Can you synthesize peptides with post-translational modifications?
Yes, we can synthesize peptides with a variety of modifications including post-translational modifications (PTMs). Some of the post-translational modifications that we can perform as a part of our peptide manufacturing servicesare:AcetylationCyclizations (including disulfide bonding, stapling)Fatty
Continue ReadingDo you make peptides as a starting material for radiolabeled peptides?
LexinPharma can manufacture chelator-modified peptides as a starting material for radiolabeled peptides or peptideradiotracers. Some examples include synthesis of DOTA/NODAGA-functionalized peptides. These peptides arethen often later radiolabeled with 68Ga or 177Lu and used for tumor imaging for di
Continue ReadingWhat synthesis approach should be taken for a toxicology (tox) and Phase I batch?
There are typically 2 approaches for a tox and Phase I batch. Here are a few guidelines:Two batch approach:A tox batch (nonGMP with batch records, additional release testing, and purposefully targets a lower purity) for aGLP tox study, followed by a cGMP clinical batch for a Phase 1 clinical trial (
Continue ReadingWhen do I need cGMP peptides?
A question we often get asked is when do I need cGMP peptides? Here is a guideline:Preclinical studies: research grade peptide (nonGMP) is sufficient for nearly all cases. Toxicology (tox) batch: If there are no plans for use of the batch in Phase I studies, research grade (nonGMP)material is accept
Continue ReadingWhich salt form should I choose for my peptide?
When developing your peptide, you will need to select a salt form which is acceptable for your future clinical studiesor desired application. Most peptides form salts if they contain a free amino group (found in a free N-terminus or on a side chain that has afree amine, for example, Arg, Lys, and Hi
Continue ReadingWhat does cGMP mean?
cGMP refers to the current Good Manufacturing Practice regulations enforced by the U. S. Food and DrugAdministration (FDA) under the Federal Food, Drug, and Cosmetic Act. The regulations are in 21 CFR, parts 210and 211. The purpose of these regulations is to assure the identity, strength, quality, a
Continue ReadingWhat quality control data do you provide for non-GMP grade peptides?
Quality control (QC) data provided with every non-GMP grade peptide includes mass spectral (MS) and HPLCanalyses determining composition and purity. Amino acid analysis (AAA) and peptide content are available uponrequest with an added cost for each test. We also provide storage and handling guidelin
Continue ReadingWhat is the advantage of capping the N and C termini of the peptide?
cGMP refers to the current Good Manufacturing Practice regulations enforced by the U. S. Food and DrugAdministration (FDA) Acetylation or capping of the N-terminus will make a peptide appear more like native protein. Italso helps to minimize amino peptidase degradation of the peptide. Amidation of t
Continue ReadingWhat does cGMP mean?
cGMP refers to the current Good Manufacturing Practice regulations enforced by the U. S. Food and DrugAdministration (FDA) under the Federal Food, Drug, and Cosmetic Act. The regulations are in 21 CFR, parts 210and 214. The purpose of these regulations is to assure the identity, strength, quality, a
Continue ReadingWhat purity percentage is required?
The required peptide purity percentage depends on your specific application. LexinPharma can synthesize peptidesup to >98% purity. These are some general guidelines for peptide purity requirements:PurityPeptide Application or Use>80%Immunological applications and polyclonal antibody production
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