29 Quick Evaluation of mAb Glycoforms and ADCC Activity
TSKgel FcR-IIIA-NPR, a new HPLC column developed by Tosoh Bioscience, can provide valuable information on antibody biologic activity and glycoforms in many phases of development and production. This new affinity column is based on a recombinant Fc gamma IIIa receptor ligand immobilised on a non-porous polymer particle.
Fc gamma IIIa receptor plays a key role in antibody-dependent cell mediated cytotoxicity (ADCC) which is a crucial mechanism of action of anti-tumour mAbs. These Fc-mediated effector functions are known to be related to Fc-glycans of antibodies. Hence, separation patterns of therapeutic antibodies on TSKgel FcR-IIIA-NPR can be correlated to both glycan pattern and the ADCC activity of immunoglobulins. Early eluting peaks of TSKgel FcR- IIIA-NPR represent glycoforms with low ADCC activity while late eluting peaks represent glycoforms with high ADCC activity.
The rapid thirty-minute separation allows the analysis of large numbers of mAb samples to
gain valuable first information on the distribution of glycoforms and expected ADCC activity. This fast and efficient method can be applied to purified samples and supernatant alike and can therefore be used in many phases of development and production such as cell line screening in early R&D, biosimilar/originator comparison, upstream development and optimisation, monitoring of glycoengineering, or lot-to-lot comparison in QC.
More information online:
ilmt.co/PL/OKAm
Diagnostic Solutions Supporting the Battle Against COVID-19
In the diagnostics field, Tosoh is developing solutions for both detecting the SARS-CoV-2 RNA during acute infections and detecting antibodies specific to SARS-CoV-2 through serological tests in patients who symptomatically or asymptomatically contracted SARS-CoV-2. Tosoh Bioscience’s chromatography experts are focusing their technological leadership on chromatography materials to support the development of methods for the analysis and industrial production of therapies, vaccines, and diagnostic solutions at their biotech and pharma customers.
Scientists worldwide are currently developing many vaccine and therapy projects using TOYOPEARL, TSKgel, and Ca++
Pure-HA® chromatography media. The
experience and reliability of Tosoh Bioscience ensure navigating safely through the clinical trials to launch biotherapeutics.
Tosoh Bioscience ensures the availability of these products on a production scale throughout the crisis. The on-going race against Coronavirus makes it more evident than ever: scientists need to develop biotherapeutics and vaccines as fast as possible. Tosoh Bioscience launched SkillPak™ 1 and 5 mL pre-packed columns. Those pre-packed chromatography columns provide a toolkit that supports fast purification method development.
The characterisation of monoclonal antibodies is crucial for both diagnostic and therapeutic applications. In diagnostics, antibodies are used to produce serological tests, and avoiding false-positives and false-negatives are key. This can only be achieved if the renowned test kit suppliers can be 100% sure of the quality of the antibodies. On the other hand, when producing antibodies for therapeutic applications, a precise characterisation is mandatory to avoid adverse effects, to increase the chances of successful clinical trials, and to ensure patient safety when going into production. Tosoh offers robust and reliable solutions for the analysis of antibodies at all these stages.
The separation of mAb monomers from their aggregates is one of the essential assays in mAb development and manufacturing. For decades, the TSKgel G3000SWXL
size exclusion chromatography (SEC) column has been the gold standard for aggregate detection in the biopharmaceutical industry. Many scientists are developing their analytical methods during the current crisis using this well-known and robust HPLC column.
Tosoh Bioscience offers a variety of chromatography media and HPLC columns that can support the research, development, and production efforts in the fight against COVID-19. Moreover, they can speed-up the on-going development race through the pre-clinical, clinical, and production phases through their expertise.
More information online:
ilmt.co/PL/0gZn
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