Our team at AmbioPharm has manufactured APIs for peptide vaccines in all sorts of configurations for many groups over many years. Our experience includes naked antigenic sequences of varying lengths, single antigens, Multi-Antigenic-Peptides (MAPS), peptide conjugations to KLH, and multiple peptide vaccine cocktails. All these drug substances have their particular manufacturing challenges, but making the peptide construct, even under cGMP conditions, is relatively easy for us. However, the downstream challenges that can add significant value to your project are analytical, formulation, and regulatory.
Analytical: FDA will require a high degree of certainty regarding analytical purity and identity of each drug substance (each peptide), related substances (truncated, deletion, de-amidated sequences) and residuals such as solvents, water and counter-ion. The degree of challenge rises exponentially with the number of peptides in the drug cocktail. Ambiopharm’s team has experience developing, optimizing, and validating analytical systems for complex peptide vaccines.
Formulation: The formulation of the drug product in sterile dose vials may well be the determining factor in in-vivoefficacy. Excipients, adjuvants and bulking agents must be selected and combined. Final form in frozen aliquot or lyophilate must be stored under cGMP-appropriate conditions. Selection of the 3rd party Contract Manufacturing Organization (CMO) for sterile dose vials is critical. We can assist with these interactions and have worked with many fill & finishing organizations on behalf of our clients.
Regulatory: SOPs, Documentation, and AmbioPharm’s history with FDA will be important to the value of your IP after collecting human data. We have been audited by over 30 companies, large-pharmas and smaller biotechs, consultants, etc. and we have products in every phase of development from pre-clinical to commercialization. We can assist in filing INDs and are prepared to file a DMF at the appropriate future opportunity.