GMP Manufacturing

The GMP manufacturing professionals at AmbioPharm have more than 200 years of cumulative experience in peptide process development, scale up, and cGMP (Current Good Manufacturing Practice standards, as defined by the FDA). We can manufacture peptides using solution phase (liquid phase or LPPS), solid phase peptide synthesis (SPPS), or hybrid processes.

Our teams have developed, scaled up, and manufactured up to 300kg of GMP peptide APIs by the solid phase process and up to 50kg of peptide APIs by convergent solid and solution phase synthesis processes. We also develop and manufacture peptide conjugations to proteins (such as KLH (Key Hole Limpet Hemocyanin)), toxoids, antifungals, and PEG (Polyethyleneglycol), under cGMP.

Whether you need a peptide for early research, a new chemical entity (NCE) starting clinical trials or commercial production, or analytical development and validation services, we would be happy to be your partner. Contact us to learn more or to request a quotation.

The AmbioPharm Advantage

AmbioPharm can manufacture the highest quality peptides with some of the lowest costs in the industry. We have established relationships with the major raw material manufacturing companies for amino acid derivatives, resins and solvents and are able to pass these savings onto to our clients.

Because of the large amounts of raw materials that we purchase, we are able to keep costs lower than many of our competitors. In addition, we have solvent recovery systems to further reduce manufacturing costs on large scale.

With fully-controlled cGMP systems, rigorous systems, and experienced management, we can provide the most reasonable cost of manufacturing with either solution phase or solid phase peptide synthesis to our partners.

Solution Phase Process vs Solid Phase Process

Comparison of solution phase peptide synthesis (or liquid phase peptide synthesis) vs solid phase peptide synthesis (SPPS)

See also our FAQ, “How are Peptides Synthesized”?

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