Accelerating Towards Timely & Harmonious Process Development Decision Making
7:45 am Registration & Morning Coffee
8:45 am Chair’s Opening Remarks
9:00 am Panel Discussion: Assessing the Current State of Play for Highly Potent Development and Manufacturing & Overcoming the “New Normal
Synopsis
- Delving into the key challenges that arise in highly potent development and manufacturing from process design considerations to occupational health
- Understanding where the gaps lie in effective assessment of hazard and how to combat this with effective controls
- Ensuring scale-up occurs in a timely manner
9:45 am Developing a Robust Commercial Manufacturing Process for a High Potency ADC Linker Payload
Synopsis
- Discussing process development for the manufacture of a high potency ADC linker payload
- Reducing high potency compound handling through minimizing isolation points
- Applying statistical design of experimental methodology for the development of a highly robust process for the required 4-step, telescoped final stage of chemistry
10:15 am Containment for the Unknown
Synopsis
- Solutions for pre-clinical process with no toxicology data
- Effective containment development for new processes saving CapEx and accelerating success
- Hard to contain process solved with flexible containment solutions
10:45 am
Morning Break & Speed Networking
Synopsis
Our speed networking is the ideal opportunity to get face-to-face time with many of the brightest minds working in gene therapy and introduce yourself to the attendees that you would like to have more in-depth conversations with. Benchmark against industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond.
Establishing a High-Containment Robust Analytical & Purification Framework to Ensure Drug Product Quality for Patient Safety
11:45 am Developing Crystallization Processes for Highly Potent Compounds
Synopsis
- Revealing work-flow of solid forms screening with highly potent compounds
- Discussing analytical sample handling of highly potent compounds
- Showcasing the benefits and examples of crystallization as a method to purify highly potent compounds
12:15 pm Prep-HPLC Purification at Large Scale Under High Potency Conditions
Synopsis
- Discussing the challenges of large scale prep-HPLC purification under highly potent conditions
- Revealing the safety, quality and operation efficiency bottlenecks
- Focusing on WuXi STA practices
12:45 pm Power of PAT in Data Rich Scale-up & Manufacturing of Highly Potent Drug Substances
Synopsis
- The challenges of high potent drug substances manufacturing
- Examples of PAT tools used in drug substance process development and manufacturing
- PAT Data utilization and management
1:15 pm
Networking Lunch
Addressing Energy & Environmental Concerns with Facility Design & Cleaning
2:15 pm Quantifying the Measurement of Risk in the Cleaning of Pharmaceutical & Medical Devices to Increase Safety & CostEffectiven
Synopsis
- Unravelling ICH Q9 and the ASTM pharmaceutical and medical device cleaning standards
- Clarifying the Cleaning Assurance Level (CAL)
- Revealing how the Shirokizawa Matrix can guide cleaning validation
2:45 pm Revolutionizing Pharmaceutical Manufacturing: Harnessing the Power of Artificial Intelligence & In Silico Tools
Synopsis
- Optimizing the drug discovery process using artificial intelligence to reduce the cost of the development of new therapeutics
- Modelling the behavior of chemical reactions to predict the outcome of different manufacturing conditions to improve product quality and yield
- Monitoring and controlling manufacturing and analytical processes using artificial intelligence and in silico tools to improve efficiency, product quality, and reduce batch rejection
3:00 pm ASTM E55: Clean by Design – The Specification, Design, & Test of Rapidly and Robustly CIP-Cleanable Equipment
Synopsis
- Design for cleanability largely ignored, or with fuzzy specifications historically
- Increased production efficiency and large savings in water and energy attract top management support
- Improved safety for cleaning validation, verification, and maintenance staff in HPAPI facilities
3:30 pm Exploring Cleaning Verification/Validation Requirements While Introducing New Clinical or Commercial Products Into Multi-Product Pharmaceutical/Biopharmaceutical Manufacturing Facilities
Synopsis
- Uncovering the challenges of new product introduction into multiproduct facilities
- Evaluating the new product introduction's impact on the existing cleaning validation/verification program
- Discussing different approaches to identify and reduce risk of cross-contamination due to new product introduction with limited toxicological information
4:00 pm
Afternoon Networking Break
Examining Primary & Secondary Controls for Containment to Pre-Empt Failure & Ensure Process Safety
4:30 pm Panel Discussion: Validating Best Practices for Primary Containment Controls Depending on the Modality to Balance Quality, Practicality & Cost-Effectiveness
Synopsis
- Exploring how different primary controls impact quality, practicality, and cost effectiveness
- How can compromising these accelerate the route to market?
- Uncovering how the modality can influence the importance of different primary controls
5:15 pm What Are Some Hidden Risks About Isolators?
Synopsis
- Potential hazards linked to the handling of hazardous materials within glove boxes and isolators that pharmaceutical and fine chemical entities may overlook
- What are the inherent risks associated with using isolators for hazardous materials, and how do they affect operator safety and product quality?
- How to implement safety protocols that prioritize operator safety and minimize the likelihood of incidents or suboptimal product development when using glove boxes and isolators for hazardous materials?
5:45 pm Uncovering Strategic, Applied Industrial Hygiene Methods to Determine If Isolation Is Required and To What Extent
Synopsis
- Designing an industrial hygiene sampling strategy for small amounts of dense HPAPIs
- Identifying proper statistical analyses to put resources where they are needed
- Protecting people and product at considerable cost savings