Highlights•The critical quality attributes of biosimilarity are reviewed•Regulatory and
statistical considerations are summarized.•Importance of glycosylation analysis during …

N-glycosylation is a post-translational modification that occurs during the production of
monoclonal antibody (mAb) therapeutics. During production of mAb based therapeutics the …

The effects of high pressure and low temperature on the stability of two different monoclonal
antibodies (MAbs) were examined in this work. Fluorescence and small-angle neutron …

Glycosylation is considered as one of the crucial critical quality attributes of therapeutic
glycoproteins and for their biosimilar counterparts. Carbohydrate moieties of such …

The development of processes for the production of biologics using principles of quality by
design (QbD) has started to gain momentum. However, not all stakeholders are fully …

Monoclonal antibodies (mAbs) make up the largest class of biologics on the market today
based on their use to treat a myriad of diseases such as cancers, and autoimmune diseases …

Coupling CE with MS presents some challenges. Here, we discuss the advantages of CE–
MS over LC–MS, and the parameters that are important to obtain a stable CE–MS …

In this article, we discuss the use of CE-MS (sheath flow interface) for analysis of intact
proteins as well as of protein digests. We discuss the unique aspects that the user needs to …

Monoclonal antibodies (MAbs) are a relatively recent class of drugs that have introduced
new curative strategies in an emerging precision medicine paradigm. MAbs have high and …

The rapid advancements in the field of biopharma have increased the demand for analytical
techniques that can accurately fingerprint the analyte (1). This challenge takes on a whole …