AmbioPharm provides our customers with a full range of services to produce GMP peptides and APIs (Active Pharmaceutical Ingredients) at varying scales from gram to multi-kilogram scale.
Depending upon the project, we use solid phase peptide synthesis (SPPS), solution phase synthesis (or liquid phase), and hybrid solid/solution phase synthesis to produce peptide APIs.
From preclinical to commercial, AmbioPharm has multiple manufacturing suites capable of handling nearly any project scale. AmbioPharm’s unique business model is designed to handle efficient and swift peptide manufacturing. We can produce the highest-quality products of any scale at a lower price than most competitors.
We provide synthesis, process development and analytical services for non-GMP grade peptides. These services are available for a broad range of customers, including Universities, Research Organizations, Biotech Companies, Big Pharma, and others. Included in our non-GMP production is a CEM Liberty Blue microwave peptide synthesizer which helps us to meet faster time-frame deliveries.
We produce peptide products at GMP (Good Manufacturing Practice) standards and requirements that meet all FDA regulations.
AmbioPharm routinely produces biologically active peptides with lengths from 5 to 70 amino acids in length. Several commercial products are produced in quantities > 300 kg/annum.
AmbioPharm also partners with generic drug companies to develop generic peptide APIs for established commercial drug products in markets around the world.
AmbioPharm has more than a decade of experience manufacturing Active Peptide Ingredients (APIs) for peptide vaccines. These include Multiple-Antigenic Peptides (MAPs), peptide cocktails and more.
At the same time as the development process is underway, AmbioPharm will develop analytical HPLC (High Performance Liquid Chromatography) or UPLC methods and validation tools.