2025 SafeBridge Global Potent Compound Congress & Expo

• Effective Environmental, Health, and Safety (EHS) programs within potent compound-handling settings must embrace a scientific, risk-based philosophy that integrates toxicology, environmental monitoring, engineering, occupational health, shipping/receiving, maintenance and quality.
• A robust program often leans heavily on the industrial hygienist to serve as the liaison between all interested stakeholders.
• Particular attention will be paid to hurdles experienced within the CDMO space.

• Identifying the hazardous endpoint
• Other endpoints that determine hazard
• Determining hazards for compounds with limited data

• Precision medicine revolution and evolution: Where are we?
• What got you here won’t get you there: Novel modality hazard assessments
• Beyond the comfortable: Where do we go from here and how do we get there?

• Enhancing your CDMO occupational toxicology program and improving toxicology data transfer between CDMO and innovator
• Determining health-based exposure limits or default bands for potent compounds and active pharmaceutical ingredients with limited toxicity data, and the evolution during the life-cycle of development, from pre-clinical stage to market
• Partnering with Sales, EHS, Quality, Regulatory, and others, from the quotation stage through to the project being awarded and on-site, to ensure worker safety and patient safety, and to meet client and regulatory expectations for a multi-product facility

• Monoclonal antibodies, fusion proteins, and cell & viral gene therapies are evolving thanks to advances in modern biotechnology.
• Traditional pharmacodynamic and pharmacokinetic paradigms are shifting with longer drug half-lives, immunomodulatory actions, and the ability to target immune-privileged sites.
• Several case studies will be highlighted showcasing market trends from a manufacturing perspective and how we ensure worker and patient safety.

• Determining your project requirements
• Assessing potential program risk
• RFP to CDMO Selection – How to proceed

• Holistic Containment Strategy: Successful containment requires more than engineering controls—it demands integration with a strong containment culture and soft elements such as organizational values, behaviors, and proactive planning.
• Integrated Industrial Hygiene Program: Embedding containment culture and soft elements (e.g., innovative process development, health pre-planning, and change management structures) into the industrial hygiene program, ensures a consistent and effective approach to potent compound safety.
• Sustainable Success Through Soft Elements: Trained staff, robust monitoring tools, budget allocation, data-driven decisions, and clear communication are critical soft elements that reinforce containment efforts and maximize the return on containment investments.

• HVAC: Bridging the gap between best practices and current facility conditions.
• Airlocks: Why do I need it? Which type? How do I implement?
• Engineering Controls: Aren’t PPE and Respirators enough?

• Clarifying the vision – product considerations & future capabilities
• Identifying the Musts vs the ‘Nice-to-haves’
• Minimizing disruption to the existing business

• Ambient and pressurized releases during process upsets from single-use processing trains were evaluated to understand potential exposure and migration pathways.
• The potential for employee exposure from these releases must be carefully considered.
• Positive pressurization schemes used in Grade C and D GMP processing suites can result in aerosolized materials migrating outside of airlocks and suite boundaries when process upsets occur.
• Building ventilation and air handling systems have the potential to become contaminated with aerosolized materials and result in contaminant migration throughout the facility during single-use equipment process upsets.

• Fundamental considerations and developing a containment strategy
• Primary and secondary containment systems
• Associated elements (occupational hygiene, cleaning, administrative)

• Optimized Hood Design for Dust Capture Efficiency
• Ventilation System Integration within your Containment Strategy
• Exhaust system utilities, filtration, and contained dust collector powder discharge

Providing facility, equipment, and process interconnectivity to enable API and ADC capabilities in an efficient, rapid manner.

• Protect people, product, and facilities
• Rapid cost-effective implementation which is “Right First Time”
• Sustainable utilization throughout lifespan of equipment/facility
• Capability spans preclinical, clinical, and manufacturing

• Regulations and Standards
• Concept > Design process
• Ergonomic Verification
• Process Equipment Integration and considerations
• Material Transfer and Layers of Containment
• Containment Performance

• In-depth look at the containment challenges throughout the ADC manufacturing process
• Review potential strategies to help overcome product & personnel risk

• Room Concepts
• Automation / Robotics
• Continuous processes

• Versatile flexible isolator systems for formulation and product development suites
• Multi-function individual isolators create an à la carte containment suite
• Automation additions and functionality enhancements addressed

• ISPE Overview and GPG Purpose: The ISPE (International Society for Pharmaceutical Engineering) provides guidance for the pharmaceutical industry on many topics, and the SMEPAC Good Practice Guide aims to standardize measurement practices for assessing the containment performance of pharmaceutical equipment.
• Key Updates in the 3rd Edition: This edition includes new and updated content on containment performance assessments, sampling strategies, containment equipment test protocols, data analysis and interpretation, and documentation practices to promote effective risk management and compliance.
• Practical Application: The presentation will highlight how the revised SMEPAC GPG is an effective tool for conducting thorough containment performance assessments, focusing on equipment used with potent compounds.

• Best practices for containment performance assessments include the use of statistical tools or decision rules in the analysis of the data, for good reason. Simply “eyeballing” the data compared against a target is often insufficient.
• The pros and cons of several different approaches based on current standards and best practices will be discussed.
• Not all “passing” or “failing” results are equal. Additional factors to consider when either passing or failing will be presented.

• Whether the management of the OH&S program in an organization is done by one or multiple cross-functional teams, integrated solutions on the market today can enable teams to seamlessly access consistent information and encourage greater collaboration, making workplaces safer and more sustainable.
• Learn to build a framework for OH&S maturity, with a proactive emphasis on risk identification and control, and employee engagement by leveraging the ISO45001 framework.
• Illustration of how an integrated approach can / has helped decision makers build their business case for program improvements.