Synopsis

Innovation and technology are trailblazing the mRNA space, from batch production to automatic and digital design. However, a major challenge in mRNA manufacture is the need to modify existing procedures to effectively scale up the production process to meet global demand, while still complying with regulatory requirements. Join this workshop to discuss the future developments in the mRNA manufacturing industry and uncover the considerations required for scalability:

• Leveraging four decades of innovation from antibody development to ensure future success of mRNA manufacturing
• Overcoming major bottlenecks in continuous manufacturing platform development to boost productivity for mRNA therapeutics and vaccines
• Increasing manufacturing process efficiency through smart and innovative data-driven bioprocessing

Synopsis

Multivalent mRNA-based vaccines have entered clinical development, offering the possibility of one-shot prophylaxis against multiple pathogens or multiple variants of the same parent pathogen. Similar considerations of multivalency or cocktail approaches may apply to mRNA therapeutics as well. However, at present, there is uncertainty surrounding process development, analytical characterization, formulation and lot release strategies for multivalent mRNA drug products (DP). An apparently uncomplicated approach of individually formulating (for example, encapsulating in lipid nanoparticles) each mRNA construct and then combining these formulations to form the final DP. This may have been the approach taken for approved bivalent Covid-19 vaccines and the candidate combination vaccines that are entering clinical trials. Even in these cases, testing individual components for release assays such as dose and potency in the combination DP can be challenging due to non-specificity of some of the conventional test methods. This workshop will facilitate discussions aimed at better understanding and addressing these challenges, and ultimately accelerating development of multivalent mRNA DPs.

• Multivalent mRNA vaccines can offer protection against variant serotypes of the same parent pathogen or multiple diverse pathogens
• Process development, analytical characterization and lot release of multivalent mRNA drug products remain challenging especially when variants are closely related, such as SARS-CoV-2 variants
• In the absence of selective and specific antibodies against each encoded antigen, alternatives to immunoassays need to be developed for multivalent DPs to determine potency, content and functional stability of individual antigens in multivalent drug products
• Opportunities for integrating process analytical technologies into development of mRNA drug substance and formulated drug product manufacturing will be explored

Synopsis

With the boom of the mRNA manufacturing industry and development of large-scale facilities to support the scale-up of mRNA-based COVID-19 vaccines, the industry has seen a surge of investment and opportunity to equitize these processes and miniaturize them into modular units, to advance the future of scale-up capacity at reduced cost. Join this deep-dive workshop to find out how to leverage modular designs, and resources to establish a regional solution to a global problem:

• Revolutionizing cost-effective facility builds with modular manufacturing to reduce development times
• Developing compartment-sized infrastructure, equipment and processes at GMP level for pandemic readiness

Synopsis

For enquiries, please email info@hansonwade.com.