The API Model


AmbioPharm is one of the largest capacity peptide manufacturers in the world. Our management team has more than 150 years of cumulative experience in peptide development and manufacturing. 

In addition to a stellar reputation in the industry, here are three reasons you should consider AmbioPharm:

Unique Business Model

AmbioPharm has developed a unique business model designed to expedite peptide manufacturing.  We can handle any scale project from small (mg quantities) to large commercial quantities (>100kg). By streamlining our chemical synthesis operations at the source where nearly all of the key raw materials are produced, we are able to save our partners cost-of-goods by passing on these savings to them.

We can produce the highest-quality products of any scale at a lower price than most of our competitors.  Our custom non-GMP peptides can be reviewed and released by our in-house Quality Control Unit in as little as 3-4 weeks.

Peptide Manufacturing Process

We can perform solid-phase, solution-phase or hybrid peptide chemistry plus organic conjugations to proteins, toxoids, antifungals, KLH (Keyhole Limpet Hemocyanin, and PEG (Polyethylene Glycol).

Our peptide development services go from preclinical to commercial development through the entire process from scale up to process qualification to process validation prior to NDA (New Drug Application) with the Food and Drug Administration.

We follow cGMP (Current Good Manufacturing Process) guidelines required by the FDA for peptide manufacturing.  In addition to contract peptide API manufacturing, we can also produce generic peptides for established commercial markets and non-GMP peptides for clinical research.

Analytical Development & Validation

At the same time as the development process is underway, AmbioPharm develops analytical HPLC (High 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.

Synthesis Manufacturing Capacity

Under current facilities, AmbioPharm has the capacity to handle any project at scale.  The new commercial building in Shanghai added 4 additional manufacturing lines to increase overall capacity in 2017.

  • 30 solid phase reactors
    1L, 5L, 10L, 30L, 50L, 80L, 200L
    (Up to 20 kg crude/batch)
  • 20 solution phase reactors
    10L, 20L, 30L, 50L, 80L, 200L
    (Up to 40 kg crude/batch)
  • 1000L solid phase reactor
    (Up to 100 kg crude/batch)
  • 5000L solution phases reactor
    (Up to 200 kg crude/batch)

Purification Scale

Purification scales range from 1g to 30 kg/batch final peptide.

  • ID:  5, 8, 15, 20, 30cm HPLC Column
    (Up to 7 kg/batch and 100 kg/year)
  • ID:  45cm HPLC Column
    (Up to 15 kg/bath and 120 kg/year)
  • ID:  60cm HPLC Column
    (Up to 28 kg/batch and 200 kg/year)

Locations & History

AmbioPharm was founded in 2006 and is one of the largest capacity peptide manufacturers in the world.  With facilities in North Augusta, South Carolina, and Shanghai, China, we employ more than 500 chemists and industry professionals.

Our cGMP peptide manufacturing facilities in the US and China can handle any manufacturing scale required.  We currently operate multiple manufacturing lines capable of sustaining campaigns from grams to 400 kg/year.  For commercial products, we design dedicated facilities at even larger scales to meet current and future needs of our clients.

SETTING A NEW STANDARD

For Peptide API Manufacturing and Services

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