WEST JEFFERSON, Ohio, July 30, 2024 (Newswire.com)
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AmplifyBio, an emerging leader among mRNA discovery, development, and manufacturing service providers, announced today that it has formalized a partnership with Stephen Burgess, Ph.D. (AvaBurg LLC), to provide expertise in LNP formulations to ensure efficient encapsulation, protection, and delivery of mRNA to cells.
Dr. Burgess formerly served as Chief Scientific Officer at Avanti Polar Lipids. With 33 years of experience developing new lipids, he is one of the industry’s leading lipid chemistry and membrane dynamics experts. In addition to collaborating with AmplifyBio and their clients on custom lipid formulation, encapsulation, and payload optimization, Stephen will also provide guidance on available lipid delivery systems, lipid manufacturing, stability and storage considerations, regulatory compliance, and documentation compliance.
The choice and design of lipid components are vital for ensuring stability, biocompatibility, and efficient delivery of mRNA therapeutics when using lipid nanoparticles (LNPs). True expertise in the biophysical properties of lipids allows developers to enhance their drug candidates’ efficacy, safety, and scalability.
“With the development of any advanced therapy, it’s so important to have a deep expertise that represents the most up-to-date scientific understanding of the components of these complex medicines,” said Victoria Best, Sr. Director of Scientific Strategy and Innovation at AmplifyBio. “Stephen has devoted his entire career and academic life to developing optimized lipid-based technologies for challenging applications. Having AvaBurg LLC as a resource means that AmplifyBio and our clients can leverage leading expertise for an easily underestimated element of mRNA drug development.”
“Lipid nanoparticles are one of the safest delivery systems for nucleic acid-based drug products; however, significant challenges remain to optimize delivery performance and improve safety profiles. The team at AmplifyBio understands the criticality of the LNP to the overall success of a project and is committed to providing world-class service for their clients. Because of their commitment to excellence, I am excited to work with the AmplifyBio Team to provide solutions to real-world problems for their clients,” said Stephen W. Burgess, Ph.D. President AvaBurg LLC.
The announcement from AmplifyBio follows the company’s announcement in April of a partnership with RNAV8 Bio, a provider specializing in early R&D and sequence optimization of mRNA drug candidates. For its part, AmplifyBio is steadily increasing capacity for high-throughput research-use-only (RUO) mRNA manufacturing and GMP clinical-stage mRNA manufacturing at its flagship Manufacturing Enablement Center in New Albany, Ohio.
About AmplifyBio
AmplifyBio is a contract research and manufacturing organization founded on the principle that all development and scale-up of advanced modality drugs should be done with commercial goals in mind. It was launched out of Battelle in 2021, with an initial offering of industry-leading preclinical toxicology, safety, and pharmacology testing in an agile environment with analytics capabilities that serve the dynamic safety requirements of modern modalities. Since then, AmplifyBio has developed drug characterization and optimization service capabilities and expertise based on the closely held principle that rich characterization, optimization, and data integrity are the keys to reproducibility and scale-up. The company then added GMP manufacturing, completing its concept-to-commercial service offering for the development of advanced therapies.
Source: AmplifyBio
