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Inside the Clean Room - Safely Handling Cell & Gene Therapies

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From CAR-T therapies to viral vectors, cell and gene treatments are redefining the boundaries of pharmacy practice—but with innovation comes complexity. Host Carolyn Liptak welcomes Dr. Mark Wiencek, Principal Microbiologist with the Technical Services Group at Contec, and Dr. Amanda Frick, Senior Clinical Manager of Market Intelligence at Vizient, to break down the challenges of compounding these advanced therapies.

 

Listen in as they discuss real-world risk assessments, biosafety considerations, and how hospital pharmacies can safely manage these groundbreaking yet high-risk treatments.

 

Guest speakers: 

Mark Wiencek, PhD

Principal Microbiologist, Technical Services Group

Contec


Amanda Frick, PharmD, BCPS

Senior Clinical Manager, Market Intelligence
Vizient

 

Host: 

Carolyn Liptak, MBA, RPh 

Pharmacy Executive Director 

Vizient

 

Show Notes: 

[01:02-01:51] Mark shares his background and experience in microbiology

[01:52-04:04] Overview of the types of cell and gene therapies (CGT) currently used in clinical practice

[04:05-05:14] Which CGT therapies are most applicable to pharmacy compounding and why

[05:15-10:29] Things not on the NIOSH list and the risks

[10:30-12:03] Evaluating whether viral vectors can penetrate intact skin and the true occupational exposure risks

[12:04-13:18] If hazards are not defined by the NIOSH list, how should these CGT hazards be classified

[13:19-15:03] Determining the safest environment for compounding CGT therapies

[15:04-20:14] Best practices for decontamination, disinfection, and viral vector handling

[20:15-20:59] Do you need a dedicated biosafety cabinet for CGT therapies

[21:00-22:55] Recommended resources for further learning

 

Links | Resources: 

  •  Blind and colleagues (Nationwide): Click here
  • Wang and colleagues (Stanford): Click here
  • CONTEC HEALTHCARE WEBINAR Using Bugs as Drugs: Compounding Viral Vectors in Cell & Gene Therapy for Hospital Pharmacies, Mark Wiencek, May 13, 2025: Click here
  • Blind, J.E., Ghosh, S., Niese, T.D., Gardner, J.C., Stack-Simone, S., Dean, A. and Washam, M., 2024. A comprehensive literature scoping review of infection prevention and control methods for viral-mediated gene therapies. Antimicrobial Stewardship & Healthcare Epidemiology, 4(1), p.e15. Click here
  • Deramoudt, L., Pinturaud, M., Bouquet, P., Goffard, A., Simon, N. and Odou, P., 2024. Method for the detection and quantification of viral contamination during the preparation of gene therapy drugs in a hospital pharmacy. Occupational and Environmental Medicine, 81(12), pp.615-621. Click here
  • Korte, J., Mienert, J., Hennigs, J.K. and Körbelin, J., 2021. Inactivation of adeno-associated viral vectors by oxidant-based disinfectants. Human Gene Therapy, 32(13-14), pp.771-781. Click here (abstract only; full article available for purchase)
  • Martino, J.G., McConnell, K., Greathouse, L., Rosario, B.D. and Jaskowiak, J.M., 2024. Cellular therapy site-preparedness: Inpatient pharmacy implementation at a large academic medical center. Journal of Oncology Pharmacy Practice, 30(8), pp.1442-1449. Click here
  • Penzien, C., 2023. Safe handling of BioSafety drugs and live virus vaccines. Pharm Purch Prod, 20(4), p.12. Click here
  • Petrich, J., Marchese, D., Jenkins, C., Storey, M. and Blind, J., 2020. Gene replacement therapy: a primer for the health-system pharmacist. Journal of Pharmacy Practice, 33(6), pp.846-855. Click here
  • Wang, A., Ngo, Z., Yu, S.J. and MacDonald, E.A., 2025. Implementing standard practices in the safe handling of gene therapy and biohazardous drugs in a health-system setting. American Journal of Health-System Pharmacy, p.zxaf026. Click here

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