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 to:
- monoclonal antibodies
- recombinant proteins
- gene therapy products
- ortho biologics
- tissues, bone, and collagen
- blood products
Texcell produces high-titer, virus stocks for use in our Viral Clearance studies. A diverse virus panel is available that covers a broad spectrum of physiochemical properties and viral classifications. Extra-pure virus stocks are available for use during virus filtration process steps. These stocks are prepared using proprietary purification methods that result in highly purified final virus products having low DNA and protein concentrations.
Considerations when choosing an appropriate virus panel should take into account:
- The risk associated with the product
- Choosing appropriate representative viruses
- Covering a broad spectrum of viral characteristics
A list of viruses available for your Viral Clearance spiking studies can be viewed at the following webpage: https://www.texcell.com/viral-clearance/virus-panel/
Texcell staff has experience executing Viral Clearance studies that evaluate diverse types of chromatography resins and membranes, virus inactivation treatments, and virus filtration processes.
Levels of Service
We offer three levels of service:
For all levels of service, the Sponsor provides buffers, chemicals, packed chromatography resins, and materials for preliminary testing and Viral Clearance studies [with appropriate GLP labeling]. For all levels, Texcell’s team provides the selected virus panel, performs virus spiking of the starting material, and all related assays for quantitation of virus.
Level 1: Classic Service. Sponsor executes the scaled-down manufacturing process at the Texcell laboratory.
Level 2: Collaborative Service. Texcell personnel assist Sponsor in execution of the scaled-down manufacturing process at the Texcell laboratory
Level 3: Complete Service. The scaled-down manufacturing process is tech transferred to Texcell. Texcell personnel execute the entire study at the Texcell laboratory.
Please Contact Us for any Investigational New Drug [IND] or Biologics Licensing Application [BLA] Viral Clearance Study request.