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The process

From sequence to sealed vial

Every Lyotek peptide goes through the same five steps in one laboratory. Each step is recorded, and the record follows the lot all the way to its certificate of analysis.

  1. Synthesis

    Each peptide is built one amino acid at a time by solid-phase synthesis, following the sequence on its specification.

    The growing chain is held on a resin while each amino acid is coupled, washed and checked before the next one goes on. When the sequence is complete the peptide is cleaved from the resin as crude material, ready to be purified.

    Synthesis reactor with a glass vessel and copper fittings, running.
  2. Purification

    Preparative HPLC separates the target peptide from everything else the synthesis produced.

    The crude material is passed through a chromatography column and collected in fractions. Only the fractions that match the target are pooled, and the pool is checked again before it moves on.

    Preparative chromatography column on its stand, running.
  3. Freeze-drying

    The purified solution is frozen and dried under vacuum into a stable cake that keeps well in the cold.

    Lyophilisation removes the water without heating the peptide. The chamber runs a recorded cycle of freezing, primary drying and secondary drying, and the cycle record joins the lot's batch record.

    Freeze-drying chamber with its door and shelves, running a cycle.
  4. Fill and finish

    Vials are filled, stoppered and crimp-sealed, and each one carries its lot number on the label.

    Filling takes place in a classified cleanroom. Every vial is closed with a stopper and an aluminium crimp under a copper flip-off cap, then labelled with its product code and lot.

    Vial filling line indexing glass vials under the filling heads.
  5. Testing and release

    A lot is released only when its results meet the specification, and its certificate of analysis travels with it.

    Samples from every lot are tested on the analytical bench and the results are written up as a certificate of analysis. You can find the certificate for any lot from the code printed on its label.

    Analytical bench with an HPLC system and a sample tray, running.

Every lot ends with its certificate

Have a vial in hand? Enter the code printed on its label to find the certificate of analysis for that lot.