Questions and Answers
What is the primary importance of biosafety?
Protection of personnel, public, and environment in lab settings.
What are considered key components of biosafety in Biopharma? (Select all that apply)
Viral vectors are commonly used for human gene therapy.
True
Viruses used as gene delivery systems are called ________.
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Match the viral vector with its common type:
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What was the percentage breakdown of reported contaminations by host cells?
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Animal-Derived Raw Materials (ADRM) pose a low risk of virus contamination.
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What are the three main risks identified in the Production process?
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Exposure to the environment during open manufacturing steps increases the risk of virus contamination from ___ and the environment.
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Match the risk-mitigation strategies with their descriptions:
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Study Notes
Importance of Biosafety
- Protects personnel working in labs and biological environments
- Protects the general public
- Protects the environment
- Requires direction, resources, and training for safe handling of hazardous biologicals
International and National Biosafety Standards and Regulations
- Laboratory Biosafety Manual (WHO)
- Provides practical guidance on biosafety techniques for labs at all biosafety levels (BSL-1 to BSL-4)
- Covers risk assessment, recombinant DNA technology, and biosecurity concepts
- Laboratory Biosecurity Guidance (WHO)
- Expands on laboratory biosecurity concepts
- Addresses safekeeping of Valuable Biological Materials (VBM)
- Singapore Legislation, Regulation, and Guidelines
- Biological Agents and Toxin Act (BATA)
Role of Biosafety in Biopharma
- Ensures safety during development, production, and distribution of biological drugs and therapies
- Maintains product quality and efficacy by preventing contamination
- Ensures worker safety and environmental protection
Components of Biosafety in Biopharma
- Research and Development: Biosafety measures essential for protecting researchers
- Containment and Control: Different levels of containment (Biosafety Levels, BSL) used based on potential hazards
- Quality Assurance: Biosafety crucial for preventing contamination and maintaining product integrity
- Environmental Responsibility: Preventing the release of genetically modified organisms (GMOs) and hazardous materials
- Public Trust: Commitment to biosafety helps maintain public trust in the biopharmaceutical industry
Safety Terminology in Pharma
- Singapore Biorisk Code of Conduct
Viral Vectors
- Commonly used as gene delivery systems
- Can be used for human gene therapy
- Important safety issue in genetic engineering research
- Examples of viral vectors: Adeno-associated Virus, Adenovirus, Retrovirus, Herpes Virus, Vaccinia Virus
Risk Assessment of Viral Vectors
- Factors to consider: risk group classification, cell tropism, nature of transgene, reversion prevention
- Risk group classification: Based on the relative risk to healthy adult humans
- Cell tropism: Special care necessary when working with pantropic or amphotropic viruses
Case Study of Viral Contamination during Biologics Manufacture
- 26 virus contaminations over the past 36 years
- Most common viral contaminants: Mouse Minute Virus, Reovirus, Vesivirus
- Sources of contamination: Raw materials, manufacturing operators, and cell lines
- Impact of contamination events: Financial costs, manufacturing interruptions, competitive disadvantage, and delays in product development
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Description
This quiz covers the importance of biosafety, protecting personnel and the public, and safe handling of hazardous biologicals in laboratory settings.
