Analytical support for viral vectors

Lot Release, In-Process & Characterization:

• Vector genome copy titer (PCR)
• Infectious titer (TCID50)
• Replication-Competent virus testing
• Capsid Titer (ELISA)
• Total protein (BCA)
• Integrity (gel electrophoresis)
• pH, Osmolality, Conductivity
• Appearance

Stability Program and Testing

• Stability study design and execution

Raw Material Testing

• Identity and purity of media and reagents
• Extractables and leachables

Lot Release, In-Process & Characterization:

• Infectious titer (PCR, Flow Cytometry)
• Vector copy number (qPCR)
• Physical titer (p24 ELISA)
• p24 ELISA
• Integrity (gel electrophoresis)
• pH, Osmolality, Conductivity
• Appearance

Stability Program and Testing:

• Stability study design and execution

Raw Material Testing:

• Identity and purity of media and reagents
• Extractables and leachables

Analytical testing defines the safety, quality, and performance of viral vectors. Robust analytical methods enable accurate characterization of critical quality attributes such as potency, purity, and identity, supporting process development, batch release, and regulatory submissions.

Viral vector analytics include assays for vector genome titer (qPCR/ddPCR), infectious titer, capsid or protein quantification (ELISA), and purity or integrity assessments. Additional methods support stability testing, raw material evaluation, and in-process monitoring to ensure consistent product quality.

Analytical methods are developed to be phase-appropriate and product-specific, then transferred, qualified, and validated in alignment with regulatory expectations. This ensures methods are robust, reproducible, and suitable for supporting IND through commercial manufacturing.

Analytical data form the foundation of CMC sections in regulatory filings. Well-characterized methods and consistent data generation support IND, IMPD, BLA, and MAA submissions, helping demonstrate product safety, quality, and comparability across development stages.