This webcast features: Sharon Bola, Global Product Manager, Process Chromatography, Bio-Rad Laboratories. With the increasing global demand for insulin product, there is a need to develop a more efficient and economical process for the production of recombinant insulin therapeutics. In this webcast, we will present an efficient downstream processing workflow for recombinant human insulin production using Escherichia Coli as the host system. Data will be presented for sample preparation and purification results of proinsulin and insulin. Size exclusion was identified…

Alternative stationary phases are being developed to solve the shortcomings of bead chromatography processes, namely high diffusional resistance leading to long processing cycles (4–6 h). Targeted lifetimes of 75–150 bind and elute cycles, taking sometimes years to achieve and requiring cleaning and respective validation, storage, and column unpacking and repacking, elevate costs and introduce increasingly unacceptable bioburden risks. Chromatographic membranes, due to intrinsically high mass transfer rates, overcome these limitations, enabling residence times of seconds and full lifetime utilization (75–150…

This webcast features: Shawn Fitzgibbons, Senior Manager & Jacob Kraus, Manager, Biologics Analytical, Catalent. The heterogeneity of a biologic product has implications for the safety and efficacy of the final biotherapeutic or biosimilar therapy. It is important to characterize the charged variant profiles of biologics, since many important post-translational modifications (PTMs) impart or alter the charge (isoelectric point or pI) of the molecule, potentially impacting stability, pharmacokinetics, and pharmacodynamics. Examples of charged variants include lysine variants and deamidation products, both…