Jill Murphy

According to the press release, it is the first turn-key device to utilize Raman spectroscopy for bioprocess control, with no modeling and development required.

Leaders at CDER and CBER give update on organizational changes at FDA.

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

AI’s role in target discovery and manufacturing optimization remained the most chosen application looking three years ahead; however, approximately 43% envision that it will help to build base regulatory submissions.

Apollo is a part of a research and development platform for the development of new medicines, with program selection being hesitant to indication and primarily driven by quality of science or the potential to transform the standard of care in major commercial markets, according to the press release.

The companies are collaborating to apply ShapeTX’s AAVid capsid discovery platform and transgene engineering technology in addition to Otsuka’s expertise in genetic payload design and ophthalmology to develop novel treatment options for eye diseases.

Recipharm will provide analytical and process development capabilities to support toxicology studies, in addition to GLP manufacturing of lipid nanoparticles to capture the active pharmaceutical ingredient, an antigen peptide.

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

Despite the successes that have already been achieved with emerging therapy development and manufacturing, companies are still facing numerous challenges.