMP Manufacturing Infrastructure
Porton Advanced operates state-of-the-art, GMP-compliant facilities spanning 215,000 square feet, equipped with 10 viral vector production lines and 12 GMP-compliant cell therapy production suites, including two suites for infectious donors.
The company has successfully supported clients in securing 18 global IND approvals from regulatory authorities including the NMPA, FDA, and Medsafe, with five ongoing Phase I/II ATMP projects. Additionally, Porton Advanced has facilitated the successful transition of several overseas clinical-stage pipelines into China.
Andrew Chen, CFO of Porton Advanced, emphasized the company's commitment: "Porton Advanced is committed to supporting partners through our integrated technology platform and regulatory experience to bring cutting-edge therapies to patients faster."
With headquarters in Cranbury, New Jersey, and two GMP sites in Suzhou, China, Porton Advanced continues to expand its global footprint in the rapidly growing cell and gene therapy sector, offering services from cell banking and process development to cGMP production and fill & finish operations.
