Recombinant peptides
Recombinant peptides are long-chain peptides produced through cellular expression systems. Unlike synthetic peptides, which are manufactured by chemical synthesis, recombinant peptides originate from biological processes. This biotechnological production enables greater structural diversity and functionality, making recombinant peptides highly promising in the development of innovative medicines in oncology, immunology and metabolic disorders.
However, their biological origin also introduces additional complexity. Residual host cell proteins (HCPs) and residual DNA must be carefully monitored, while complex folding patterns and structural heterogeneity increase the risk of aggregation. These challenges require extensive purification steps and a dedicated analytical strategy that combines both chemical and biological expertise.
At Quality Assistance, we provide the integrated and regulatory-ready solutions you need to overcome these hurdles and accelerate your recombinant peptide development.
Analytical challenge we solve
The development of recombinant peptides presents unique analytical challenges. Their complex molecular structures must be confirmed at both the primary and higher-order levels, while post-translational modifications and aggregation tendencies add to the variability that must be carefully controlled.
The use of cellular expression systems leads to process-related impurities such as residual host cell proteins and DNA, which need to be quantified to meet stringent regulatory requirements. In addition, their purification needs are greater than those of synthetic peptides, often involving multi-step workflows that must be fully supported by sensitive analytical techniques. Finally, quantitative analysis in biological matrices for pharmacokinetic and toxicokinetic studies requires tailored approaches to ensure precision and reliability.
| Intact peptide | (U)HPLC (UV, RI, fluo, MS) / CE |
|---|---|
| Molecular weight | ESI-MS / MALDI-TOF |
| Peptide mapping and/or sequencing | UPLC (UV, MSE) |
| Immunological identification | ELISA-based platforms |
| Assay | UV / (U)HPLC (UV, RI, fluo, MS) |
|---|---|
| Determination of extinction coefficient | UV + ICP-MS/MS (isotope dilution) |
| Purity profile | IEX / RP-(U)HPLC (UV, MS) / icIEF |
|---|---|
| High order structure | CD / FT-IR |
| Mass distribution profile | ESI-MS / MALDI-TOF / SEC-(U)HPLC / UV |
| Chemical modifications | (U)HPLC (UV, MS) / CE (UV, LIF) |
| Degradation patterns (Oxidation, deamidation, truncation) | IEX / RP-(U)HPLC (UV, MS) / CE (icIEF, cGE) |
| Aggregation and particle size distribution | AF4 & SEC-(U)HPLC (UV, RI, MALS) / DLS / Imaging Particle Analysis |
| Disulphide bridges | Peptide mapping (UPLC-UV/MS) / SDS-PAGE / cGE |
| Free thiols | Fluorescence (NPM) / UV (Ellman) |
| Enantiomeric purity | (U)HPLC-UV / Fluorescence / GC-MS / CE |
| Counter-ion content (Mass balance) | (U)HPLC (UV, MS) / ICP (OES, MS) |
| Immunoassays | ELISA / ECL (MSD) / Luminex / SPR (Biacore) / BLI (Octet) |
| Cell-based assays (Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc.) | Different read outs |
| Microbiology | Bioburden / Sterility (filtration, direct inoculation) |
| Endotoxins and pyrogens | LAL (kinetic, end point) / rFC / MAT |
| Elemental Impurities | ICP-MS |
| Residual proteins (recombinant peptides) | ELISA / ECL (MSD) / Luminex / Gyrolab / UPLC-MS / Western blot / 2D-DIGE |
| Residual DNA (recombinant peptides) | qPCR / ddPCR / PicoGreen |
| Leachables | GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS) |
|---|---|
| Container Closure System Integrity | Bubbling / Dye ingress (methylene blue, fluorescence) / Microbial ingress |
| Cytotoxicity / Biological reactivity | Cell-based assays / USP <87> |
| Break Loose and Glide Force (BLGF) for prefilled syringes |
Analytical platforms and technologies
We offer a powerful array of analytical platforms specifically optimised to meet the rigorous demands of recombinant peptide development:
- Advanced separative techniques including SEC, HIC, RP-UPLC(/MS), CGE, and icIEF for detailed purity, aggregation and impurity profiling.
- High-resolution mass spectrometry platforms such as the Waters Xevo G2-XS QTof or BioAccord, for intact mass analysis and sequencing, and Bruker autoflex maX MALDI/TOF for the characterisation of delayed-release PEGylated peptides
- Aggregation and particle analysis with SEC-MALS, AF4-MALS, Dynamic Light Scattering (DLS) and flow imaging allows reliable detection of fragments, soluble aggregates, and sub-visible particles, critical for ensuring safety and efficacy.
- In vitro potency and binding assays, including Biacore (SPR), Octet (BLI), Gyrolab and functional cell-based assays, provide robust evidence of biological activity and mechanism of action.
- Immunoassay technologies such as ELISA, MSD, Gyrolab and Luminex, as well as UPLC-MS/MS, for both API assay and sensitive detection of impurities such as residual host cell proteins.
- qPCR and Picogreen for the precise quantification of residual host cell DNA.
Bioanalytical services
We provide quantitative analysis of recombinant peptides in biological matrices, conduct pharmacokinetic and toxicokinetic studies and perform biomarker analysis with multiplexed immunoassays and LC-MS/MS platforms.
In parallel, we implement immunogenicity testing through ELISA, MSD, and Gyrolab to detect, quantify and characterise anti-drug antibodies (ADAs).
Accelerating recombinant peptide development with Quality Assistance
By partnering with Quality Assistance, you gain access to advanced analytical technologies and multidisciplinary expertise in both chemical and biological sciences. We help you navigate the complexity of recombinant peptide development, address your analytical challenges with precision and accelerate your path to market with confidence.