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Virus Safety

Evaluation of Virus Safety and Regulatory Guidance

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Virus Safety

In the biotech and pharmaceutical industries, maintaining virus safety is paramount to ensure the safety, efficacy, and regulatory compliance of products, especially those derived from biological sources. Our Virus Safety consultancy provides specialized support to help you develop, evaluate, and optimize robust virus safety strategies throughout your manufacturing process.

We offer comprehensive Donor Testing services, which are conducted following risk assessments that consider factors like donor origin and potential virus exposure. Our experts also perform Process Evaluations for Virus Removal to identify and mitigate viral risks, ensuring your production processes are secure and compliant.

For companies advancing into Continuous Manufacturing, we provide Virus Validation services to help verify that your systems effectively control and eliminate viral contaminants. We also specialize in the Evaluation of Virus Clearance Capacity, ensuring that your virus clearance processes are robust and aligned with the latest industry standards.

Our team delivers Expert Reports and thorough Biosafety Evaluations to support your regulatory submissions and internal quality assurance efforts. With our deep understanding of global regulations, we offer tailored Regulatory Guidance to help you navigate the complex landscape of virus safety compliance.

Partner with us to enhance your virus safety protocols, ensuring your products meet the highest standards of quality and safety while achieving successful regulatory approvals.

Katy Lorineau

Scientific Officer

Katy earned her Biotechnology degree from ENSTBB, the National School of Biomolecule Technology in Bordeaux, in 2003. She began her professional career at Oxxon Therapeutics in Oxford, UK, a company focused on therapeutic vaccines and immunotherapy (now part of Oxford Biomedica). During her time there, she developed and validated qPCR assays for the characterization of MVA and FPV viral vector vaccines.
In 2006, Katy joined ViruSure, where she contributed to the GLP studies and quality groups. Starting as a GLP Study Director, she later advanced to GLP Study Manager and eventually took on the role of Head of GLP Validation Studies. In 2024, she was promoted to Scientific Officer, reflecting her broad experience and leadership in the field of GLP studies.
Throughout her career, Katy has been an active participant in international virus and prion safety conferences, and she regularly supports GLP study trainings at ViruSure Workshops. Her extensive knowledge and commitment to advancing safety testing methodologies provide valuable insights to clients, ensuring robust and reliable results in each project.

Publications
  1. EU opinion paper: SCENIHR Opinion on vCJD
  2. Bailey AC (1998). Strategies for the validation of biopharmaceutical processes for the removal of TSE contaminants – Editorial. European Biopharmaceutical Review.
  3. Lovatt A, Black J, Galbraith D, Doherty I, Moran MW, Shepherd AJ, Griffen A, Bailey A, Wilson N and Smith KT (1999). High throughput detection of retrovirus-associated reverse transcriptase using an improved fluorescent product enhanced reverse transcriptase assay and its comparison to conventional methods. Virol. Meth., 82, 185-200.
  4. Bailey AC, Steinthorsdottir V, Rinaldi A and Mautner V (1999). Properties of the adenovirus type 40 E1B promoter that contribute to its low transcriptional activity. Virology, 265, 10-19.
  5. Foster PR, Welch AG, McLean C, Griffin BD, Hardy JC, Bartley A., MacDonald S, and Bailey AC (2000). Removal of abnormal prion protein by plasma fractionation. Transfusion Science, 22, 53-56.
  6. Foster PR, Welch AG, McLean C, Griffin BD, Hardy JC, Bartley A, MacDonald S and Bailey AC (2000). Studies on the removal of Abnormal Prion Protein by Processes Used in the Manufacture of Human Plasma Products. Vox Sanguinis 78, 86-95.
  7. Prowse C and Bailey A (2000) Validation of prion removal by leucocyte-depleting filters: a cautionary tale. Vox Sanguinis, 79, 248.
  8. Morrica A, Nardini C, Falbo A, Bailey AC, Bucci E (2003). Manufacturing process of Anti-thrombin III concentrate: viral safety validation studies and effect of column re-use on viral clearance. Biologicals. 2003 31:165-73.
  9. Bailey A (2003). TSE Cleaning Agents. The Source, Sept 2003.
  10. Bailey A (2006). BSE und Biotech-Produkte: Zukunftsperspektiven für die biopharmazeutische Industrie. Nova Acta Leopoldina; 94, 41-67.
  11. Svae TE, Neisser-Svae A, Bailey A, Reichl H, Biesert L, Schmidt T, Heger A, Römisch J. (2008). Prion safety of transfusion plasma and plasma-derivatives typically used for prophylactic treatment. Transfus Apher Sci. 39:59-67
  12. Neisser-Svae, A. Bailey, L. Gregori, A. Heger, S. Jordan, M. Behizad, H. Reichl, J. Römisch & T.-E. Svae (2009). Prion removal effect of a specific affinity ligand introduced into the manufacturing process of the pharmaceutical quality solvent/detergent (S/D)-treated plasma OctaplasLG®, Journal compilation©, 2009 International Society of Blood Transfusion, Vox Sanguinis; 97: 226-233..
  13. Heger A, Bailey A, Neisser-Svae A, Ertl M, Römisch J, Svae TE. (2012). Removal of prion infectivity by affinity ligand chromatography during OctaplasLG® manufacturing–results from animal bioassay studies. Vox Sanguinis; 102:294-301.
  14. ML Chou, A Bailey, T Avory, J Tanimoto, T Burnouf (2015). Removal of transmissible spongiform encephalopathy prion from large volumes of cell culture media supplemented with fetal bovine serum by using hollow fiber anion-exchange membrane chromatography.  PLoS One. 10: e0122300.
  15. YC Kao, A Bailey, B Samminger, J Tanimoto, T Burnouf (2016). Removal process of prion and parvovirus from human platelet lysates used as clinical-grade supplement for ex vivo cell expansion. Cytotherapy; 18:911-24.

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