2018 Collection Archives - BioProcess InternationalBioProcess International

Characterization and Lot Release Assays for Antibody Drug Conjugates

Antibody-drug conjugates (ADCs) add an additional level of challenge to testing of biotherapeutics. Besides the antibody, which needs to be evaluated for potential and known mechanisms of action (MoA), there is a cytostatic compound conjugated that alters the behavior of the antibody-vehicle within the typical assays. Therefore, characterization of new innovators as well as biosimilarity assessment is even more challenging than it is for antibody therapeutics. Using the example of Trastuzumab emtansine, Charles River has set up a panel of…

Removal of Isoagglutinins from IVIG and Plasma Using Affinity Chromatography

by Bastiaan Lobbezoo, Lucy Pepperell, Patrick Gurgel and Steve Burton

Antibody-mediated haemolysis is a hard-to-predict phenomenon with potentially severe consequences. It is mediated by naturally-occurring anti-A and anti-B immunoglobulin isoagglutinins, which are present in plasma, blood, and several derived products, including IVIG produced by plasma fractionation. Prometic Bioseparations have developed an affinity chromatography resin for the removal of isoagglutinins from plasma and plasma derived products, such as IVIG. The resins, IsoClear A and IsoClear B, can clear isoagglutinins from a titre of 1/32 down to negative agglutination using a load…

Expansion, Recovery and Characterization of hMSCs on Dissolvable Microcarriers for Bioprocess Applications

by Jeffery J. Scibek, Jennifer L. Weber, Lori Romeo, Paula Dolle-Sonneville and Yue Zhou

Human mesenchymal stem cells (hMSCs) are currently the most common adult stem cell type used for cell therapy applications due to their regenerative properties and ability to differentiate into multiple cell lineages (adipocyte, chondro¬cyte, and osteocyte). Traditionally, hMSCs have been cultured on two-dimensional cell culture platforms using serum-containing medium. Although these platforms can be used successfully for small-scale expansion of hMSCs, other platforms will be required to generate the quantity of cells required to support the increasing number of clinical…