Integrated analytical development, method assessment, method transfer, QC release testing, and stability study support for plasmid DNA, RNA drug substance, and LNP / targeted LNP drug product programs.
Methods are developed, assessed, transferred, validated, and executed under a connected AD/QC workflow, reducing gaps between process development, GMP readiness, and QC release.
Analytical readouts support feasibility studies, process development, GMP readiness, release testing, stability study, comparability, troubleshooting, and IND-enabling documentation.
AD & QC services can also be commissioned as standalone work packages, including analytical testing, method development, method transfer, method validation, stability study, release support, and assay troubleshooting.
Discuss AD / QC NeedsCATUG supports phase-appropriate analytical method coverage for nucleic acid therapeutics and LNP drug product programs, from identity and impurity control to release testing, stability and comparability.
pDNA / lDNA Analytics
Analytical support for plasmid DNA covers identity, topology, concentration, purity, host-cell impurities, residuals, endotoxin, bioburden, and related quality attributes.
RNA DS Analytics
Analytical development and QC support for RNA drug substance can include identity, concentration, purity, integrity, capping efficiency, poly(A) / tailing, dsRNA, residual DNA, residual NTPs, and in vitro activity.
LNP DP Analytics
Characterization and release testing support for RNA-LNP drug product includes particle size, PDI, zeta potential, encapsulation efficiency, RNA content, lipid content, impurities, potency, sterility, and stability.
Analytical coverage is selected based on payload type, process maturity, formulation strategy, GMP readiness, release requirements and documentation needs.
Discuss Method CoverageCATUG supports analytical method development, client method assessment, method transfer, validation or qualification, and QC execution for nucleic acid drug substance and LNP drug product programs.
Existing client methods can be reviewed for sample compatibility, matrix effects, equipment fit, sensitivity, robustness, GMP readiness and QC execution feasibility.
Product-specific analytical methods are developed or adapted based on sequence, structure, formulation, particle attributes, impurity profile and intended use.
Methods are transferred, qualified or validated according to stage-appropriate requirements, supporting GMP batch testing, release and documentation.
CATUG can help evaluate method readiness, define transfer scope, troubleshoot assay performance, and prepare methods for GMP QC execution.
Discuss Method NeedsCATUG supports QC release testing, CoA generation, stability study design, stability-indicating readouts and analytical documentation for plasmid DNA, RNA drug substance, LNP drug product and sterile DP programs.
QC release testing can be configured for identity, purity, potency-related attributes, residuals, microbiological safety, particle attributes, encapsulation and formulation-specific quality requirements.
Stability study support includes protocol design, timepoint testing, storage condition assessment, freeze-thaw evaluation, lyophilization-related evaluation and stability summary preparation.
CATUG supports CoA preparation, batch testing summaries, analytical review, release documentation and client-facing quality communication for GMP and non-GMP project needs.
Clients may engage CATUG for full QC release packages, selected analytical tests, stability study execution, CoA support, assay troubleshooting or analytical comparability work even when manufacturing is performed elsewhere.
Discuss QC / Stability Needs