20+ Years Expertise
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.
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
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.