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GMP Peptides
Offering Solutions from R&D to Commercial Production
Whether you are discovering new molecules or ready to commercialize, we can help.
What We offer
Efficient
Most efficient and green based peptide production
Fast
Extremely rapid turnaround time with microwave technology
Expertise
Full expertise in Chemistry Manufacturing and Controls (CMC) development
FDA Compliant
GMP Manufacturing in an FDA Audited U.S. based manufacturing facility
CEM and AmbioPharm Partnership
Through a partnership formed in 2021, CEM & AmbioPharm now offer the most advanced manufacturing process for the production of peptide based NCE’s. This is the result of combining CEM’s unique solid phase peptide synthesis (SPPS) technology with AmbioPharm’s expertise in peptide purification and GMP compliance.Watch the video
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FDA-Inspected Manufacturing Facility
High quality manufacturing
The use of microwave technology has dramatically impacted SPPS. It allows for major improvements in peptide purity, synthesis speed, and solvent reduction with easy use of greener solvents. Until recently, microwave enhanced peptide synthesis was limited to the R&D scale where it had gained widespread adoption. In 2018, CEM developed the world’s first large scale automated microwave peptide synthesizer allowing for kilogram scale production of peptides. This changed the landscape for production of peptide based NCE’s by allowing for major cost and speed improvements. The result is a much faster delivery of your peptide NCE with a more environmentally friendly and cost effective process than previously possible.Production of all peptides takes place at AmbioPharm’s FDA-inspected manufacturing facility in North Augusta, SC. The facility totals around 84,550 sqft in size and houses dedicated suites for peptide production operating under Q7 Good Manufacturing Practices (GMP) for Active Pharmaceutical Ingredients established by the FDA. The facility was recently expanded in 2020 and includes capacity for peptide synthesis, purification, formulation, and final product development. The Quality Control and Microbiology labs within the facility are supported by more than 40 experienced Quality Assurance members.
