GMP Services


AmbioPharm has multiple FDA-inspected manufacturing suites capable of producing peptide APIs (Active Pharmaceutical Ingredients) at varying scales from gram to multi-kilogram scale.  We use solid phase synthesis, solution phase synthesis (also referred to as liquid phase peptide synthesis or lpps), and hybrid solid/solution phase synthesis to produce GMP peptide APIs.

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.

In addition, AmbioPharm is an experienced provider/producer of:

CEM microwave peptide synthesizer in AmbioPharm peptide lab

AmbioPharm is one of the world’s largest custom peptide producers. We can produce nearly any type of peptide and special modification(s) that you need. Whether it be a fatty acid acylation or a high molecular weight pegylation, we have the experience and know-how to produce your product.

AmbioPharm peptide synthesis lab equipment

From preclinical to commercial, AmbioPharm has multiple manufacturing suites capable of handling any project scale.

AmbioPharm peptide synthesis chemist and lab equipment

AmbioPharm is capable of producing biologically active peptides with target length from 5 -70 amino acid residues. Peptides with multiple disulfide bonds, such as toxins, are a particular strength of ours.

FDA Compliant Practices

All of our processes comply with cGMP (current Good Manufacturing Practice) regulations as required by the FDA, including successful US FDA inspections at both sites.  These regulations assure proper design, monitoring, and control of manufacturing processes and facilities.  AmbioPharm’s quality process assures the identity, strength, quality, and purity of the products we manufacture. 

Our Quality Control Department continuously monitors production.  Using quality controls, scientifically sound design practices, processing methods, and testing procedures, we are continuously improving our processes.

Peptide Manufacturing in the USA

Our peptide manufacturing facilities in North Augusta, South Carolina use cGMP methods for quality.

  • Purification scale from grams to 30kg per batch
  • Preparative HPLC columns up to 100cm
  • Lyophilization capacity up to 1,000L

Peptide Manufacturing in China

Our facilities in Shanghai, China also employ cGMP methods that meet FDA regulations and requirements.

  • Reactors from 500L to 5,000L
  • Vacuum ovens from 50L to 1,000L
  • Continuous Flow Centrifuges
  • Thin film evaporators
  • 500L reactor for hydrogenation
  • Up to metric tons of APIs and intermediate
  • Preparative HPLC columns up to 45cm
  • Lyophilization up to 200L

SETTING A NEW STANDARD

For Peptide API Manufacturing and Services

Have a Peptide project?