The use of lipid nanoparticles (LNPs) as non-viral delivery tools for messenger RNA (mRNA) helps alleviate the otherwise poor pharmacokinetics (PK) and in vivo instability of mRNA. However, LNP formulation development and manufacturing remains complex and challenging.

The demand for mRNA-based vaccines and treatments has increased significantly, and the industry has been challenged to not only meet these needs, but also improve existing manufacturing processes and efficiencies.

The use of mRNA for vaccines & therapeutics is being explored due to the advantages that the technology presents, and the promise of mRNA was demonstrated by COVID-19 vaccines, which provided a pathway for future therapeutics to employ this technology.

In this webinar experts cover aspects of clinical trial design for orphan biologics products, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.

In this fireside chat, George Buchman, Ph.D., Vice President, Pre-Clinical and Process Development, Catalent Cell & Gene Therapy and Thomas VanCott, Ph.D., Chief Scientific Officer, Combined Therapeutics, explore how a complete platform approach to fast-track AAVs can enhance quality and efficiency.

Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.

Summary: A single solution integrating development through complete clinical supply to simplify, accelerate and de-risk your monoclonal antibody (mAb) development.

In this webinar, Chemistry Nobel Laureate, Carolyn Bertozzi, Ph.D., Professor, Stanford University, Penelope Drake, Ph.D., Head of R&D, Bioconjugates, Catalent Biologics, and Seema Kantak, Ph.D., Senior Vice President, Biotherapeutics, Exelixis, discuss the latest trends in ADC discovery and development.

Catalent’s Maria Lopez, General Manager of US Cell Therapy discusses the current state of the cell therapy market and the ways Catalent is working to overcome some of these challenges. Based on an interview conducted by, and published in, BioBuzz.

Learn how the right process, clonal HEK293 cell line, and range of off-the-shelf plasmids, along with qualified analytical methods supports a robust supply chain for the development and manufacture of AAV vectors, and the reduction of timelines to clinical evaluation.