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BSE Expertise

BSE Expertise and TSE Risk Assessments

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BSE Expertise

Navigating the complexities of Biosafety and Bovine Spongiform Encephalopathy (BSE) risk management is essential for any biotech or pharmaceutical company working with animal-derived components. Our BSE Expertise consultancy provides comprehensive support to help you meet regulatory expectations and ensure the safety of your products.

We offer in-depth Evaluation of Biosafety measures and provide expert guidance on the Adventitious Agents section of the Common Technical Document (CTD 3.2.A.2). Our team is well-versed in the Epidemiology of Virus and Prion Risks associated with animal-derived materials, enabling us to deliver thorough TSE Risk Assessments tailored to your specific needs.

Our consultancy specializes in Evaluating Prion Clearance Capacity to verify that your processes effectively mitigate any potential prion risks. Additionally, we assess TSE risks by evaluating the overall impact of prions (e.g., BSE, CJD, or other prion agents) in biopharmaceutical products.

We precisely Review Data form prion clearance studies, testing results, and reports, ensuring the robustness, reliability, and compliance of your safety measures. Additionally, we offer comprehensive Prion Safety Assessments to help you uphold the highest safety standards across your development and manufacturing processes.

With our specialized expertise, we guide you in developing a solid prion safety strategy that aligns with regulatory requirements and enhance your overall product safety profile. Partner with us to ensure your biosafety measures are state-of-the-art and your documentation is inspection ready.

Dr Andy Bailey

Managing Director & CEO

Andy, originally a chemist/biochemist, later specialized in virology during his 9-year tenure at the MRC Virology Unit in Glasgow, Scotland, where he focused on studying Herpesviruses and Adenoviruses. In 1995, he transitioned to the industry, first as Director of Virus Validation Services at Q-One Biotech Ltd, and later as part of the Pathogen Safety group of Baxter Healthcare in Vienna, Austria.

With over 30 years of expertise in virus and prion safety, Andy has presented at numerous regulatory agencies and conferences, supporting product registrations, and contributing as an invited speaker at expert workshops. His experience includes presentations to regulatory bodies to support submissions for various products, including the UK MHRA, German PEI, French AFFSAPS, US FDA, EMEA, and Japan´s PMDA. This deep involvement has given him a comprehensive understanding of regulatory affairs surrounding virus and prion safety.

Additionally, Andy served as an external expert for the EU SCENIHR committee on emerging human health risks, coauthoring an opinion on “The Safety of Human-derived Products with regard to Variant Creutzfeldt-Jakob Disease”. His ongoing contributions as a speaker at international biopharmaceutical conferences further reinforce his expertise and leadership in the field.

In 2005, Andy founded ViruSure, driven by a commitment to delivering reliable, high-quality testing services to the biopharmaceutical industry, a philosophy that remains a key focal point to the company today. This deep-rooted expertise ensures clients receive trusted, scientifically grounded consultancy, making ViruSure a dependable partner for biopharmaceutical safety needs.

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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