8:00 am Check-In & Light Breakfast
8:55 am Chair’s Opening Remarks
Innovating Containment Strategies to Eliminate the Potential for Cross-Contamination
9:00 am Mastering the Art of Containment: Limiting Exposure with Lyoprotect Bags in Early-Stage Development
Synopsis
- Conducting a surrogate study on Lyoprotect bags to control exposure of high volumes of powder during lyophilization
- Understanding risks of exposure or cross-contamination from open transfer systems to further advance the usage of Lyoprotect bags in early-stage R&D for better accessibility and safety
- Combining various containment devices within a lab to monitor all processes at once for a risk-free environment
9:30 am HPAPI Handling: Navigating Challenges with Containment & Equipment Cleaning for GMP Compliance
Synopsis
- Overseeing quality assurance systems of plants and facilities to ensure GMP compliance in an evolving regulatory environment
- Preventing cross-contamination in shared facilities to protect workers from handling compounds in OEB4 and beyond
- Cleaning of equipment in the manufacturing of HPAPIs to excel in the launch of new shared facilities
10:00 am Session Reserved for Dec Group
Synopsis
Details TBC
10:30 am Morning Refreshments & Speed Networking
Synopsis
A prime chance to make the most of in-person networking and forge new connections with a transformative landscape of companies entering, or expanding their presence within, the highly potent drug manufacturing space. Designed to maximize your introduction to numerous new individuals and serve as a catalyst for ongoing discussions during the 14th premier gathering.
Cracking the Chemistry of Cytotoxic Compounds to Refine Our Process Development Techniques
11:30 am Innovations in Route Design: Revealing the Foundations of Successful Chemical Development of APIs
Synopsis
- Strategizing for the optimal route design in process chemistry to avoid multiple highly potent steps
- Implementing tailored assessments to guide the process development decision-making for designing a new route
- Working alongside the toxicology team to identify all possibilities of high potency for a holistic understanding of different handling requirements
12:00 pm From Lab Bench to Pilot Plant: Perfecting Our Understanding of Small Molecule Engineering
Synopsis
Details TBC
12:30 pm Lunch & Networking
1:30 pm Beyond the Lysosome: Revolutionizing Cytoplasmic-Targeted Drug Conjugates for Manufacturing Precision Therapeutics
Synopsis
- Designing phospholipid drug conjugates for the purpose of cytoplasmic release to combat chemical complexities
- Moving beyond linker chemistries of cathepsin-based release profiles to leverage enzymes present only in the cytoplasm
- Varying linker chemistries to demonstrate a wide range of potent activities from the same drug payload
2:00 pm Panel Discussion: The Crossroads of Science, Compliance & Process Development in Highly Potent Drug Manufacturing
Synopsis
As the pharmaceutical industry is increasingly shifting towards ADCs and high potency small molecules, the complexity of chemistry, manufacturing, and controls (CMC) grows exponentially as we find more unique challenges with developing and scaling these compounds efficiently.
In this dynamic 45-minute panel discussion, we will dive deep into the intricacies of balancing cutting-edge science and rigorous process development with the ever-evolving landscape of regulatory compliance:
- Exploring cutting-edge innovations in process chemistry, formulation, and drug substance development that drive efficacy of highly potent compounds
- Addressing significant challenges in transferring lab-scale processes for large-scale manufacturing to ensure both product quality and operator safety
- Navigating quality concerns that are unique to high potency drugs to control critical process parameters and prevent cross-contamination of products and batches
2:45 pm Session Reserved for Olon
Synopsis
Details TBC
2:55 pm Afternoon Refreshments & Networking
Elevating Our Facility Design to Reinforce Manufacturing Adaptability & Safety for GMP Compliance
3:55 pm High Potency Compounds & Dedicated Manufacturing: A Deep-Dive into Beta Lactams
Synopsis
- Delving into the regulatory history of beta lactams and their requirements for dedicated facilities
- The FDA’s non-penicillin beta lactam drugs: Dissecting the cGMP framework for preventing cross-contamination
- Shedding light on the inclusion of Ezetimibe in the FDA’s draft beta lactam guidance
4:25 pm Mitigating Risks with Highly Agile Facilities: Enhanced Facility Designs for GMP Compliance, Operational Control & Product Management
Synopsis
- Introducing facility designs with a wide variety of options for operating, separating, segregating, and isolating manufacturing operations
- Designing facilities capable of providing flexible areas for different manufacturing stages with clear zoning to separate manufacturing with high to lower risks
- Ensuring manufacturing operations comply with regulatory guidelines such as GMP and relevant occupational health and safety standards under operational and product development challenges