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Biosafety Considerations for Handling & Using Novel Biological Agents

Biosafety Considerations for Handling & Using Novel Biological Agents

Biosafety Considerations for Handling & Using Novel Biological Agents

Veterinary Cancer Society
Veterinary Cancer Society
on behalf of Missouri Veterinary Medical Association


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Launch date: 15 Apr 2015
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Last updated: 27 Aug 2018

Reference: 150695

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Biosafety Consideratins for Handling &Y Using Novel Biological Agents With the advent of the Molecular Biology revolution and the exponential growth of knowledge it brought, several new product classes including novel oncolytic, and conditionally replicating viruses, viral vectors, antibodies, cell products/stem cells, dendritic cell vaccines, proteins, peptides, and plasmid DNA vaccines were introduced and continued to be tested in human clinical trials. Owing to their success, some have even become licensed treatments. Recently, due to the ability to quickly sequence changes in a tumor DNA, there has been a movement to create personalized treatments for individuals based upon the genetic changes observed in their cancer. Facility design considerations for the safe and aseptic manufacturing of these diverse biological products are well described. The safe use of these products inside and outside of the hospital or academic setting is also fairly well provided for and includes traditional biosafety concerns including the protection of the person handling the material, the environment, and the public’s health. As these product classes move into the arena of Veterinary care, the same considerations already described for safe use and handling in humans will also apply. These considerations include the selection and use of proper personal protective equipment, containment, disinfection & decontamination after use as well as in the event of a spill, facility design as well as medical surveillance if required. These topics will be discussed and evaluated during this talk.


Goals of this webinar
1 .Identifying the different classes of biological anti-cancer therapeutics you might come across.
2. Understanding what Bio-safety level means and considerations for PPE and handling practices of these agents.
3. A discussion of each product class.
4. A discussion of disinfection versus sterilization and general principles for cleaning spills
Veterinary Cancer Society

Author Information Play Video Bio

Veterinary Cancer Society
on behalf of Missouri Veterinary Medical Association

William P Swaney (Bill) is the Operations Director of the Washington University School of Medicine (WUSM) Biologic Therapy Core Facility (BTCF). The BTCF facilitates the rapid and early translation of promising novel research into clinically relevant interventions intended to treat, prevent, or improve outcomes for cancer and other diseases. Operational since late 2004, the BTCF maintains a cGMP compliant, FDA registered, 2,615 sq ft modern pharmaceutical cleanroom comprised of 6 independent manufacturing suites and is equipped with the necessary validated and calibrated production equipment required to manufacture and use novel viral, cellular, biologic, and radio-labeled products in human clinical trials. The core has a highly trained staff, competent in regulatory compliance and an independent QA coordinator who oversees the facilities quality systems. As the Operations Director, Bill oversees the daily operation of the facility. Bill earned his BS in Molecular & Cellular Biology from Penn State University and his MS degree in Human Genetics from the Graduate School of Public Health at the University of Pittsburgh. He is a Senior biotechnology professional with over 22 years experience in biopharmaceutical manufacturing of novel Biologic, Viral, Cellular, & Radio-labeled proteins for use in clinical trials. He has help leadership roles and operated other specialized pilot manufacturing facilities at the Cincinnati Children’s’ Hospital, Tulane University School of Medicine, and University of Pittsburgh.

Current Accreditations

This course has been certified by or provided by the following Certified Organization/s:

  • Missouri Veterinary Medical Association
  • 1.00 Hours -
    Exam Attempts: 3
    Exam Pass Rate: 60

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