Bioprocess Automation for PAT with BioProfile FLEX2 plus Seg-Flow

Etanercept is a recombinant Fc fusion protein therapeutic that has a complex distribution of post-translation modifications (PTM), such as N and O-linked glycans. Current CID-based MS/MS can struggle to characterize such PTMs, since side-chain species are typically fragmented via a mechanism that does not produce diagnostic ions related to the PTM localization. Other forms of fragmentation, such as ETD, can maintain side chain information but suffer from low sensitivity and scan rate, as well as inadequate coverage of low charge state peptides. In this study, a new form of fragmentation (electron activated dissociation, or EAD) was employed to comprehensively characterize the glycosylation of etanercept at the peptide level. A comparative analysis between intact/subunit and peptide mapping results was performed as a validation step for the novel EAD workflow. Three N linked glycosylations were detected, as well as nine sites of O-linked glycosylation, with high confidences, via a single, generic, data-dependent LC-MS/MS analysis. Even in challenging cases, exact positioning information of the glycosylation on the peptide could be obtained. EAD also allows for confirmation of amino acid isomers (Leu/IsoLeu and Asp/IsoAsp) via MS/MS analysis, in the same experiment.

Adeno-associated viral vectors are essential tools for delivering gene therapy to patients and are usually manufactured using plasmid-based approaches. However, there are challenges with working with plasmids on a large scale, including consistency and scalability.

Understand the update of the National Patient Safety Goals to be sure your organization is in compliance with the requirements. Each year healthcare providers must meet the requirements of the Joint Commission's National Patient Safety Goals as part of the accreditation process. Receive an overview and update of the 2019 National Patient Safety Goals. Receive practical advice to implement the goals. Failing to meet a requirement will result in a requirement for improvement. This information is critical to ensure you are aware of the requirements.

The therapeutic antibody market has reached a fever pitch of enthusiasm, in no small part due to successes of recent drug approvals for a host of disorders such as psoriasis, multiple sclerosis, C. difficile infections, and cancer.