GMP Peptide
Neoantigen Peptide Manufacturing
Prompt delivery of neoantigen GMP peptides for immunotherapy applications including
peptide vaccine API drug substances up to phase I clinical trials, ex vivo cell therapy, or for EIND (emergency IND) use. Expeditious turn-around times to meet tight scheduling requirements of multiple, individually manufactured and QC tested peptides.
*Not for individual use; available to approved organizations only.
Privileged Partner for project-based management
We can execute individual peptide manufacturing batches for multiple projects concurrently. Production slot reservations can be organized to optimize delivery schedules.
Key advantages of the service
We are your CMO for custom Neoantigen manufacturing and consistently strive to exceed expectations in quality and service. For nearly 30 years, our customers have leveraged our vast expertise in peptide synthesis and combinatorial chemistry to help achieve their goals.
Timely turn-around
We have the expertise and the technical know-how to manufacture the highest quality of Neoantigen peptides promply.
Technical Expertise
We are pioneers in peptide technology & combinatorial chemistry innovations.
Dedicated Project Manager
We guarantee that you will be kept updated throughout the entire production process.
Traceability
All materials and processes are traceable using batch production records and robust standard operating procedures.
IND Support
IND filling support with complete Chemistry, Manufacturing and Control (CMC) package.
Quality
All Neoantigen peptides are manufactured in our certified ISO 7 classified cleanrooms (10,000) using our stringent QMS.
Your project from start to finish
Your dedicated project manager will be your liaison to guide you from the
initial discussions on CDA and MSA agreements, to manufacturing,
testing and product release.
Customer Discussions
CDA & supplier contracts, product specifications, customer audits.
Feasibility study¹
Small scale production using released raw materials for feasibility.
¹when applicable
Setup
Identification & setting of critical manufacturing parameters.
GMP Manufacturing
Cleanroom manufacturing of the peptides under our QMS using Batch Production Records & SOP’s.
QC Testing & Release
QC release of the product followed by QA review of the manufacturing/testing records, shipping.
Neoantigen vaccines for immunotherapy
Cancer sporadically originates from normal tissues through the accumulation of genetic and epigenetic aberrations.
This genetic instability of cancer cells often leads to the production of abnormal tumor proteins not found in normal cells, called Tumor-Specific Neoantigens (TSNAs), which pose promising opportunities for the development of new vaccines.
Therapeutic cancer vaccines act by inducing tumor degradation, eliminating minimal residual disease, and creating continuous anticancer memory.
