GenScript Biotech Corporation, a global leader in life-science research tools and services, has significantly increased the production of intricate and modified peptides at its cutting-edge cGMP manufacturing facility in Zhenjiang, China.
A newly introduced comprehensive service now offers neoantigens and peptide active pharmaceutical ingredients (APIs) tailored for large-scale manufacturing. To expedite drug development timelines, GenScript also provides expert advisory assistance for CMC filing documentation and the formulation of global regulatory strategies for novel peptide medications.
Raymond Miller, Associate Marketing Director at GenScript, emphasized the growing market demand for expedited production of cGMP-grade peptides. As a leader in peptide synthesis for over two decades, GenScript is well-positioned to respond to the urgent needs of its customers as more peptide drugs transition from discovery to clinical trials and commercialization.
The cGMP peptide service from GenScript encompasses a comprehensive range of offerings aimed at supporting global biotech clients in their journey from preclinical development to clinical trials and beyond. Leveraging their extensive manufacturing proficiency in complex and modified peptide synthesis, including cyclic peptides and peptide-drug conjugates (PDCs), GenScript is poised to enter the cGMP peptide market and address the growing industry requirements.
The newly established cGMP facility in Zhenjiang has been meticulously designed and qualified to meet the GMP standards of prominent regulatory bodies such as the FDA, EMA, PMDA, and NMPA.
GenScript's phase-appropriate cGMP system includes various components like material systems, facilities and equipment systems, laboratory control systems, production systems, and packaging and labeling systems – all seamlessly integrated into the quality framework. The facility also boasts a comprehensive sterility assurance program to ensure product sterility.
GenScript's state-of-the-art cGMP peptide manufacturing facility combines advanced technology with scientific excellence:
- Adheres to ICH Q7 guidelines and 21 CFR Part 210/211 regulations
- Features a clean suite with Grade A isolator within a Grade C background
- Offers sterile filtration and aseptic fill finish capabilities
- Provides method development and validation, along with formal method transfer
- Implements a traceable manufacturing process with master batch record
- Encompasses CMC compilation
Hui Feng, Director of Regulatory Affairs at GenScript, highlighted the company's comprehensive capabilities beyond peptide manufacturing, specifically mentioning the robust support offered by their professional regulatory affairs team.
This support includes guiding clients through CMC filing documentation and devising global regulatory strategies for new peptide drugs, both in terms of drug substances and drug products. The dedication of GenScript's scientists and technicians to ensuring timely and high-quality peptide production is emphasized, with a commitment to tackling challenges and delivering exceptional results.
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