Viral Clearance Process Validation Studies
Viral clearance process validation studies refers to the detection and elimination of viral contaminants, using a wide array of methods, to ensure the product's safety for human use. Over the past few years, viral clearance and viral testing has emerged as one of the key pre-requisites for biopharmaceutical regulatory approvals.
Viral clearance process validation studies have emerged as a mandatory step for regulatory submissions of biologics for commercial applications. These studies result in streamlined manufacturing of contamination free / safe products and on-time delivery of biologics. Owing to this, the demand for these services has increased significantly. It is worth highlighting that, with the continuous revision of the regulatory guidelines, viral clearance and testing studies are already amongst the most essential steps in the manufacturing of biologics, including antibodies, blood products, cell and gene therapies, hormones, recombinant proteins, therapeutic proteins and vaccines.
Our Advantage:
- CNAS Certified Lab
Our lab in China, has been certified by CNAS, our report was recognized by FDA and EU. The indicator virus used comes from the standard conserved strains of ATCC and CVCC. At present, our virus indicator bank includes PRV, VSV, EMCV, PPV, CPV, MVM, Reo3, MuLV, BVDV, Sindbis virus, EV71 virus, influenza virus and other virus strains, providing traceability guarantee for virus detection/inactivation/removal validation research.
- High Efficiency
Based on our rich laboratory equipments and experienced technician, we can ensure the testing can be performed smoothly and quickly, try our best to meet client's new drug developement schedule. During the project execution, we will sync up major milestone and abnormal cases to clients routinely and timely, to make our client keep everything updated.
- Reasonable Cost
We help our clients arrange better test plan based on our experience and knowledge, cut down the testing time to help our client get best ROI
- Full Logistics Services
Biological products are in strict control during import in China custom, and require hard delivery condition, we can provide full logistic services for client's sample import