Enhanced Diagnostic Tools
Synthetic peptides have proven to be very valuable in most biomedical laboratories; since the mid-60’s , to the present biologically active peptides have been integrated into the growing number of API’s (active pharmaceutical ingredients) and as stand alone products also( Vasopressin, Gonadorelin, Leuprolide, Goserelin.among others); with the completion of the human genome, and the confirmation of abut 30,000 proteins produced in the human body, there are now many more targets for the biomedical researcher to explore.
Generally the biomedical researcher will explore the possibility to increase the native potency of a given peptide/protein, by rationale design; to this end. Small amounts of peptide are needed, more likely in the milligram scale. Once a desired activity/potency is found, then a larger scale of synthesis is need, usually in the gram/grams scale, in order to initiate small animal studies. Upon successful validation, then even larger scale of synthesis are desired, this can range from hundreds of grams to multikilo amounts.Bio-Synthesis has over 25 years of experience in the custom synthesis, from research grade scale, all the way to multikilo amounts.
Large scale peptide synthesis can be carried out either in solution or in solid phase; generally peptides shorter than 8 amino acids are prepared by solution chemistry, as it is usually more economical to do so. Peptides larger than 8 residues are generally assembled by solid phase chemistry; commercially peptides up to about 50 residues in length; once a pilot run is established and it is determined that a high load resin can work(about 1 mmmol/gram) good yields can be obtained for short peptides (8-20); above 20 residues a good balance of resin loading and possible steric hindrance problems needs to be analyzed. Solid phase synthesis can be carried out either in a fully automated fashion or manually; again manual synthesis for short peptides have the advantages of being able to scale up with more flexibility and be more able to troubleshoot unexpected problems; the operator can wash away piperidine during Fmoc deprotection, in the event of power failure or machine troubles (in the case of an automated instrument). Also the thermodynamic mixing can be better controlled in manual systems. We are not saying that manual systems are better, we are saying that for shorter and multikilo (10-20 kgs runs) solid manual methods are a good alternative. Large scale fully automated peptide instruments, have the obvious advantage of unattended operation and extensive documentation and for longer and mid-scale synthesis provide a generally reliable venue.
Large scale peptide synthesis manufactured under GMP conditions will also include the following documentation, as part of the quality control assays:
MS for Identity
± 1 amu.
RP-HPLC for purity
AAA for Identity
± 15% of theory
Nitrogen analysis for peptide content
Karl Fischer for water content
Residual solvents test
Quantification of Counter Ion
Bacterial Endotoxin, LAL test
≤ 0.25 EU / mg
≤ 10 CFU / 100 mg
Bio-Synthesis has been producing synthetic peptides for over 25 years. Our expertise in custom synthetic polypeptide manufacturing allows us to produce the high-quality, large-scale, and GMP peptides with the highest success rate with long standing records. We have been delivered more than 100,000 peptides to customers worldwide, including very hydrophobic polypeptide, peptide with multiple disulfide bonds, multi-phosphorylated peptides and extremely long peptides. Our large scale non-GMP ever delivered 5 kilograms of peptides on a single order and has the capacity of 10,000 peptides per month. Our capacity of GMP peptide is 10 kilograms.
Whenever your research work may require large scale synthesis of peptides, please keep us in mind, Bio-Synthesis Inc. staff will be glad to help you achieve your research/production goals.
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