ICH Q14 — Analytical procedure development
Science- and risk-based development, robustness, analytical control strategies and lifecycle thinking; applicability depends on intended use.
Read the original sourceScientific references
The principles
behind the methods.
Selected primary scientific and regulatory sources that inform the analytical topics described on this website.
Guidelines support scientific reasoning; their applicability depends on the product and intended use. Research findings must be interpreted within the conditions studied. These sources do not certify, accredit or endorse Genometrion.
Reference review: 31 October 2026.
ICH Q2(R2) — Validation of analytical procedures
Validation characteristics and evidence appropriate to the intended purpose of an analytical procedure.
Read the original sourceFDA — CMC information for human gene therapy INDs
Product identity, quality, purity and strength, including potency, in the context of gene therapy development.
Read the original sourceGeraerts et al. — Comparison of lentiviral vector titration methods
Primary study distinguishing RNA equivalents, p24 measurements and transducing activity.
Read the original sourceNIST — Gene Delivery Systems
Measurement science for gene delivery, including viral titers and cellular vector copy number.
Read the original sourceMcColl-Carboni et al. — AAV capsid, genome and function characterization
Primary study illustrating the value of orthogonal measurements; findings are specific to the constructs and methods studied.
Read the original sourceCheng et al. — Selective organ targeting nanoparticles
Primary experimental study of composition-dependent RNA delivery and function. Animal results do not establish human targeting.
Read the original sourcePrimary study — LNP delivery across cell subtypes
Separate assessment of nucleic-acid biodistribution and functional mRNA delivery.
Read the original sourceICH Q5A(R2) — Viral safety evaluation
Intended-use considerations for viral-safety methods, including NGS. Scope and suitability must be assessed for each product.
Read the original sourcedMIQE2020 — Digital PCR reporting guidelines
Experimental design, controls, partition statistics, reporting and uncertainty in digital PCR.
Read the original sourceMIQE 2.0 — qPCR reporting guidelines (2025)
Current reporting recommendations for sample handling, qPCR design, reverse transcription, controls and analysis.
Read the original source