Assay Development and Validation

Lonza Viral offers a full range of product characterization and release testing for viral vectors and viral vaccines. Our QC team has experience developing and validating a variety of assay types such as, virus infectious titer assays and product specific potency assays.

Stability Testing and Product Storage

A complete understanding of product stability is critical. Lonza Viral can design and perform ICH-compliant stability studies to monitor product integrity over time and/or at multiple storage conditions.

The storage conditions offered include:

  • Liquid nitrogen, vapor phase
  • -70°C ± 10°C
  • -20°C ± 5°C
  • 5°C ± 3°C
  • 25°C ± 2°C with 60% RH ± 5% RH

Click here for a virtual tour of our Houston, Texas facility. 

Quality Assurance and Regulatory Support

The Lonza Viral team offers industry-leading experience for adenoviral vector products from IND to BLA. We are partnered with companies developing product for two Phase III clinical trials as well as a consistency series for US and European regulatory filings. Few service providers have the late stage product development experience offered by the Lonza Viral team. The Lonza Viral team has produced over 60 batches for worldwide clinical trials including product for two Phase III clinical trials. We understand the complexities and the high level of scrutiny associated with viral-based therapy products.

Our expertise in regulatory submissions include:

  • INDs
  • CMC-related filings
  • BLAs

Please note that our clients may also reference Lonza Houston's Type V DMF in their regulatory submissions to the US FDA.

For further questions on our Analytical Services, please email us at viraltherapy@lonza.com