News 2025-01-14
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.
In the future, Porton will continue to adhere to international standards, providing global pharmaceutical companies with one-stop CDMO services for proteins and conjugated drugs, spanning from PCC to IND and GMP clinical supplies.
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.
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News 2025-02-13
Join Porton at Leading Industry Conferences to Explore Innovations and Network with Experts
Porton Pharma Solutions is thrilled to announce its participation in several major industry events across the globe during the first and second quarters of 2025. As a leading end-to-end integrated CDMO company, Porton boasts globally advanced technology platforms and extensive project delivery experience in small molecules, peptides and oligonucleotides, ADCs (including antibodies, payload-linkers, conjugation, and drug product filling), and Advanced Therapy Medicinal Products.
News 2025-01-28
Our Incredible Journey in 2024
Under open skies, the years pass endlessly. As the sun rises, Porton welcomes a new year with sincerity and hope. Reflecting on 2024, we faced challenges together, standing strong and united, achieving great heights.
