05.06.26 -- Organic Impurities: New Draft ICH Q3E Guidance For Leachables And Extractables

Look at how denaturing SEC‑MS uncovers low‑level oligomers and truncated variants in GLP‑1 peptides, offering clarity on impurity profiles and supporting confident assessment of molecular integrity.

Clarifying post–virus inactivation streams with a charged depth filter can remove precipitates while significantly reducing HCPs. See how a dual‑layer filtration approach supports stronger impurity control.

Conventional electroporation methods struggle with damaging heat buildup. Discover how innovative flow technology leverages physics to protect cells and enable large-scale therapeutic production.

Explore a unique model to predict injection force designed to decorrelate factors linked to formulation development and the ones linked to container and delivery device selection.

mRNA has emerged as a promising modality offering a great deal of versatility for a wide range of therapeutics and vaccines with its use of non-viral delivery systems.

See how controlled ice nucleation shortens lyophilization cycles, supports higher drying temperatures, and reduces complexity for amorphous and mixed formulations without sacrificing quality.

Modernize sterile manufacturing with robotic fill-finish systems. Achieve multi-format flexibility and risk reduction to meet the rigorous demands of personalized medicine and small-batch production.

Review strategies to assess the potential for human immune response following the administration of an mRNA therapeutic, the associated LNP, and the protein encoded for by the mRNA.