Frequently Asked Questions
Questions About our Peptide and Oligonucleotide CDMO Services

CDMO Services

What is a CDMO in the context of peptides and oligonucleotides?

We offer comprehensive support from discovery and preclinical development, through clinical phases (Phase I–III), to commercial manufacturing and supply chain management.

What stages of drug development do you support?

We offer comprehensive support from discovery and preclinical development, through clinical phases (Phase I–III), to commercial manufacturing and supply chain management.

Do you handle both generic and proprietary (NCE) peptides/oligonucleotides?

Yes, we specialize in both generic APIs and novel chemical entities (NCEs), including complex conjugates and modified structures.

How do I start a project?

Please share your sequence (or let us know if you’d prefer to keep it confidential until an NDA is in place), along with your specifications and project stage. We’ll promptly prepare a tailored proposal and NDA for your review and discussion.

Peptide Manufacturing

How are peptides synthesized?

With very few exceptions, most peptides at Sinopep are synthesized using chemical methods. The source of each peptide—synthetic or recombinant—is clearly indicated in the product description, with recombinant products explicitly designated as recombinant peptides (rec).

Sinopep’s peptides are produced by chemical peptide synthesis, in which amino acids are assembled stepwise from the C-terminus to the N-terminus. Depending on the sequence and application, peptides are manufactured using solid-phase peptide synthesis (SPPS), liquid-phase (solution-phase) synthesis, or hybrid approaches that combine both methods. These complementary strategies allow efficient production across a wide range of peptide lengths and complexities.

What is the difference between 'research- and GMP-grade' peptides or oligonucleotides?

Research-grade peptides are strictly for laboratory and research use only and are not intended for human or therapeutic applications. GMP-grade APIs, by contrast, undergo rigorous monitoring for chemical and biological contaminants to ensure safety and suitability for human use.

How do you ensure peptide purity and quality?

Our CGMP specifications and testing procedures include the following:

  • Appearance: Solid, off-white to white
  • Solubility: Clear solution at specified concentration
  • Purity (HPLC/UPLC): 95–98% (phase-dependent)
  • Molecular Weight (MS) / AAA: Within ±10% of theoretical value
  • Peptide Content: ≥70%
  • Counter-Ion Content: Report
  • Elemental Impurities (ICP-MS): Report Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, Sn
  • Endotoxin: Report LAL (Gel Clot) per USP
  • Bioburden: Report aerobic and spore counts per USP
  • Residual TFA: ≤0.1%
  • Residual Solvents: GC-MS, report
  • Moisture (Karl Fischer): ≤10%

Handling of Peptides

How are peptides synthesized?

With very few exceptions, most peptides at Sinopep are synthesized using chemical methods. The source of each peptide—synthetic or recombinant—is clearly indicated in the product description, with recombinant products explicitly designated as recombinant peptides (rec).

Sinopep’s peptides are produced by chemical peptide synthesis, in which amino acids are assembled stepwise from the C-terminus to the N-terminus. Depending on the sequence and application, peptides are manufactured using solid-phase peptide synthesis (SPPS), liquid-phase (solution-phase) synthesis, or hybrid approaches that combine both methods. These complementary strategies allow efficient production across a wide range of peptide lengths and complexities.

What is the difference between 'research- and GMP-grade' peptides or oligonucleotides?

Research-grade peptides are strictly for laboratory and research use only and are not intended for human or therapeutic applications. GMP-grade APIs, by contrast, undergo rigorous monitoring for chemical and biological contaminants to ensure safety and suitability for human use.

How do you ensure peptide purity and quality?

Our CGMP specifications and testing procedures include the following:

  • Appearance: Solid, off-white to white
  • Solubility: Clear solution at specified concentration
  • Purity (HPLC/UPLC): 95–98% (phase-dependent)
  • Molecular Weight (MS) / AAA: Within ±10% of theoretical value
  • Peptide Content: ≥70%
  • Counter-Ion Content: Report
  • Elemental Impurities (ICP-MS): Report Sb, As, Bi, Cd, Cu, Pb, Hg, Mo, Ag, Sn
  • Endotoxin: Report LAL (Gel Clot) per USP
  • Bioburden: Report aerobic and spore counts per USP
  • Residual TFA: ≤0.1%
  • Residual Solvents: GC-MS, report
  • Moisture (Karl Fischer): ≤10%

Still need help? Send us a note!

For any other questions, please write us at tides@sinopep.com.