AmbioPharm has more than a decade of experience manufacturing Active Peptide Ingredients (APIs) for peptide vaccines in varying compositions.
Our experience in high-quality manufacturing allows us to make the peptide construct within cGMP standards and provide both quality and value. We also provide guidance on expertise in three key areas that are critical to successful implementation: analytical, formulation, and regulatory.
The FDA requires 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 challenge rises exponentially with the number of peptides in each drug cocktail. AmbioPharm’s team has extensive experience developing, optimizing, and validating analytical systems for complex peptide vaccines.
The formulation of the drug product in sterile dose vials may well be the determining factor in in-vivo efficacy. Excipients, adjuvants and bulking agents must be selected and combined. Final form in frozen aliquot or lyophilizate 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.
SOPs, Documentation, and AmbioPharm’s history with the FDA will be important to the value of your IP after collecting human data. We have been audited by over 30 companies, large Pharma companies, smaller Bio-Techs, and consultants. Likewise, we are routinely audited by FDA inspectors at both sites. We have products in every phase of development from pre-clinical to commercialization.
We can assist in filing INDs (Investigational New Drug Applications), and we are prepared to file a DMF (Drug Master File) at the appropriate time.