Pressures to accelerate current and next-gen therapies are challenging traditional microbiological testing methods.

Advances in cell line engineering, process optimization, and in-vitro glycosylation are making a difference.

Cell therapy companies are attracting interest from investors, and drug companies are seeking partnerships and acquistions to accelerate development.

Early successes drive the need to overcome safety issues, increase efficacy, and address manufacturing challenges.

Developers of CAR-T cell therapies with products showing successful early-stage clinical results are currently seeking manufacturing capacity that will enable the production of the larger quantities of material needed for Phase III trials and eventual commercialization.

Two main safety issues have been identified in the early-phase clinical trials conducted to date for chimeric antigen receptor (CAR)-T cell therapies.

Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing

Scale-down modeling accelerates the development of downstream biopharma manufacturing processes.

Collaborative efforts are underway between suppliers and drug manufacturers to address raw material variability.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Time and sensitivity are essential for analytical technologies in all phases of biopharma development.

New technologies must meet the speed, sensitivity, and safety demands of emerging bio/pharmaceuticals.

Scale-down modeling is instrumental in supporting the development of downstream biopharma manufacturing processes.

Expectations are high for rapid testing methods, but demonstration of comparability proves challenging.