Service & Products
Peptide Modification
Every peptide (including crude) is shipped with an analytical data package that consists of (1) a certificate of analysis, (2) RP-HPLC (reverse-phase high-performance liquid chromatography), and (3) a solubility test data. We perform the solubility tests to find the optimal solvent conditions to solubilize your peptide so you can save time and material. The test utilizes solvents that are applicable to your experiment (water is the first choice) and can be customized according to your specifications. Additional analytical tests are available at your request, including Amino Acid Analysis (AAA), peptide, and moisture content (Karl Fisher).
i.Lactam Cyclization
ii.FRET Substrates
iii.Isotope-labeled Peptides
iv.Peptide Stapling
v.Peptide Macrocycles
vi.Click Peptides
vii.Dye and Fluorescent Labels
viii.PEGylation (mono- and polydisperse)
ix.Multiple Disulfide Bonds
xii.Sulfation and Sulfonation
xiii.Incorporation of Unnatural Amino Acids
xv.N-Terminal Modifications
xvi.C-Terminal Modifications
xvii.Hydrophobic Sequences
xviii.Rhodamine 110 Labeled
xix.Native Chemical Ligation
xx.Epitope Mapping
xxii.Multiple Antigenic Peptides (MAPs)
xxiii.Maleimide Group Installation
Comprehensive peptide process development capability
Our peptide API process development and GMP manufacturing platform provide end-to-end solutions to support your needs from preclinical to commercial stage.
For peptide API process development, we have a highly experienced R&D team with state-of-the-art equipment.
We have the capability both in the solid phase and liquid phase chemistry.
GMP manufacturing capacity
We are determined to be your strategic partner for reliable, cost-effective, and long-term partners for your peptide API manufacturer from grams to kilograms. All work is done from the single site, ensures knowledge retention and seamless scale-up throughout your product life cycle, and expedites your development by eliminating the need for multi companies/site transfer
Drug product (sterile injectable formulation development)
Our injectable platform provides formulation development and manufacturing for a solution, emulsion, lyophilized powder, and liposome in the vial, prefilled syringe, and cartridge.
Analytical development
Service overview
Biopeptek has a dedicated peptide analytical team of 70+ scientists with extensive experience and expertise to support all peptide analysis at all development phases. Our analytical service will streamline your peptide development with customized, flexible, and integrated analytical solutions.
Our services included
Method development and validation
Stability study: forced degradation study, accelerated and long-term stability study under R&D and GMP environment
Purity and Assay, residual solvents, moisture, cation content, anion content, aggregation content, elemental impurities
Microbiology safety: endotoxin for limit and quantitation and bioburden for microbial limit test
Amino acid analysis and enantiomeric purity: acid hydrolysis and derivatization followed by LC-MS analysis to accurately evaluate the amino acid ratio and D-isomer impurity amount in the peptide sequence
Identity by peptide mapping: enzymatic digestion followed by LC-MS analysis for characterization and confirmation of peptide API
Analytical capability
  • Appearance
  • Solubility
  • Peptide purity (HPLC)
  • Related substances (HPLC)
  • Molecular weight (MS)
  • Peptide content
  • Amino Acid Analysis
  • Counterion content
  • Moisture content (Karl Fisher)
  • Residual Trifluoroacetic acid
  • Residual organic solvents
  • Bioburden
  • Endotoxin
CMC filing
Service overview:
Biopeptek’s regulatory team offers documentation support for IND and NDA applications globally. Our team has experience preparing Module 2 and Module 3 of your regulatory dossier.
  • Batch record review
  • Document management and control
  • Deviations/Investigations
  • CAPA follow-up and tracking
  • Complaint management
  • Product release
  • Phase appropriate control systems consulting
  • CMC compilation
  • DMF compilation and submission
  • Annual product reviews
Therapeutic Peptides
Cosmetic Peptides
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Manufacturing capacity
SPPS, LPPS, ligation chemistry, and fragment condensation methodologies
All protecting strategies (Boc, Fmoc, Cbz) can be used
Process development and scale-up competence ensure a robust commercial process
GMP batch sizes from gram scale to multi-kilogram scale (5kg/batch)
IQ, OQ, PQ qualified equipment
Class 100K and 10K clean room
cGMP Compliance
Biopeptek cGMP quality program strictly follows FDA cGMP guidance
Code of Federal Regulations Part 210/211 (21 CFR 210/211)
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