Viral Clearance Studies
Viral Clearance Studies
Test Articles
We offer services in support of these test articles.
- Download a detailed scope of our Biopharmaceutical Services
Viral Clearance Studies
For all stages throughout the development, manufacturing and release of your biological product, Lancaster Laboratories offers comprehensive, fully cGMP-compliant Viral Clearance Services.
Why Choose Lancaster Laboratories?
- All of our assays are fully validated to meet ICH Q2 requirements.
- We have multiple dedicated clearance suites for extensive capacity and timely execution and reporting of your study results.
- With more than 50 years of collective viral clearance experience, our technical team has vast industry knowledge and experience performing viral clearance studies.
Leadership of Group:
Jeri Ann Boose, Ph.D. - DirectorOver 1 year with Lancaster Laboratories. More than 25 years of industry experience.
Kate Bergmann, Ph.D. – ManagerOver 5 years with Lancaster Laboratories and more than 17 years of viral clearance experience.
Viral Clearance Services
Our scientists design and run viral clearance studies to meet regulatory requirements. Our viral clearance offerings include:
- Variety of validated and well characterized viral stocks to support animal and human-derived products
- Purified virus stocks
- Viral stocks with titers of 107 pfu/ml or greater
- Validated qPCR assays
- Infectivity assays performed real-time
- Large Volume Assays
- Ongoing Regulatory Support Upon Study Completion
Facilities and Equipment
- Multiple HEPA-filtered virus clearance labs
- Multiple AKTA chromatography systems
- Manual chromatography equipment available
- Capacity to accommodate studies with minimal delay
Four Viral Clearance Models
Lancaster Laboratories offers several service models for the performance of viral clearance studies:
- Level 1 – Basic Service: The client provides all materials and down-scale procedures and performs the study in Lancaster Laboratories’ viral clearance suites.
- Level 2 – Enhanced Service: The client provides all materials and down-scale procedures and performs all column chromatography steps. Lancaster Laboratories personnel perform inactivation and virus removal filtration steps.
- Level 3 – Full Service: The client provides all materials and down-scale procedures for transfer to Lancaster Laboratories personnel, who perform all clearance steps.
- Level 4 – Turnkey Service: The client provides a description of the full-scale manufacturing process. Lancaster Laboratories personnel develop and validate the down-scale procedures and perform all clearance steps.
Contact
Request additional information to start working with us today. Or call one of our Business Development Specialists at 717-656-2300.