Frequently asked questions
At what stage should viral clearance studies be performed?
The timing and scope of viral clearance studies depend on the development stage and regulatory strategy. Studies are typically performed once the relevant downstream process is sufficiently defined to allow representative evaluation of virus removal and inactivation steps. We can support study strategies appropriate to both earlier- and later-stage programs.
What types of viruses are selected for viral clearance studies?
Virus selection is based on factors including the production system, potential viral risks, characteristics of the manufacturing process, and applicable regulatory expectations. We work with clients to establish a scientifically justified virus panel appropriate to the product and study objectives.
Can you reproduce our purification process at small scale?
Yes. Relevant purification steps can be scaled down and assessed under representative process conditions. Pre-study work can be used to establish process and assay suitability before execution of the viral clearance study.
Can you support viral clearance studies as a standalone service?
Yes. Viral clearance studies can be performed as part of an integrated Northway Biotech development and manufacturing program or as a standalone service for processes developed or manufactured elsewhere.
Can you conduct multiple viral clearance studies in parallel?
Yes. Our dedicated infrastructure provides capacity for up to six individual studies to be conducted in parallel, supporting efficient execution of more complex study programs.
Do your viral clearance studies support regulatory submissions?
Our studies are designed with consideration of applicable regulatory expectations, including ICH Q5A(R2), and include controlled study execution, data evaluation, and QA/QC-reviewed reporting to support development and regulatory documentation.
