Day Two

Thursday 27th June 2024

8:30 am Morning Coffee & Networking

9:15 am Chair’s Opening Remarks & Recap of Day 1 Learnings

  • Robert Sussman Managing Director, SafeBridge ® Regulatory & Life Sciences Group

Containment & Facility & Process Design to Reduce Cross Contamination & Downtime

9:30 am Round Table: Designing Multi-Modality Suites to Enable Manufacturing Flexibility & Agility

Synopsis

• Refine facility design and equipment procurement strategies to reduce secondary containment requirements

• Evaluate retrofitting decisions and integrating process development with process safety

• Leverage novel technologies to maximize API yield in contained environments

10:30 am Session Reserved for Psarfarma

11:00 am Evaluating the Use of Robotics or Automation to Reduce Operator Exposure to High Potent Molecules

Synopsis

• Considering how robotics may be used in production lines to make manufacturing more time efficient

• Learning what tasks robotics may be implemented for to improve time efficiency of production processes and reduce operator exposure

• Delving into current groups considering the use of robotics in their projects to enhance workflow efficiency

11:30 am Morning Break & Networking

Assessing Regulatory Considerations & Process Re-Development for Quality API Development

12:15 pm Understanding and Categorizing Impurities in Pharmaceutical Products-USP Overview

Synopsis

  • Discussing the USP general chapters regarding residual solvents, elemental impurities, and organic impurities
  • Aligning with FDA guidance and ICH guidelines

12:45 pm Re-Developing Process for A High Potent Molecule with Toxicology Team

Synopsis

• Combining toxicology and process chemistry’s expertise early on: leveraging analytical and characterization techniques to enable early identification of molecule’s potency

• Validating process development and achieving quality by design chemistry and synthesis for a high potent molecule

• Lessons learned in the collaboration and joint efforts between toxicology and process chemistry teams to achieve process optimization, safety and efficiency

Exploring Environmental, Safety & Purity Concerns in Drug Substance & Formulation Production

1:15 pm Networking Lunch

2:15 pm Exploring Containment Monitoring to Assess & Challenge the Containment Capabilities of Equipment & Facilities

Synopsis

• Understanding how to select a suitable surrogate for effective containment monitoring.

• Implementing systems to ensure detection of the surrogate in the facility and to monitor operator exposure.

• Surrogate monitoring case study and handling/facility gap analysis.

2:45 pm Roundtable Discussion: Evaluating the Use of Single-Use, Flexible Containment on the Environment, Sustainability & High Potent Waste

  • Nancy McClellan Global Occupational Hygiene Manager, Occupational Health Management, Inc.

Synopsis

• Establishing the best practices and guidance for reducing the quantity of high potent waste with increasing usage of single-use flexible containment

• Outlining facility design considerations to manage high potent waste to ensure safe storage before removal off-site

• Discussing the implications of using large volumes of wastewater to clean ridged isolators and whether the use of flexible containment will reduce overall waste production

3:30 pm Chair’s Closing Remarks

  • Robert Sussman Managing Director, SafeBridge ® Regulatory & Life Sciences Group

3:45 pm End of Conference