In today’s biopharmaceutical landscape, ensuring viral safety is fundamental to building trust in biologics. At Bora Biologics, our Purification Process Development team leads the design and execution of viral clearance strategies that are both scientifically sound and aligned with regulatory expectations.

While we utilize CRO laboratory facilities for virus handling and spiking under appropriate biosafety conditions, our team is directly responsible for preparing columns and buffers, and executing chromatography operations, including low pH treatment and virus filtration, to generate representative material within those labs. This hybrid model allows us to maintain technical ownership of the process while ensuring safety, control, and regulatory compliance throughout the study.

Our viral clearance strategy is grounded in ICH Q5A(R2) and incorporates well-established virus removal and inactivation steps such as:

• Anion exchange chromatography
• Low pH treatment
• Virus filtration

Each study is customized based on the molecule’s characteristics and process design, with careful consideration of operating conditions, spike recovery, and scalability. We work closely with internal stakeholders and CRO partners to design protocols, execute studies, and analyze results with scientific rigor.

Our approach consistently delivers:

• Robust and reproducible log reduction values (LRVs)
• Submission-ready data packages
• Confidence in both product safety and process performance

To date, all CDMO viral clearance projects have been successful, enabling our clients to achieve IND approvals without issue.

At Bora Biologics, viral clearance is not just a regulatory requirement—it’s a vital part of our downstream development philosophy and a reflection of our commitment to quality, science, and patient safety.

About the Author
Lynn Hsiao is a Lead Scientist at Bora Biologics, bringing over 10 years of experience in protein purification and CMC development. Since joining the company in 2013, Lynn has built an extensive track record in purification process development, viral clearance studies, and technical transfer from R&D to CDMO settings. Having managed more than 10 purification projects, Lynn has successfully delivered Phase I clinical materials and supported numerous regulatory submissions. Her expertise encompasses chromatographic operations, process optimization, and interdepartmental collaboration, along with a strong ability to coordinate CRO partnerships for viral clearance. Lynn holds a Master’s degree and is a certified Project Management Professional (PMP), equipping her with the skills to drive projects effectively and ensure quality outcomes in the biopharmaceutical sector.