Viral Clearance studies are critical in ensuring biological product safety. Texcell offers diverse options for quality data for regulatory submissions.
Investigational Viral Clearance Studies
We define investigational Viral Clearance studies as For Information Only or “FIO”, and tailor them to be quick, cost conscious, and give the most critical information needed to design a robust GLP Viral Clearance.
Texcell’s study directors and scientists have years of experience in purification process development, viral clearance studies, and have played a role in countless FDA, EMA, and other regulatory strategies and submissions for clinical and commercial applications.
Texcell can provide guidance/ideas for:
- Maximizing effective Viral Clearance from your manufacturing platform
- Performing risk assessments for Viral Clearance performance in advance of parameter setting for process validation
- Collaborating on experiment planning to get the most from FIO studies
- Designing Viral Clearance studies for early and late phase regulatory submissions
- Preparing virus safety assessments for your regulatory submission documents
- Being an extension of your process development team in meetings with your CMC project team or your CMC regulatory team
- Designing Viral Clearance experiments for novel manufacturing processes
GLP/GMP-compliant Viral Clearance Services
Texcell provides GLP/GMP-compliant Viral Clearance services in accordance with EMA and FDA regulations. Good Laboratory Practice (GLP) regulations (FDA 21 CFR Part 58) specifically address the requirements for Viral Clearance testing, whereas Good Manufacturing Practice (GMP) regulations (FDA 21 CFR Parts 210 and 211) are specific to manufacturing. In response to industry trends and periodic Sponsor requests, Texcell has elected to incorporate certain quality elements mandated by GMP regulations into the context of Viral Clearance.
Since 1987, Texcell organizations located in the USA, Europe, and Asia have executed a combined total of >10,000 Viral Clearance studies. Texcell’s experienced scientific staff can offer support, guidance, and consultation services for Viral Clearance study design, selection of virus panel, and regulatory compliance.
The Viral Clearance products experience includes, but is not limited too;
- monoclonal antibodies
- recombinant proteins
- gene therapy products
- ortho biologics
- tissues, bone, and collagen
- blood products