Viral Clearance

Viral Clearance
Proven Viral Safety You Can Trust
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Minaris Advanced Testing is a global leader in viral clearance testing, having conducted over 3,000 viral clearance studies with zero regulatory rejections. Our deep technical expertise, harmonized quality systems and dedicated testing infrastructure make us the ideal partner for ensuring viral safety in biologics, gene therapies and viral vaccines.

We design and execute viral clearance studies aligned with ICH Q5A(R2), WHO guidelines and FDA/EMA expectations, whether you’re advancing toward IND, IMPD or BLA.

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Viral Clearance Services and Study Design

We tailor viral clearance studies to your process, product class and development phase:

Early Phase Studies
(Phase I/II)

  • Two-virus or three-virus panel, including enveloped and non-enveloped viruses

  • Assessment of product origin and potential contaminants

  • Preliminary toxicity and interference testing

  • Focused approach to reduce timelines while meeting regulatory rigor

Late Phase Studies
(Phase III and BLA)

  • Expanded virus panels: DNA/RNA, large/small, enveloped/non-enveloped

  • Multiple chromatography columns (new and aged media)

  • Virus retentive filtration (VRF), viral inactivation (VI) and orthogonal clearance

  • Mass balance and carryover studies in additional fractions

  • Safety margin evaluation with LRV ≥ 4 for key model viruses

Study Elements:

Virus spiking and clearance validation

Selection of appropriate model viruses

Quantification of log reduction values (LRVs)

Customizable based on product modality and regulatory goals

State-of-the-Art Viral Clearance Labs

Our dedicated viral clearance testing space in our Philadelphia, PA, facility includes:

  • Four private client suites
    Equipped with:

    • 2–3 biosafety cabinets per suite
    • AKTA chromatography systems
    • pH/conductivity meters, analytical balances
    • Nanodrop and UV spec access
  • Client-specific confidentiality protocols
  • Dedicated personnel and conference spaces
  • Option for full or partial transfer of study performance to qualified personnel from Minaris Advanced Therapies

Fit-for-Purpose Design Across Product Types

Our viral clearance testing services support a wide range of modalities:
  • Viral vector gene therapies (AAV, LVV and other applicable platforms)
  • Plasmid DNA and RNA products
  • Recombinant proteins and monoclonal antibodies
  • Gene-edited and stem cell products
  • Viral vaccines
  • Medical devices
  • Viral clearing studies

End-to-End Support for Regulatory Submissions

Our scientific team offers complete study management, from protocol design to submission-ready reporting:

  • Study execution in compliance with applicable GLP requirements
  • Method validation and transfer
  • Data trending and visualization
  • Expert consultation for CMC filing strategy
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Whether you need GMP release testing for a commercial therapy or exploratory analysis for an early-phase asset, we’re here to help. Access our full testing catalogue or submit a sample request today.

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Minaris Advanced Therapies is dedicated to helping innovators in cell and gene therapy succeed. Whether you are in early-stage development or preparing for commercial launch, our end-to-end expertise, global reach and commitment to quality make us the ideal partner for cell and gene therapy manufacturing and GMP biosafety and analytical testing of all biologics.

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