Resources

We share practical knowledge and examples so you can make informed decisions.

What You’ll Find:

Regulatory Guidance Summaries

Clear explainers of ICH and pharmacopeia requirements
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Analytical Methodology Insights

Tips and techniques for better testing
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Case Studies

Examples of successful projects
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Regulatory Guidance Summaries

Pharmacopeia Highlights (Ph. Eur. vs USP) — Where It Matters for Global Submissions

Concise differences in protein/peptide analytics for compendial filings.

Key takeaways:

  • System suitability, column options, reporting nuances
  • Harmonization tips to avoid re-validation
  • Reviewer-friendly reporting conventions

Full guide includes:

Side-by-side method examples and harmonization checklist.
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ICH Q5C: Stability of Biotechnological Products — A Practical Planner

Step-by-step view of real-time, accelerated, and forced degradation for biologics, integrating RP-HPLC/SE-HPLC, LC/MS, and DSC/CD/DLS.

Key takeaways:

  • Picking meaningful CQAs and timepoints
  • When DSC adds value
  • Reporting stability for comparability and biosimilars

Full guide includes:

Example ICH matrices, pull-point plans, stability report shell.
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ICH Q2(R2): Analytical Method Validation — What Changed & What It Means

Updates modernize validation for chromatographic and MS-based methods. Explains how to evidence specificity for complex proteins/peptides, treat reporting/decision rules, and plan robustness without over-testing.

Key takeaways:

  • Mapping Q2(R2) terms to HPLC/LC-MS workflows
  • Practical templates for accuracy/precision/linearity and LOD/LOQ
  • Linking validation outputs to Module 3/IMPD expectations

Full guide includes:

Protocol checklists, example acceptance criteria, sample data tables, validation report outline.
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Analytical Methodology Insights

Higher-Confidence Peptide Mapping (LC/MS) — Coverage, PTMs, and Pitfalls

Improving digestion efficiency, coverage, and PTM detectability; managing missed cleavages and oxidation artifacts.

Key takeaways:

  • Enzyme choice and best practices
  • Gradient, flow, and MS settings for PTMs
  • Data review workflow for regulatory scrutiny

Full guide includes:

Example sequence maps and QC acceptance criteria.
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DSC in Stability Studies — Seeing Thermal Transitions That HPLC Misses

How DSC complements chromatographic/MS data by revealing unfolding, domain stability, and subtle structural changes.

Key takeaways:

  • Designing DSC runs (scan rate, buffers, repeats)
  • Linking Tm/ΔH shifts to formulation or stress
  • Including DSC in validation/transfer package

Full guide includes:

Example thermograms and reporting template.
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RP-HPLC vs SE-HPLC — Complementary Views of Protein Quality

When to use each, what each reveals, and how to align outputs with PTM or intact-mass findings.

Key takeaways:

  • Column/mobile phase choices that reduce artifacts
  • Interpreting peak shape, tailing, recovery
  • Hand-off into validation and QC transfer

Full guide includes:

Method skeletons, troubleshooting tree, SST examples.
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Case Studies

Peptide Therapeutic: Mapping Revealed a Critical PTM Early

Optimized mapping uncovered a low-level PTM that explained potency drift.

Key takeaways:

  • Sample handling for labile PTMs
  • Read-across to formulation strategy
  • Communicating risk and resolution

Full guide includes:

Anonymized chromatograms, spectra, risk table.
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Method Validation for Intact Mass — Built to Transfer to QC

Validation parameters that make intact-mass MS robust across instruments/labs.

Key takeaways:

  • Specificity with look-alike variants
  • Precision & mass accuracy targets
  • Clean transfer package for QC

Full guide includes:

Example validation matrix and report excerpt.
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Biosimilar Comparability: Stability Story That Satisfied Reviewers

How combined RP/SE-HPLC + LC/MS + DSC demonstrated comparability vs. reference.

Key takeaways:

  • Choosing CQAs that matter
  • Turning raw data into reviewer-friendly narratives
  • Minimizing cycles after questions

Full guide includes:

Anonymized plots, decision log, final summary page.
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Biopharmaceutical Characterization

Small Molecule & API Analysis

Trace Element & Salt Analysis

Stability & Degradation Studies

Method Development & Validation