Viral Clearance Studies

Download PDF

Download PDF

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

Download PDF

Download PDF

With over 20 years experience and 2000 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 Titer Virus Stocks

As preparation, purification and use of 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. Our ultra-purified stocks help ensure the data generated is the most accurate assessment of your processes’ ability to clear or inactivate virus.

Real-time Quantitative PCR

For processes in which both clearance/removal and inactivation occur, qPCR has become a leading technology in determining clearance and removal, or to complement standard viral titration assays. WuXi AppTec has developed over 15 qPCRs assays to common model viruses used in viral clearance studies.

Additional Services

Cleaning Validations • Resin Cycling Studies • Performance of Process Scale-Down Validations

Viral Clearance Experience

  • Approaching 2000 custom viral clearance studies performed for IND, BLA, and market approvals.
  • Over 30 human and animal viruses available as high-titer stocks.
  • Experience with recombinant proteins, monoclonal antibodies, tissue and plasma products, vaccines, gene therapy vectors, and other product types.
  • Many years of performing testing services based on global regulatory requirements – including FDA, ICH, ISO, CEN, AAMI, HIMA, USP, JMHLW, ANSI, WHO and ASTM – and applicable GLP and GMP guidelines.

Program Features

  • Large-volume testing to improve log reduction claims.
  • Experienced staff can perform entire study for Sponsor including scale-down and resin cycling, or can work with client to execute the study.
  • Regulatory advice and consulting – from executing risk analysis to mining WuXi AppTec’s database of previous study results.
  • Ten fully-equipped suites and over 10 AKTA and AVANT systems available for custom studies, enabling easy scheduling of customer on-site validations.
  • Senior staff study directors and dedicated project managers with experience on hundreds of custom studies.