All cGMP-grade peptide manufacturing is performed in strict compliance with 21 CFR parts 210 and 211. We pay close attention to compliance adherence and have instituted a continuous employee training program.
cGMP Peptide Manufacturing Process
Our facility can synthesize peptide batches from few milligrams to up to 2 kilograms. These peptides may be 50 or more amino acids in length, higher than 99% in purity. We can adjust the purity and single impurity percentage according to your specifications for each product.
Before we start the large-scale synthesis we conduct preliminary method development to find optimum synthetic strategies, protecting group combinations, activation methods, counterions, and solvents to ensure the most suitable and cost-effective manufacturing process for each specific API. If your peptide is difficult to synthesize by traditional methods, our experienced scientists will work on a customized protocol to help you achieve your goals.
We audit many of our raw material suppliers. Raw material COAs can be included in the product documentation. SOPs for the handling and testing of raw materials have been developed and are strictly followed.
We have the capacity to introduce a range of modifications to cGMP peptides. These include glycosylation, phosphorylation at serine, threonine, or tyrosine residues, amidation, acetylation, biotinylation, conjugation to FITC, ovalbumin, KLH or BSA, and multi-antigen peptide synthesis.
Our usual purification method is reverse phase HPLC, but several other methods are available, including ion exchange and size exclusion chromatography.
For quality control of the finished product, we test the following characteristics:
- Purity by gradient HPLC
- Molecular weight by mass spectrometry
- Peptide content
- Counterion content
- Water content
- Residual organic solvent content
- Trifluoracetic acid (TFA) content
- Endotoxin levels
- Organic volatile impurities by gas chromatography (GC)
- Thin-layer chromatography
- Other tests as required
The finished product is lyophilized under cGMP conditions inside clean rooms with their own air systems and packaged in a dedicated packaging operations room (grade A area).
We focus on establishing and maintaining efficient communication with our customers. A designated project coordinator will work with you to ensure that you have all the information you need at all stages of the project. You can also track your project on-line at any time using our project management system.
Our commitment to quality is the most important factor behind the growth and success of our cGMP peptide synthesis division.