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Analytical Method Development and Validation

ICH Q2(R2) LC-MS / MALDI HPLC / CE / IEX GC / ICP-MS GLP / cGMP aligned ISO 9001 / ISO13485 support
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Overview At a Glance Assays Lifecycle Validation Matrix Transfer Requirements FAQ Contact

Overview

Bio-Synthesis provides end-to-end oligonucleotide analytical method support from scouting and optimization to client method transfer, verification and full ICH Q2(R2) validation. Development can be configured for RUO, GLP, diagnostic, release QC, stability or cGMP-oriented programs.

Scouting, optimization, transfer, verification and ICH Q2(R2) validation for DNA and RNA oligonucleotide identity, purity, impurity, residual, elemental and general attribute assays.

Assays can cover identity by LC-MS or MALDI, purity and impurities by HPLC, CE or IEX, residual solvents by GC, elemental impurities by ICP-MS and general attributes such as Karl Fischer water, pH, osmolality and optional sodium content trending.

Final validation scope should be aligned to the oligo modality, method purpose, intended use, risk level and documentation expectations.

Analytical Scope

Method Coverage

A compact view of the assay categories Bio-Synthesis can scout, optimize, transfer or validate.

Identity

LC-MS, MALDI-TOF, optional enzymatic mapping and LC-MS/MS sequence mapping.

Purity & Impurities

RP-HPLC, IP-RP-HPLC, CE and IEX for shortmers, n-1/n-2 species and charge variants.

Residuals & Elements

GC residual solvents, ICP-MS elemental impurities and optional sodium trending.

General Attributes

Karl Fischer water, pH, appearance, osmolality, endotoxin or bioburden when required.

Method Development at a Glance

Quick View

A practical view of lifecycle, validation characteristics and documentation outputs.

01

Lifecycle-Based Support

Scouting → optimization → transfer/verification → validation.

02

ICH Q2(R2) Validation

Accuracy, precision, specificity, linearity/range, LoD/LoQ and robustness.

03

Release & Stability Ready

Methods can support batch release, impurity trending or stability-indicating workflows.

04

Audit-Ready Documentation

Protocols, raw data, calculations, chromatograms, spectra and validation reports.

Assay Capabilities

Assay Category Primary Methods Development Purpose
Identity LC-MS (ESI), MALDI-TOF, optional enzymatic digest mapping, LC-MS/MS mapping Confirm intact mass and support sequence-level confirmation when required.
Purity / Impurities RP-HPLC, IP-RP-HPLC, CE, IEX for charge variants Track full-length product, shortmers, n-1/n-2, depurination and conjugate loss.
Residuals GC for residual solvents and volatile impurities Measure residual solvent profile and support release or process-control specifications.
Elemental Impurities ICP-MS for metals and elemental impurities Evaluate elemental impurity risk and align testing with intended-use requirements.
General Attributes Karl Fischer, pH, appearance, osmolality, optional sodium by IC or flame photometry Support formulation, release, stability and general characterization requirements.
Microbial / Safety Endotoxin, bioburden and related assays when required Add safety-related testing for regulated, sterile, aseptic or high-risk programs.

Method Lifecycle

A phased method lifecycle helps keep early scouting decisions connected to validation readiness and downstream transfer.

Scouting

Column & Condition Screens

Evaluate column chemistry, mobile phase, detection mode, gradient, temperature and sample preparation windows.

Optimization

Resolution & Robustness

Improve peak shape, impurity resolution, carryover control, specificity and stress-challenge behavior.

Transfer

Verification Readiness

Support client method transfer, system suitability, analyst checks and equipment or instrument readiness.

Validation

ICH Q2(R2) Package

Prepare protocol, execute required runs and summarize acceptance criteria, raw data and validation conclusions.

Validation Characteristics Matrix

The matrix is the strongest part of the live page, so it stays prominent. Final requirements are selected per assay, purpose and intended use.

Characteristic Identity
(LC-MS)		 Purity
(HPLC / CE / IEX)		 Residuals
(GC)		 Elemental
(ICP-MS)		 KF / pH / Sodium
Specificity / Selectivity ✓ ✓ ✓ ✓ ✓
Accuracy — ✓ ✓ ✓ ✓
Precision (Repeatability / Intermediate) ✓ ✓ ✓ ✓ ✓
Linearity & Range — ✓ ✓ ✓ ✓
LoD / LoQ — ✓ ✓ ✓ —
Robustness ✓ ✓ ✓ ✓ ✓
System Suitability ✓ ✓ ✓ ✓ ✓

Note: “KF / pH / Sodium” covers general attributes including Karl Fischer water, pH and optional sodium content trending. Final validation elements are defined by the protocol.

Method Transfer, Change Control & Documentation

This section replaces multiple small cards with two balanced panels: one for transfer controls and one for deliverables.

Transfer & Verification

Method Transfer Controls

  • Client method transfer with verification and readiness checks
  • Instrument qualification references and maintenance logs
  • System suitability, analyst training and equipment checks
  • Change control including method versions, deviations and CAPA when applicable
Documentation

Validation Deliverables

  • Protocols and validation plans with acceptance criteria
  • Method versions, change logs, deviations and CAPA documentation
  • Raw and processed data, chromatograms, spectra and calculations
  • Summary validation report and transfer or verification report

Sample Requirements & Instrumentation

Keep sample expectations and instrumentation clear so technical users can quickly determine whether their project is ready for method work.

Sample Requirements

  • Typical development: ≥300–500 µg per method iteration, assay dependent
  • Validation: additional aliquots for accuracy, precision and robustness runs
  • Dry or buffered format; include length, chemistry, purification and concentration
  • Shipping: ambient for DNA; cold chain recommended for RNA or ASO samples

Instrumentation

  • HPLC / UPLC with UV, fluorescence or MS-compatible workflows
  • CE and IEX for orthogonal purity and charge-variant assessment
  • LC-MS, MALDI and LC-MS/MS for intact mass or mapping
  • GC, ICP-MS, KF titration, pH, osmolality and sodium methods

Frequently Asked Questions

FAQ

Which assays can you develop and validate?
Identity, purity and impurity, residual solvent, elemental impurity, Karl Fischer water, pH, osmolality and optional sodium content trending assays.
How do you structure a validation?
Bio-Synthesis finalizes a protocol with acceptance criteria, then executes accuracy, precision, specificity, linearity and range, LoD/LoQ, robustness and system-suitability runs as required.
Do you support method transfer from my lab?
Yes. We perform transfer with verification, instrument suitability checks, and documentation, then proceed to validation if requested.
What sample amount is required?
Development typically needs ≥300–500 µg per method iteration. Validation requires additional aliquots for accuracy, precision and robustness runs.
Can the method support release QC?
 Yes. Methods can be developed for batch release, impurity trending, stability studies or transfer-ready quality workflows depending on intended use.
What deliverables are included?
 Deliverables may include protocols, validation plans, method versions, change logs, raw data, chromatograms, spectra, calculations and summary reports.
More FAQ'sAll FAQ's
METHOD DEVELOPMENT SUPPORT

Need to Develop, Transfer, or Validate an Oligo Method?

Discuss your assay type, oligo chemistry, intended use, target specifications, validation needs or existing draft method with our analytical team. We can recommend a phased plan with documentation deliverables.
Discuss Your Method Request Validation Plan

Need help before quoting?

Email: info@biosyn.com
Phone: 800-227-0627 (US/CAN)
Phone: +001-972-420-8505 (INT)

Related Services

Connect method development with release QC, stability studies, process development and oligo synthesis.

Release QC Stability Studies Process Development Oligo Synthesis

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