Texcell provides GLP-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 Taiwan have executed a combined total of >10,000 viral clearance studies. Texcell’s experienced scientific staff can offer support, guidance, and consultation services for study design, selection of virus panel, and regulatory compliance.
Texcell produces high-titered, fully characterized virus stocks for use in our viral clearance studies. A diverse virus panel is available that covers a broad spectrum of characteristics in terms of resistance to physicochemical treatment and of viral classifications. In addition, extra-pure virus stocks are available specifically 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 level of risk,
- Emerging/novel viruses,
- and the need to cover 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, virus inactivation treatments, and virus filtration processes.
We offer three levels of service:
Level 1 (Classic Service): The client is responsible for the execution of the scaled-down manufacturing process, while Texcell performs the virus spiking studies.
Level 2 (Collaborative Service): Texcell provides experienced staff to assist the client with technical execution of the scaled-down manufacturing process; Texcell also performs the virus spiking studies.
Level 3 (Complete Service): The client transfers their scaled-down manufacturing process technology to Texcell; Texcell also provides experienced staff to execute the scaled-down manufacturing process in addition to performing the virus spiking studies.
Our viral clearance experience includes performing studies to evaluate the following types of biologics: Monoclonal Antibodies (mAb), Recombinant Proteins, Antibody Drug Conjugates (ADC), Vaccines, Blood-derived Products, Medical Devices, Nanoparticles, Gene Therapy Products, ATMPs, and Novel Therapies.