GenScript Launches New and Comprehensive Service

New Comprehensive Service from GenScript GenScript Biotech Corporation, a leading provider of life sciences research tools and services worldwide, has expanded complex and modified peptide production at its state-of-the-art cGMP manufacturing facility in Zhenjiang, China. The new single-source service offers neoantigen and peptide active pharmaceutical ingredients (APIs) adapted for large-scale production. To help pharmaceutical development teams reduce time to market, GenScript also provides expert consulting support for CMC filing documentation and development of global regulatory strategies for new peptide drugs. Raymond Miller, Associate Marketing Director at GenScript, said, "As a leading firm in peptide synthesis, we are aware of the growing market need for rapid production of cGMP-grade peptides." "With the increasing number of peptide drugs progressing from drug discovery to clinical trials and commercialization, it is critical that we meet our customers' urgent demands. With over 20 years of experience in peptide synthesis, entering the cGMP peptide market and supporting these growing market demands is a natural progression for us." GenScript's cGMP peptide service offers a comprehensive suite of services to support GenScript's global biotech customers from preclinical development through clinical trials as they pursue bringing new drugs to market. This service leverages GenScript's comprehensive 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 batch per patient (and up to 500 sterile products per month) and supports rapid production, quality control and market launch. Peptide APIs can be ordered at up to 800 g per month (over 20 kg per year). GenScript's in-house scientists provide technical support throughout the drug development process from drug discovery through CMC. The new cGMP facility can deliver up to 48 personalized neoantigen sequences per batch per patient and provides rapid production, quality control and market launch capabilities. Peptide APIs can be ordered at up to 800 g per month (over 20 kg per year). GenScript's in-house scientists provide technical support throughout the drug development process from drug discovery through CMC. The new state-of-the-art cGMP facility in Zhenjiang has been designed and qualified to meet GMP requirements of major regulatory bodies such as the FDA, EMA, PMDA and NMPA. GenScript has established a phase-appropriate cGMP system including material systems, facility and equipment systems, laboratory control systems, production systems, packaging and labeling systems, all of which are integrated into the quality system. GenScript has also established a sterility assurance program with systematic controls implemented to ensure product sterility.

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

- Complies with ICH Q7 guidelines and 21 CFR Part 210/211 regulatory guidelines - Class A isolator with Class C background clean suite - Sterile filtration and aseptic fill coating available - Method development and validation, formal method transfer - Traceable production process with master batch records - CMC compilation Hui Feng, Director of Regulatory Affairs at GenScript, said "GenScript's capabilities extend far beyond peptide production—our professional regulatory affairs team provides comprehensive support in CMC filing documentation and development of global regulatory strategies for new peptide drugs, including drug substances and drug products. Our team of scientists and technicians is committed to helping you succeed," he added, "We take on the challenges you face as if they were our own and are determined to deliver high-quality peptides on time, every time."   Source