Quality by Design (QbD) methods have been used to improve processes across a variety of fields. The biopharmaceutical sector has recently embraced these methods, with the FDA advocating their use, to ensure consistent product quality and lower product development and manufacturing costs. Read more.
Biochemical assays for monitoring protein aggregates often rely upon ultracentrifugation, size-exclusion chromatography, gel electrophoresis, dynamic light scattering, or turbidity measurements. Read more.
As cell culture technology improvements continue to result in monoclonal antibody expression level increases, the protein manufacturing throughput bottleneck has shifted to downstream purification. Read more.
Peptide therapeutics have been recognized as delivering the best of both worlds in terms of small molecule synthesis efficiency and biologics efficacy and reduced toxicity. However, challenges in mass production and low oral availability have historically made them less than ideal drug candidates. Read more.
Ceramic hydroxyapatite, or CHT, is a versatile chromatography support used for the separation of biological molecules including polyclonal and monoclonal antibodies, antibody fragments, enzymes, nucleic acids, and membrane proteins.