Catalent opened a brand new commercial-scale plasmid DNA (pDNA) manufacturing facility at its European Middle of Excellence for Cell Therapies in Gosselies, Belgium. The ability, which incorporates over 12,000 ft2 (1,100 m2) of improvement and manufacturing house throughout a number of cleanrooms for CGMP-grade pDNA manufacturing for scientific and commercial-phase provide, has been designed to be EMA and FDA compliant to assist clients with necessities for high-yielding processes at 50 and 300-liter fermentation scale.
Catalent will even produce a brand new vary of off-the-shelf plasmids to assist cell and gene firms,” in line with Manja Boerman, PhD, Catalent’s president, BioModalities (Cell, Gene and Protein Therapies). These embody adeno-associated virus (AAV) pHelper, which is obtainable now, and Rep/Cap AAV2 and AAV5 plasmids, which might be out there later this quarter. Rep/Cap AAV serotypes 1, 3, 6 and 10 might be out there later this 12 months.
“Catalent permits totally built-in viral vector and mRNA companies—from our pDNA experience in Gosselies, to scientific and industrial manufacturing of viral vectors for gene remedy, cell remedy, and mRNA in our community—offering vital provide chain continuity and a single CDMO companion from lead identification to industrial manufacturing,” stated Boerman. “Plasmid DNA is a vital element to many organic therapeutics, and Catalent has made this funding in further manufacturing capability in anticipation of supporting the rising variety of packages by improvement in the direction of commercialization.”
In December, Catalent opened a cell remedy industrial manufacturing facility, additionally situated on the Gosselies campus. It homes 60,000 ft2 (5,600 m2) of devoted cell remedy manufacturing house housing multi-product, segregated suites designed to assist autologous and allogeneic cell remedy manufacturing.