Summary
Discover the cutting-edge world of mRNA-based therapeutics for international markets. Led by industry leaders, this nine-session course is tailored to meet the unique needs and regulatory requirements of the US pharmaceutical landscape.
Explore EU and FDA guidelines, pharmacopeia standards, and facility design specifics crucial for mRNA production worldwide. Gain practical insights into navigating complex regulatory frameworks and optimizing manufacturing processes for success in the US and international market. Specifically, EU guidelines are complex regarding mRNA technology, and they are used also worldwide.
From sterile filling to packaging and transportation, learn the meticulous standards required to ensure product integrity and regulatory compliance. Dive deep into quality control protocols, testing standards, and modern process validation strategies.
Join us to uncover crucial insights on cross-contamination control, supplier qualification, and in-process control strategies, essential for staying ahead in the dynamic world of mRNA manufacturing. Elevate your expertise and accelerate your success in the American pharmaceutical industry with this comprehensive course.
Learning Objectives
- Understanding of regulations and pharmacopeial standards relevant to mRNA-based therapeutics
- Insight into facility design considerations specific to mRNA production, ensuring efficient and compliant manufacturing
- Knowledge of sourcing raw materials and navigating US standards for drug substance and product manufacturing
- Familiarity with sterile filling, packaging, and transportation protocols essential for maintaining product integrity
- Mastery of quality control and testing procedures tailored to meet rigorous regulatory requirements
- Adoption of modern process validation strategies aligned with US regulations to ensure product quality and safety
- Implementation of effective cross-contamination control measures to maintain manufacturing integrity
- Proficiency in supplier qualification methods and material release protocols for mRNA manufacturing
- Understanding of in-process control strategies and sampling techniques crucial for maintaining process consistency and quality assurance
- Awareness of the latest advancements and emerging trends in mRNA therapeutics, empowering attendees to contribute effectively to the rapidly evolving field
Key Topics
- Regulatory Frameworks: FDA and EU guidelines as well as pharmacopeia standards
- Facility Design: Layout considerations for mRNA production
- Manufacturing Processes: Sourcing raw materials and ensuring compliance with international standards
- Sterile Filling and Packaging: Protocols for maintaining product integrity
- Quality Control and Testing: Rigorous standards and analytical methods
- Process Validation Strategies: Modern approaches
- Cross-Contamination Control: Strategies to prevent contamination
- Supplier Qualification: Modern methods for qualifying suppliers
- In-Process Control Strategies: Implementing controls and sampling strategies
Who should attend?
- Professionals involved in the development, production, and regulation of mRNA-based therapeutics
- Scientists and researchers specializing in nucleic acid therapeutics
- Bioprocess engineers and biotechnologists interested in mRNA manufacturing
- Quality assurance and control experts focusing on mRNA product testing and validation
- Regulatory affairs specialists navigating the unique regulatory landscape of mRNA products
- Supply chain managers handling materials and suppliers specific to mRNA production
- Clinical researchers and medical professionals exploring the latest advancements in mRNA therapies
- Investors and entrepreneurs seeking insights into the growing market of mRNA-based medicines
- Educators and students looking to expand their knowledge of cutting-edge biopharmaceutical technologies, particularly mRNA therapeutics
Past Participants
- Senior Engineer, Mrna Process Development Process Development Prime Medicine, USA
- Sr. Director, Recode Therapeutics, USA
- Process Subject Matter Expert, Jacobs, USA
- Engineer II, Technology Transfer, CSL Seqirus, USA
- Research Advisor, Eli Lilly, USA
- Director, Global MS&T, CSL Seqirus, USA
- Research and Operations Associate, Project Manager, ARV Technologies, USA
- Sr Specialist Supplier Quality, Moderna, Switzerland
- Senior Scientist, Novavax, USA
- mRNA Process Development Scientist, Thermofisher Scientific, Italy
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Mastery in mRNA Manufacturing
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
