Overview

With over 20 years of experience in custom peptide services, GenScript specializes in providing neoantigen peptides for personalized therapies, complex modified peptides such as innovative cyclic peptides, peptide conjugates, and other modified peptides for drug discovery customers worldwide.

Our new cGMP compliant manufacturing facility enables us to provide reliable one-stop services from peptide drug development, IND filing to clinical trials. Our professional regulatory affairs team also provides extensive support in CMC filing documents and the development of global regulatory strategies for peptide new drugs. We understand that every project is unique, and our team of experts work closely with our customers to deliver tailored solutions that meet their specific needs.

20+ Years Expertise

20+ Years Expertise

  • Support throughout the drug development process, from drug discovery to CMC
  • Expertise in complex and modified peptides, such as cyclic peptides, peptide-drug conjugates (PDCs), etc.
  • Delivers up to 48 personalized neoantigen sequences/patient/batch, enabling rapid manufacturing, QC, and release.
cGMP Compliance

cGMP Compliance

  • Meets ICH Q7 and 21 CFR 210/211 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
  • CMC compilation & master batch record
Regulatory support

Regulatory support

  • Regulatory strategy for peptide drug substance or drug product
  • Support for regulatory authority interactions, including pre-IND or scientific advice meetings
  • IND and CTA support and responses to regulatory questions
Production Facility
Production Facility

cGMP manufacturing opened 2023

One-stop service, provide drug development to regulatory compliance for IND application

Clean suite with Grade A isolator in Grade C background

Sterile filtration and aseptic fill finish for neoantigen

Process development and scale-up competence

Delivers up to 48 personalized neoantigen sequences/patient/batch, enabling rapid manufacturing, QC, and release.

Complex sequences and peptide modifications adapted to large scale production, including cyclic peptides and peptide-drug conjugates.

QA/QC & Documentation
QA/QC & Documentation

TSE/BSE Statement

Traceable and comprehensive batch production records

Identity, purity, bioburden, endotoxin, etc., clearly defined for raw materials

Material supplier management

Validated QC testing procedures

Long-term stability test under various solutions and storage conditions

Phase-appropriate GMP implemented and documented

Support from Discovery to Clinical Trials

GenScript offers the manufacturing expertise, capacity, and validated platform processes to accelerate your neoantigen and API peptide from early drug discovery to the clinic Phase I/II study. Our complete suite of phase-appropriate cGMP facilities and one-stop service provide the flexibility to support your project at all stages.

Support from Discovery to Clinical Trials

Get in Touch
with GenScript cGMP Peptide Synthesis

Get in Touch with GenScript Custom Peptide Services
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