What’s happening: ICH Q1 is consolidating stability expectations
ICH has moved forward with a consolidated stability guideline, ICH Q1, intended to integrate core principles and annexes. A Step 2 draft guideline dated April 11, 2025 outlines stability data expectations for drug substances and drug products and notes the intent for a combined guideline with integrated annexes. (ICH Database)
Regulators are actively posting aligned materials:
- FDA published a draft guidance on Q1 stability testing on June 24, 2025. (S. Food and Drug Administration)
- EMA describes ICH Q1 as a consolidated revision that supersedes the Q1A–F and Q5C series and adds science- and risk-based principles. (European Medicines Agency (EMA))
Why this matters: stability is no longer just “3 batches and a calendar”
Sponsors and CDMOs have been moving toward risk-based stability strategies for years. ICH Q1 accelerates that convergence and creates a clearer reference point for:
- initial registration packages,
- post-approval changes,
- and master file expectations.
The Step 2 draft also explicitly notes applicability of stability expectations to materials produced using continuous manufacturing processes. (ICH Database)
Practical impacts for API and intermediate programs
1) Expect more explicit justification where you use reduced designs
If you bracket, matrix, or otherwise reduce protocols, the expectation will continue to be “justify with science and risk logic,” not “because it’s what we always do.”
2) Increased focus on lifecycle and post-approval changes
Stability packages increasingly need to anticipate:
- site changes,
- process improvements,
- packaging changes,
- and analytical method updates.
3) Stability-indicating methods become a strategic asset
As methods evolve under Q14/Q2(R2), stability and analytical strategies become intertwined. The strength of your stability-indicating approach often determines how painful lifecycle changes become.
A modern API stability framework (simple, defensible, and scalable)
Phase 1: Establish baseline degradation behavior
- Forced degradation (heat, light, oxidative, hydrolytic as relevant)
- Initial impurity mapping and likely pathways
Phase 2: Build the stability protocol around decisions
- What decisions must stability data support? (retest, packaging, shipping, hold times)
- Select timepoints and conditions to answer those decisions efficiently
Phase 3: Operationalize “stability governance”
- Trending and review cadence
- Clear rules for OOS/OOT and investigation triggers
- Simple reporting artifacts your team can re-use
Peptides and complex molecules: a specific note
For peptide APIs and reagents, your risk model often needs to explicitly address:
- oxidation-sensitive residues,
- deamidation,
- aggregation (where relevant),
- and moisture/temperature excursions during shipping.
Where Agere Sciences fits
Agere Sciences positions itself around APIs, research compounds, and CDMO services, and the site’s existing content footprint suggests your audience responds to practical quality frameworks. (Ageresciences)