Speciality Chemicals Magazine MAR / APR 2026 | Page 34

Orthogonal analytical strategies for peptide stability

Dr Achim Link, field development manager at Solvias, explains how orthogonal analytical testing de-risks peptide development by capturing stability profiles under formulation-relevant conditions

Peptide therapeutics are reshaping clinical medicine, from GLP1 receptor agonists now produced at multibillionunit scales to cyclic and stapled peptides and peptide – drug conjugates entering latephase trials. No single analytical readout, however, captures the multidimensional stability risks these molecules face during development, formulation, storage and delivery.

Small chemical changes can shift self-association equilibria. Physical stresses, including interfaces, agitation and temperature excursions, can promote chemical change( i. e. decomposition) by altering local environments, introducing leachables or increasing exposure to susceptible residues. In practice, a single method rarely gives a defensible
Figure 1 Above- Stability risks across all development stages Figure 2 Below- Decision-led peptide stability studies across development
Smart candidate selection
• Identify the most stable peptide sequences early.
• Apply stress tests and forced degradation studies to guide decision-making.
Formulation optimization
• Compare formulations to determine which best preserves stability.
• Identify most critical parameters from the start.
Drug product stability
• Assess long-term stability.
• Establish expiry date, evaluate impurity risks, and support regulatory submissions.
Stress testing
Accelerated testing
Container integrity & device testing
Long-term testing
Customised protocols
Forced degradation studies: light exposure, heat, oxidation, acid / base
Temp. cycles, excipient screening, ref. standards cone., pH comparitive studies,
Container closure testing, syringe testing, extractables & leachables
lntermed. to long-term, in-use testing, product monit., post-approv. changes
CSOPs, Flexible study design, GMP quality, reports aligned to( regulatory) expectations
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