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Agenda
Our agenda is carefully curated to provide diverse viewpoints, scientific exchange, and a forum to share challenges. We’ll focus on industry trends; share research insights; explore and exchange technologies, strategies, and capabilities; provide training opportunities; and create rich opportunities for learning and connection between people and organizations.
Day 1 - Tuesday, June 10
Registration and Continental Breakfast
Welcome and Opening Comments
Session 1 – Recognizing and Identifying Hazards
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Casey Cosner (Millipore Sigma)
Elements of a Successful Potent Compound Safety Program
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Robert Sussman (SafeBridge Consultants)
Hazard Evaluation and the History of Occupational Exposure Banding
- Identifying the hazardous endpoint
- Other endpoints that determine hazard
- Determining hazards for compounds with limited data
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Michelle Hernandez (Merck)
Hazard Evaluation of New Chemical Entities (Drug Innovator Perspective)
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Joe Galati (ThermoFisher)
On-boarding of New Chemical Entities (Drug Innovator Perspective)
- 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
Break
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AJ Troiano (Fujifilm Diosynth Biotechnologies)
The Rise of Potent Biologically Derived Drug Substances: Shifting Trends in Pharmacodynamics and Pharmacokinetics
- 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.
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Above speakers
Panel Discussion
Lunch
Session 2 – Evaluating Facilities, Equipment, and Risk
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Hari Floura (Floura LLC)
HPAPI Manufacturing: Key Engineering Challenges for Existing Facilities
- 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?
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Rich Arnett (Pharmascience)
Meeting the Needs of Today & Beyond: Important Considerations before Renovating Multi-product Injectable Facilities to Better Handle Highly Potent Compounds
- Clarifying the vision – product considerations & future capabilities
- Identifying the Musts vs the ‘Nice-to-haves’
- Minimizing disruption to the existing business
Break
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Lisa Schubert (Merck)
Assessing Aerosol Migration Pathways from Single-Use Equipment Process Upsets
- 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.
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Above Session Speakers
Panel Discussion – Facility Design
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Ryan Graff, Allan Ader, Robert Sussman
Day 1 Wrap-up
Reception
Day 2 - Wednesday, June 11
Continental Breakfast
Session 3 – Controlling and Managing Exposure
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George Petroka (IES Engineering)
ISPE Containment Guide
- Fundamental considerations and developing a containment strategy
- Primary and secondary containment systems
- Associated elements (occupational hygiene, cleaning, administrative)
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John Roosa (Merck)
Integrating Process Equipment with Exposure Controls
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Speaker TBD (Howorth)
Rigid-wall Isolator Design and Use
Break
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Ashley Harp (CRB)
Applying Soft Wall/Flexible and Hard Wall Isolators for ADC Manufacture
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Michael Maintok (Glatt)
Trends in Containment:
- Room Concepts
- Automation / Robotics
- Continuous processes
Lunch
Session 4 – Verifying Control and Continuous Improvement
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Karen Whitaker (Merck)
ISPE SMEPAC Guideline Version 3 – What’s New?
- 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.
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Brent Altemose (ALTIH)
To Pass or Not to Pass a Containment Performance Assessment – Is that the Question?
- 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
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SafeBridge
Day 2 Wrap-up
Adjourn
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