AmbioPharm, a global peptide CDMO, was founded in 2005 and is headquartered in North Augusta, South Carolina, USA specializing in developing highly efficient manufacturing processes for peptide-based Active Pharmaceutical Ingredients (APIs) at small to very large scales. In our manufacturing facilities in South Carolina, USA and Shanghai, China, we manufacture New Chemical Entities (NCEs) and generic peptide APIs under cGMP for clients worldwide. Both facilities have been inspected multiple times by the FDA with excellent outcomes.
Formed as a subsidiary of AmbioPharm, Inc. in 2011 and spun-out as a standalone company in 2023, Ambio is a drug development company with a rich and growing pipeline of proprietary drug development programs for bioequivalent and biosimilar versions of the world’s best-selling peptide drugs. View the Ambio website here.
AmbioPharm has developed a unique business model designed to handle all types of peptide manufacturing. We can handle any scale project from large to small.
In addition to our years of experience and a stellar reputation in the industry, here are three reasons you should consider AmbioPharm for contract peptide API synthesis:
A peptide CDMO serving pharmaceutical, research, and biotech companies, we can perform solid-phase (SPPS), solution or liquid-phase (LPPS), and/or hybrid peptide chemistry as well as:
Upon request, we can also provide research-grade peptides for pre-clinical in vitro, medicinal efficacy, and toxicology programs. This service provides you with milligrams to multi-grams of research-grade peptides that have been fully qualified and released by our in-house Quality Control team.
In addition to contract peptide manufacturing, we partner with generic drug companies to provide generic peptide APIs for established commercial markets throughout the world.
Our manufacturing facilities have eight process development suites operating in parallel with reactor vessels up to 1,000L (100kg crude peptide/batch) available for solid-phase synthesis and solution reactors up to 5,000L (200kg crude peptide/batch). We maintain scalable HPLC purification systems up to 100cm and multiple lyophilization systems up to 1,000L.
Our two cGMP peptide manufacturing facilities in the US and China can handle any manufacturing scale required and we are regularly enhancing equipment and capacity. We currently operate multiple manufacturing lines capable of sustaining campaigns from grams to >500 kg/year.
For commercial products, we design dedicated facilities at even larger scales to meet current and future needs of our clients. In addition, on-going expansion at our facilities will significantly add to our capacity at all of our sites, to meet the growing needs of our customers and partners.
Our management team has more than two hundred years of cumulative experience in manufacturing and developing Pharmaceutical-grade peptide projects.