AmbioPharm manufactures the highest quality peptide products with some of the lowest costs in the industry. We have established relationships with the major raw material manufacturing companies for amino acid derivatives and solvents.
Because of the bulk quantity of raw materials we purchase and our proximity to the source, we can keep costs low without sacrificing quality. In addition, we have implemented solvent recovery systems to further reduce manufacturing costs up to 50% on our large commercial scale, at the same time reducing our solvent waste in an effort to apply sustainable or green chemistry.
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.
AmbioPharm has multiple manufacturing suites capable of producing peptide APIs (Active Pharmaceutical Ingredients) at varying scales from gram to multi-kilogram (>100 kg) scales. We use solid phase synthesis, solution phase synthesis, and hybrid solid/solution phase synthesis to produce peptide APIs.
In addition to producing peptide products at GMP (Good Manufacturing Practice) and GLP (Good Laboratory Practice) standards and requirements, we also provide process development and analytical services for non-GMP/GLP grade peptides. We have added automated peptide synthesizers to help speed our delivery of these non-GMP research peptides. These services are available for a broad range of customers, including Universities, Research Organizations, Biotechnology and Pharmaceutical Companies, and others.
AmbioPharm is one of the world’s largest capacity peptide development and manufacturing companies. With a U.S. headquarters located in North Augusta, South Carolina and facilities in Shanghai, China, we manufacture new chemical entities (NCE) and generic peptides under cGMP for clients worldwide. AmbioPharm also partners with generic drug companies to develop generic peptide drugs for established commercial markets throughout the world.
AmbioPharm has years of experience manufacturing Active Peptide Ingredients (APIs) for peptide vaccines in varying configurations. 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.
As an FDA-inspected, USA-based peptide active pharmaceutical ingredient (API) contract development and manufacturing organization (CDMO), AmbioPharm has the scale and quality systems in place to meet the stringent needs of the cosmetic formulation industry. With experience in all types of peptide synthesis from solid phase to liquid (or solution) phase or a hybrid of strategies, we can synthesize the simplest to most complex cosmetic peptide ingredients, including Argireline.
At the same time as the development process is underway, AmbioPharm will develop analytical HPLC (High Performance Liquid Chromatography) or UPLC (Ultra Performance Liquid Chromatography) methods and validation tools. These tools will monitor the process for side reactions, required purity standards, and limit any residual impurities in the product. Controlling the final API to ensure the required quality attributes, we will minimize process and degradation impurities. This affords formulators the maximum labeled drug shelf life under proper storage conditions.