Host cell proteins (HCPs) in biopharmaceuticals must be controlled in the downstream process (DSP) of antibody production, since it has critical influence on product quality. Generally, the majority of HCPs in harvested cell culture fluid are removed during the affinity step using Protein A chromatography resin, and the remaining HCPs are remove in the polishing step by a combination of ion-exchange chromatography, hydrophobic interaction chromatography, etc. Thus, identification of remaining HCPs after Protein A affinity chromatography process can work as…

Small synthetic ligands have established themselves as an essential component of modern downstream processes, both as specific ligands for product capture or the targeted removal of impurities and more generally for product polishing applications. Historically, the identification of a specific ligand for a target protein has required the engagement of specialist companies. Whilst this approach can be very successful, such studies often require some time to set-up and perform (i.e. from ligand discovery, to adsorbent/process development and finally manufacture) and…

Here, we report the simple and rapid GlycanAssureâ„¢ workflow that combines high throughput and high resolution glycan analysis of 96 samples in 7-9 hours using Applied Biosystemsâ„¢ 3500xL 24-capillary electrophoresis system. The process eliminates vacuum drying and highly toxic cyanoborohydride in the labeling reaction. Use of Dynabeadsâ„¢ magnetic beads for glycan purification post deglycosylation and removal of free dyes after labeling streamlines the process for automation. Capillary electrophoresis can detect less than 0.2 fmol/μL of labeled glycans. Two proprietary fluorescent…

Advances in biotherapeutics are generating a wider range of biomolecules that are presenting unique and often difficult separation and purification challenges. Based on the complex needs of the industry a series of HIC prototypes were developed over a range of hydrophobicity. Utilizing extensive user input, design goals focused on development of resins with market leading resolution and capacity, as well as optimized surface and flow characteristics for increased throughput and high product recovery. All of which are typical pain points…