Day Two
Thursday 27th June 2024
8:30 am Morning Coffee & Networking
9:15 am Chair’s Opening Remarks & Recap of Day 1 Learnings
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
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