Adeno-Associated Virus (AAV) Drug Product Release Testing
IND submission requires drug product release testing. To speed up your timeline, Solvias offers an off-the-shelf package of assays that meet ICH Q5A(R2) guidelines for AAV drug product release testing. With years of experience, we can help you navigate the regulatory environment and support you in specification settings.
- Identity: Viral copy number (TCID50 & genomic PCR), vector payload analysis (GMP-AUC), viral sequence, pH
- Purity: Bioburden, endotoxin, HCP, HC DNA, PEI, residual Benzoase, Aggregates, appearance, osmolarity
- Potency: Extractable volume
Pre-Master Cell Bank (MCB) Clone Characterization
Finding a defect in the clone used to create the MCB can derail the drug development process and have a disastrous financial impact. A final characterization check is an opportunity to do a definitive confirmation before committing to the master cell bank clone.
Although not mandated by the regulatory agencies, this step is an important step in de-risking your development program. Attributes like aberrant glycosylation patterns, vector copy number and general cell health can impact patient safety and cell line growth efficiency. Solvias offers an off-the-shelf characterization package to quickly de-risk your MCB.
- 50 cell profiles by TEM
- Vector copy number by ddPCR
- Genetic characterization by TLA (chromosomal position)
- Protein characterization by LC-MS, AA sequencing, PTM and glycan screen
Characterization of Lipid Nanoparticles (LNPs)
LNPs are a type of nano-scale drug delivery system designed to encapsulate and deliver various therapeutic agents such as small molecules, nucleic acids, gene editing technology (CRISPR), peptides and proteins.
LNPs are composed of natural or synthetic molecules that assemble into lipid bilayers, resembling cell membranes which can improve solubility and bioavailability of the drug. Solvias offers many modalities for LNP characterization.
- Nanoparticle concentration and composition (HPLC-CAD, HPLC-MS)
- Total RNA/DNA (CZE/Affinity CE-F, IP-RP/CGE)
- Free RNA/DNA (GCE-F, CZE-F)
- Size, shape and charge (MALS/DLS, CZE)
- Potency (CB LC-MS, CBBA)
- Encapsulation efficiency (CZE, Cryo EM)
GMP Analytical Ultra Centrifugation (AUC) to Assess Vector Payload
Gain a complete understanding of your vector payload with GMP-AUC. It is more precise and has better resolution than orthogonal technologies.
Only Solvias can offer gold-standard GMP-AUC which will be part of the ICH Q5A guidelines for 2024.
Targeted Locus Amplification (TLA) Technology to Assess Integration
TLA technology uses the physical proximity of nucleotides within a locus of interest as the basis of selection, enabling the targeted complete enrichment and sequencing of any locus.
Transmission Electron Microscopy (TEM) to Assess Cell Health
TEM is a valuable, high-resolution tool in assessing cell health. Healthy cells are needed to maintain a stable, high-density culture and are more robust and resistant to stress.
TEM allows visualization of subcellular changes that could be indicative of stress or damage.
Get in touch to speak with one of our experts.