The current paradigm for raw material control in the biopharmaceutical industry remains a
combination of compendial tests, function-based test and engineering controls. Moreover …

Injectable protein-based medicinal products (drug products, or DPs) must be produced by
using sterile manufacturing processes to ensure product safety. In DP manufacturing the …

The field of stem cell research has taken a leap forward with the discovery of human
reprogrammed stem cells (hiPSC). The potential of this technology will allow us to discover …

The development of a biopharmaceutical manufacturing process involves an assessment of
all possible sources of variation throughout each of the unit operations in the drive toward …

Air–liquid interface rings were observed on the side walls of stainless steel buffer vessels
after certain downstream buffer preparations. Those rings were resistant to regular cleaning …