Self-amplifying RNA (saRNA) is a linear and single standard RNA delivery system that can deliver highly immunogenic viral genes and viral peptides to attain rapid and sustained immune response. The saRNA constructs that have been used for gene delivery or vaccine applications have been historically derived from alphaviruses.
Drug developers need to get Phase 1 formulation development right. Without consistent Phase 1 materials, biopharma companies cannot gather reliable data that supports informed decisions about their drug candidates.
Extractables and leachables (E&L) represent an important class of impurities in pharmaceutical products that can arise from interactions between drug formulations and packaging materials, manufacturing components, or delivery devices, and migrate into drug products during manufacturing, storage, or administration.
Biocatalysis is a central pillar of modern organic synthesis. Using enzymes or whole cells as catalysts, researchers deploy biocatalysis to synthesize molecules in mild, environmentally-friendly conditions with high selectivity.
Starting from a previously validated molecule is one of the fastest ways to reach the clinic, but the IP economics are unforgiving. Molecules that closely track prior art offer weak IP protection, and method-of-use claims often fail to defend a market position.
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