Primary clarification is an essential step in a biomanufacturing process for the initial removal
of cells from therapeutic products within the harvested cell culture fluid. While traditional …

Mutations in the C-terminus of human erythroid 5-aminolevulinate synthase (hALAS2), a
pyridoxal 5′-phosphate (PLP)-dependent enzyme, are associated with two different blood …

Real‐time monitoring of cell cultures in bioreactors can enable expedited responses necessary
to correct potential batch failure perturbations which may normally go undiscovered until …

A mycoplasma contamination event in a biomanufacturing facility can result in costly cleanups
and potential drug shortages. Mycoplasma may survive in mammalian cell cultures with …

β-Glucuronidase is a lysosomal enzyme and a molecular model of a class of therapeutics
approved as enzyme replacement therapies for lysosomal storage diseases. Understanding …

Monoclonal antibodies (mAbs) are one of the most popular and well-characterized biological
products manufactured today. Most commonly produced using Chinese hamster ovary (…

Bioreactor parameters can have significant effects on the quantity and quality of biotherapeutics.
Monoclonal antibody products have one particularly important critical quality attribute …

Culture pH is a critical process parameter during CHO cell bioreactor operations that is key
for proper cell growth, protein production, and maintaining the critical quality attributes of a …

Capture bioprocessing unit operations were previously shown to clear or kill several log10
of a model mycoplasma Acholeplasma laidlawii in lab-scale spike/removal studies. Here, we …

Mycoplasma contamination events in biomanufacturing facilities can result in loss of
production and costly cleanups. Mycoplasma may survive in mammalian cell cultures with only …