GMP Manufacturing

You are here: Home / Quality & Systems / GMP Manufacturing

Choice of Solution or Solid Phase Process

Solution Phase Process
Pro: uses relatively less solvent than solid phase, unlimited manufacturing scale >100kg, sometimes can avoid HPLC chromatographic purification.
Con: higher process development costs increasing exponentially with peptide length, slower development, less cost-effective for peptides longer than 20 amino acid residues, more difficult to revalidate at multiples of 10x increased scales.

Solid Phase Process
Pro: lower process development costs, faster development, cost effective for longer peptides up to 100kg scale, sometimes using fragment condensation .
Con: relatively higher volumes of solvent use, HPLC chromatographic purification required.

AmbioPharm Advantage – Low Cost of Manufacturing
  Closest to all major raw material manufacturing companies for amino acid derivatives and solvents.
  Lowest cost of solvents.
  Solvent recovery systems to further reduce manufacturing costs up to 50% on larger scales.
  Lowest cost of manufacturing with either solution or solid-phase synthesis under fully controlled cGMP system with seasoned management.

AmbioPharm Team’s Expertise
  Over 100 years of cumulative experience in process development, scale-up and cGMP manufacturing peptides.
  Developed, scaled up and manufactured up to 50 kg of peptide APIs by solid phase process.
  Developed, scaled up and manufactured up to 40 kg of peptide APIs by solution phase process.
  Developed and manufactured peptide conjugations to proteins, toxoids, antifungals, KLH, and PEG under cGMP.

Contact our team of experts to place an inquiry.

Contact Us

Browse our brochures to learn more about AmbioPharm.

Resource Center