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Research Grade

Global Peptide supplies strictly research grade peptides which are not for human consumption.  When considering peptide development for possible cGMP production, it is important to keep these things in mind:

  1. Consulting peptide chemists with ample bench experience is very important, because although some peptides that build well at small scales, many do not build well when production quantities are increased.  Also, chemistry cost for modified peptides must be considered and alternate strategies discussed so that the scale-up is not prohibitive.

  2. cGMP compliance is not the same as certification, and because many companies claiming cGMP do not have to be certified, it can be questionable if they are in fact compliant.  It is on the onus of the customer to ensure that the specific cGMP requirements are met for their particular peptide and the application in which it is used, and an audit of the cGMP facility is highly recommended before work is agreed upon.  cGMP guidelines for your projects should follow Manufacturing under FDA regulations 21 CFR parts 210 and 211, and an FDA representative should be contacted prior to cGMP initiation, as therapeutic vs. diagnostic applications may differ.  For example, research grade peptide material may be suitable for use in a diagnostic kit, but the kit must be assembled under cGMP guidelines.  Alternately, a MAP peptide could require significantly different guideline requirements than standard, linear peptides.  One may also be able to complete a large amount of toxicology and dosage studies before cGMP is required.
  3. Obtaining high purity material for research grade products is valued not only because of specificity and activity, but because cGMP requirements set forth by the FDA in later clinical stages may allow for a relaxing of the purity, which is valuable in manufacturing cost structures.  Thus, addressing the range of activity at different purity levels and adequate amounts of specific contaminants will standardize optimal requirements.
  4. Determining a research grade company and cGMP provider that communicates well with each other and with the client is paramount.  Strong synergy in company culture, communication and data acquisition can make or break a project. 

Global Peptide will gladly enter into CDA agreements with interested companies for consultative and/or production relationships.  Contract Research agreements are currently ongoing and we welcome new project discussions.  The cGMP organizations that Global Peptide partner with are, we believe, less restrictive and more client friendly than many competitor companies that offer all services internally.  Please contact us with your enquiries.