U.S. Biologics, Advanced Therapies & Medical Devices Manufacturing and Testing

viral clearance

WuXi AppTec offers custom studies to validate removal, inactivation, or cleaning processes for viruses, and we are the clear leader in this field with more than two decades of experience. Our scientific and quality teams have comprehensive expertise in infectivity and quantitative PCR assays, process development, and international regulatory considerations for early- and late-stage products.

Processes Experience

Our experience spans a broad number of different processes including:

INACTIVATION REMOVAL
– Heat / Pasteurization – Column
– Low and High pH – Chromatography
– Solvent / Detergent – Filtration
– Irradiation – CLEANING
– Sterilization – Kinetics of Inactivation
– High-Energy Light – Coupon Studies

Program Features

Studies conducted for R&D, Phase 1-3, BLA, Marketing-Approval and 510K submissions include:

  • Monoclonal antibodies
  • Recombinant proteins
  • Blood-derived products
  • Gene therapy vectors
  • Viral vaccines
  • Tissues (bone, skin, collagen, heart valves)
  • Virus removal/inactivation instruments, technologies, resins, matrices & devices

Database Mining

With over 24 years experience and 3,000 studies conducted at WuXi AppTec, we have assembled a powerful database mining tool to help our clients in their process development efforts. WuXi AppTec can consult on which process steps or process parameters may be ideal or problematic in achieving the desired clearance levels before performing the actual clearance studies. This information could be critical to avoid costly delays, or the inclusion or evaluation of unnecessary process steps.

High-purity, High-titer Virus Stocks

As preparation, purification and use of high-purity, high-titer viral stocks is one of the most critical aspects in the performance of a viral clearance study, WuXi AppTec has set the standard for how these stocks should be made, with refined and proprietary purification techniques. Our ultra-purified stocks help ensure the data generated is the most accurate assessment of your processes’ ability to clear or inactivate virus.