Process & analytical development

Turn a promising sequence into a clear proposition.

We build the process understanding, analytical methods and documentation your peptide needs for regulatory filings and a smooth transition to GMP manufacturing.

01

Peptide impurity synthesis

Authenticated reference standards for impurities from synthesis, degradation or storage, fully characterised to support method development and regulatory documentation.

02

Process research & development

We identify and optimise critical process parameters, resins and reagents, work-up and purification to build robust, scalable routes with consistent quality.

03

Analytical method development

HPLC and UPLC methods, mass spectrometry, amino acid analysis, peptide content, MS-MS sequencing and physicochemical testing, designed with future validation in mind.

Our toolkit

Analytical and purification capabilities.

Analytical

  • Agilent 1290 UPLC systems with PDA, VWD and MS detection
  • LC-MS with mass deconvolution and MS/MS sequencing
  • High-resolution MS through the SMS Pharmaceuticals central lab in Gagillapur
  • Amino acid composition and chiral analysis
  • Peptide content, counter-ion content and water content (TGA)
  • Certificates of analysis tailored to your requirements

Purification & finishing

  • Biotage Selekt flash chromatography
  • Preparative RP-HPLC, up to 150 mL/min
  • Mass-directed preparative purification
  • Controlled lyophilisation
  • Counter-ion exchange to acetate, chloride, sodium and others
  • Scalable Fmoc SPPS routes from research scale to multi-gram
What you receive

Evidence for the next milestone.

  • 01
    Clear reports

    Development reports that explain what was done, what was learned and what comes next.

  • 02
    Certificates of analysis

    Characterisation data for every material we supply.

  • 03
    Transfer-ready methods

    Analytical methods and process descriptions ready for transfer to GMP manufacturing.

Develop with intent.

Build process understanding early and generate the documentation you need for the next milestone.