AmWiner is one of the largest manufacturers of NCE peptides and generic APIs peptides in the United States. Our management team boasts over 15 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 Raphegenerics:
Unique Business Model
Raphegenerics has developed a unique business model designed to expedite peptide manufacturing. We can handle any scale project from small (gram 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 can save our partners cost-of-goods by passing on these savings to them.
Peptide Manufacturing Process
We can perform solid-phase, solution-phase, or hybrid peptide chemistry, as well as organic conjugations, on 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 before 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 and both sites are successfully inspected by the US FDA. In addition to contract peptide API manufacturing, we can also produce peptide APIs for established commercial markets and non-GMP peptides for clinical research. Each project is assigned a project manager committed to your project, giving it the attention required to meet your needs.
Analytical & Process Validation
At the same time as the development process is underway, Raphegenerics develops analytical HPLC (High Performance Liquid Chromatography) methods and validation tools. These tools will monitor the process for side reactions, ensure the required purity standards are met, and limit any residual impurities in the product. Controlling the final API to provide the necessary quality attributes, we will minimize process and degradation impurities. This affords formulators the maximum labeled drug shelf life under proper storage conditions.
Synthesis Capacity
Under current facilities, Raphegenerics has the capacity to handle any project at scale. The new commercial building in Garland, Texas, added 6 additional manufacturing lines to increase overall capacity in 2022.
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)
Purification Scale
Purification scales range from 1g to 10 kg per batch of 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/batch and 120 kg/year)
ID: 60cm HPLC Column (Up to 28 kg/batch and 200 kg/year)
ID: 100cm HPLC Column
Locations & History
Raphegenerics was founded in 2005 and is one of the world’s largest peptide manufacturers by capacity. With a US Headquarters and facilities in Garland, we employ more than five biochemists and industry professionals. In 2021, Raphegenerics established a larger European sales presence to serve our European customers better. Our cGMP peptide manufacturing facilities in the US can handle any manufacturing scale required. We currently operate multiple manufacturing lines capable of sustaining campaigns ranging from grams to 100 kg per year. For commercial products, we design dedicated facilities at even larger scales to meet the current and future needs of our clients.
Contact: [email protected] for NCE Peptides