GenScript Biotech Corporation, the world's leading provider of life-science research tools and services, has ramped up production of complex and modified peptides at its state-of-the-art cGMP manufacturing facility in Zhenjiang, China. A new, one-stop service offers neoantigen and peptide active pharmaceutical ingredients (API) adapted for large-scale manufacturing. To help drug-development teams shorten their time to market, GenScript also offers expert consulting support for CMC filing documents and the development of global regulatory strategies for new peptide drugs.

"As a leader in peptide synthesis, we recognize the growing market need for fast-track production of cGMP-grade peptides," said Raymond  Miller, associate marketing director at GenScript. "With an increasing number of peptide drugs moving from drug discovery to clinical trials and commercialization, it is critical that we meet the urgent demands of our customers. With over 20 years of experience in peptide synthesis, it is a natural progression for us to enter the cGMP peptide market and support these increasing market demands."

GenScript's cGMP peptide service provides a comprehensive set of services to support GenScript's global biotech customers in their quest to deliver new drugs to market, from preclinical development through clinical trials. It leverages GenScript's extensive manufacturing expertise in the synthesis of complex and modified peptides, including cyclic peptides, peptide-drug conjugates (PDCs), and more.

GenScript's new cGMP facility can deliver up to 48 personalized neoantigen sequences per patient per batch (and up to 500 items per month of sterile product), and supports rapid manufacturing, QC, and release. For peptide APIs, orders of up to 800 g per month (over 20 kg per year) can be delivered. GenScript's in-house scientists provide technical support throughout the drug development process, from drug discovery to CMC.

The new cGMP facility can deliver up to 48 personalized neoantigen sequences per patient per batch, enabling rapid manufacturing, QC, and release. For peptide APIs, orders of up to 800 g per month (over 20 kg per year) can be delivered. GenScript's in-house scientists provide technical support throughout the drug development process, from drug discovery to CMC.

The new Zhenjiang state-of-art cGMP facility has been designed and qualified to meet the GMP requirements of major regulatory authorities such as FDA, EMA, PMDA, and NMPA. GenScript has established a phase-appropriate cGMP system including material system, facilities & equipment system, laboratory control system, production system, packaging and labeling system, all of which are integrated into the quality system. GenScript has also established a sterility assurance program with systematic controls in place to ensure product sterility.

GenScript's cGMP peptide manufacturing facility combines scientific excellence with state-of-the-art technology:

• Meets ICH Q7 guidelines and 21 CFR Part 210/211 regulation guidelines
• Clean suite with Grade A isolator in Grade C background
• Sterile filtration and aseptic fill finish available
• Method development and validation, formal method transfer
• Traceable manufacturing process with master batch record
• CMC compilation

"GenScript's capabilities go way beyond peptide manufacturing — our professional regulatory affairs team provides extensive support in CMC filing documents and the development of global regulatory strategies for peptide new drugs, including drug substances, and drug products. Our team of scientists and technicians is dedicated to helping you succeed," said Hui Feng, director of regulatory affairs at GenScript. "We take on your challenges as if they were our own, and we're committed to delivering high-quality peptides on time, every time."