Successful GMP Drug Product Delivery by Porton Biologics and Conjugates Platform

Recently, the Porton Biologics and Conjugates Platform successfully completed the GMP contract manufacturing of three batches of sterile drug products for a client at our R&D and production facility in Pudong, Shanghai. This milestone marks a significant step forward for our Biologics and Conjugates CDMO platform—a testament to our unwavering commitment to quality and reliability.

The special process requirement and tight timeline brought quite a challenge at beginning. Thanks to Porton's advanced design of drug product manufacturing line, the light protection solution, nitrogen-purged filling, and minimal-loss filling modules make it possible to achieve client’s needs on product quality. After undergoing rigorous and repeated trials and testings, Porton’s R&D and production team successfully launched the project and completed the project from aseptic process simulation, gap analysis, new product introduction assessment, material procurement, risk assessment, tech transfer, IPC method qualification to GMP production and product release within just two months.

Porton's drug product manufacturing line is equipped to offer flexible and adaptable GMP manufacturing solutions, accommodating the diverse process requirements of various client projects. The achievement of this milestone project was made possible by the well-established quality system at Porton's Shanghai Pudong site, along with the exceptional project management capabilities of the Porton team. Porton’s project team kept close communication with the client and showed strong execution during the project period. Porton won the client’s trust, satisfaction and appreciation for their professional performance.

About Porton Biologics and Conjugates CDMO Platform

Porton Biologics and Conjugates CDMO Platform operates multiple R&D centers and GMP manufacturing sites in Shanghai, China, and New Jersey, USA respectively. It provides integrated, end-to-end CDMO solutions for global pharmaceutical companies and drug development institutions, covering all stages from preclinical development to commercial launch for biologics and conjugates. The platform offers a comprehensive range of services, including Payload-Linker preparation, conjugate drug developability research, cell line construction, upstream and downstream process development, conjugation process development, formulation development, analytical method development, GMP manufacturing of drug substance (DS) and drug product (DP) for biologics and conjugates, stability studies, clinical trial material production, and CMC services such as pharmaceutical documentation support for regulatory filings.