Friday, September 3, 2021 Daily Archives

New Antibody Formats on the Block:
More Complex Modalities Demand Innovation in Manufacturing and Purification

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Some of the latest, most promising therapeutic developments in the biologics industry use antibody fragments — either separate functional subunits of antibodies or recombinant molecules that are composed of immunoglobulin domains. The most popular fragments are antigen-binding fragments (Fabs), variable single-chain fragments (scFvs), diabodies, and nanobodies. Such molecules raise several advantages over their parent molecules for upstream production but pose several challenges for downstream purification. To facilitate antibody-fragment capture, Tosoh Bioscience has developed Toyopearl AF-rProtein L-650F resin. Its ligand uses…

September 3, 2021

Biosimilar Structural Comparison of Commercially Sourced Reference Standards by MMS Rapidly Detects Subtle but Critical Differences to Correctly Predict Activity for Use in an ELISA Product

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It was determined that many of the Bovine Serum Albumin (BSA) reference candidates did not exhibit acceptable activity after inclusion into the final product though all purchased samples shared the same name and identification. The inconsistency in activity causes delays, increases cost of manufacture, and adds an element of variability. Current in-house biophysical techniques fail to correctly identify the inactive candidates prior to product inclusion due to inconclusive results or a lack of sensitivity. Thus a more accurate, reliable analytical…

September 3, 2021