USFDA 505(b)(2) pathway submissions (“(b)(2)s”) can be advantageous because they offer the potential for the accelerated approval of patient-centric medicines.
Sentry Biopharma Services protects the integrity of temperature sensitive biopharmaceutical products during the clinical and commercial phases of development.
CM has the potential to drive productivity and improve safety and product quality but the shift from batch processes requires a robust foundation of knowledge.
Mara van Haandel, Innovation Program Director, DFE Pharma, Gericke Bernhard Meir, Head of Continuous Manufacturing (OSD), Gericke AG05.27.22
The 45,000 sq. ft. facility in Texas to produce viral vectors and cell-based products used in cell and gene therapies, vaccines and oncolytic therapies.
Expansion will double the site’s existing lab footprint with an addition of 89,000 sq. ft equipped with state-of-the-art instrumentation and technologies.
CBM turned to Utah-based Navigator Business Solutions to implement a foundational ERP system that supports the process automation needed for continued expansion
30,900-sq.-ft. facility in Princeton, NJ houses 16 suites for cGMP product production, and labs for analytical, quality control and microbiology testing.