SCIE90011: Sustainability and Biosafety
Course Overview and Instructional Team
Subject Code and Title: SCIE90011 – From Lab to Life
Institution: The University of Melbourne, Faculty of Science
Lead Instructors:
Associate Professor Greg Kubik
Dr. Daniel Czech
Dr. Heshan Peiris
Acknowledgement of Country and Legal Notices
Acknowledgement of Traditional Owners:
The University of Melbourne acknowledges the unceded lands of the Wurundjeri Woi-wurrung and Bunurong peoples (Burnley, Fishermans Bend, Parkville, Southbank, and Werribee campuses).
The Yorta Yorta Nation (Dookie and Shepparton campuses).
The Dja Dja Wurrung people (Creswick campus).
The University honors Elders past, present, and future, recognizing a continuous connection to land and water dating back more than years.
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Intended Learning Outcomes (ILOs)
By the end of this lecture, students should be equipped to:
Explain the definition and role of sustainability within the context of biotech and medtech development.
Identify the primary drivers of environmental impact across the entire product life cycle.
Define fundamental biosafety terms, including hazard, risk, containment, and biosecurity.
Outline the framework for a simple biosafety risk assessment tailored for biotech processes or products.
Analyze the trade-offs and synergies between sustainability and biosafety and explain how these factors influence design-level decisions.
The Sustainability Paradigm in Translational Biotech/Medtech
Sustainability is defined as the intersection of three main components (based on the International Union for the Conservation of Nature model):
The Three Pillars:
Environment: Focuses on ecological health.
Society: Focuses on human well-being and social justice.
Economy: Focuses on financial viability.
Intersections of Pillars:
Environment + Society = Bearable: Impacts that humans can endure long-term.
Society + Economy = Equitable: Fair distribution of wealth and resources.
Environment + Economy = Viable: Economically feasible while respecting natural limits.
The Sweet Spot: Sustainable exists at the center where all three overlap.
Application in Biotech/Medtech:
Environmental Responsibility: Managing resource use (materials, energy, water) and controlling emissions/waste throughout the life cycle.
Social Responsibility: Ensuring safety for workers, patients, and communities; emphasizing equity and access (e.g., One Health and low-resource settings).
Economic Viability: Utilizing tools such as Techno-Economic Analysis (TEA), Life Cycle Assessment (LCA), and Social LCA.
Environmental Impact Drivers
Materials and Consumables:
Includes manufacturing necessities such as media, filters, and solvents.
Factors: Origin of material (fossil-based vs. bio-based), recyclability, and geography of sourcing.
Energy:
Total demand categorized by stages: Manufacturing, Distribution, Use, and Disposal/Recycling.
Water:
Involves water demand during manufacturing and use.
Focuses on water toxicity and the impact of disposal.
Waste and Emissions:
Occurs during manufacturing, use, and end-of-life.
Critical factors include the persistence and toxicity of emissions.
Design Strategies for Environmental Sustainability
Avoid / Reduce: Eliminate unnecessary process steps and consumables; minimize energy-intensive unit operations.
Substitute: Implement lower-impact materials (e.g., non-animal media, less hazardous solvents) and prefer cleaner energy sources.
Optimise: Increase yields and process efficiency to reduce the input required per dose or test; minimize rework and batch failures.
Design for End-of-Life: Prioritize recyclability and degradability; select disposal routes that are safe and avoid materials that complicate waste treatment.
Social Responsibility: One-Health and Equity
One-Health: An integrated approach recognizing that human, animal, and environmental health are closely linked. It employs interdisciplinary systems to manage health risks moving across these three domains.
Equity vs. Equality:
Equity: The quality of being fair or impartial. It involves addressing social inequalities so benefits and burdens are distributed fairly, ensuring everyone has access to the resources needed for their specific quality of life.
Equality: The state of being equal or uniform in quantity, degree, value, rank, or ability.
Note: Equity is crucial for creating resilient communities and reducing poverty; it is not the same as simple uniformity (equality).
Biosafety Basics and Definitions
Hazard: The inherent potential of an agent or material to cause harm (e.g., virulence, toxicity, genetic traits).
Risk: The combination of the likelihood of exposure and the severity of the resulting harm.
Biosafety: The protection of people, animals, and the environment from unintentional exposure to biological agents and materials.
Biosecurity: The protection against unauthorized access, misuse, or malicious release of biological agents or materials.
Biorisk Management: The combination of biosafety and biosecurity measures.
Biosafety Domains Across the Lifecycle
R&D and Prototyping: Focuses on pathogen work, GMO construction, viral vectors, and cell lines; involves lab containment and waste management.
Process Development and Manufacturing: Focuses on containment of production strains/intermediates, cleaning/sterilization validation, effluent treatment, and safety compliance.
Use and End-of-Life: Includes safe use of biologics/diagnostics (sharps management), decontamination of single-use consumables, and assessing the environmental safety and toxicity of the final product.
Biosafety in GMOs and Gene-Based Products
Production GMOs Requirements:
Physical and biological containment.
Effective inactivation prior to discharge.
Strict separation of the GMO from the final product.
Continuous monitoring and documentation.
Gene Therapies and Viral Vectors:
Risks include off-target effects, shedding, and long-term consequences.
Requires controlled handling in clinical/manufacturing settings to prevent uncontrolled gene transfer.
Strain Design as a Biosafety Tool:
Reduce inherent hazard by engineering strains with reduced survival outside process conditions.
Implementing auxotrophies or built-in ‘kill switches.’
Engineering to avoid or reduce toxicity.
Sustainability vs. Biosafety: Trade-offs and Synergies
Potential Trade-offs (Single-use vs. Reusable Systems):
Single-use: Offers better biosafety (lower cross-contamination, simpler cleaning validation) but higher environmental impact (increased solid waste).
Reusable: Offers better environmental impact in terms of waste but requires significantly more water, chemicals, and energy for cleaning and complex hygiene protocols.
High Containment vs. Resource Use:
Higher biosafety levels (BSL) increase energy consumption for ventilation and treatment.
Using lower-hazard strains allows for lower containment, thereby reducing energy needs.
Synergies:
Simplified workflows reduce user error (biosafety) and often reduce material/energy consumption (sustainability).
Substituting hazardous materials improves safety for workers/environment and simplifies waste treatment.
Core Principle: Sustainability and biosafety align when we reduce inherent hazards, thereby reducing complexity and waste impacts.
Methods for Embedding Sustainability and Biosafety in Design
Environmental Integration:
Analyze Process Flow Diagrams (PFD) for major material, energy, and waste flows.
Search for opportunities to eliminate steps or solvents.
Biosafety Integration:
Identify biological hazards and potential exposure points.
Verify if containment, inactivation, and disposal are adequate.
Implementation Strategy:
Integrate goals into the User Requirements Specification (URS) (e.g., setting limits on water/energy).
Include metrics in concept screening, Techno-Economic Analysis (TEA), and Life Cycle Assessment (LCA).
Final Goal: Ensure technologies are safe, affordable, and sustainable for the planet throughout their entire life cycle.