The delicate nature of biopharmaceutical species, such as MABs, can make traditional separation and characterisation techniques inappropriate. Dr Thorsten Klein, of Postnova Analytics, Germany, examines the forms and applications of Field Flow Fractionation (FFF) as an alternative.
The nature of drug development has changed immeasurably over the past couple of decades, with an increased focus on biopharmaceutical solutions and, consequently, the behaviour of biological molecules in formulation.1 In particular, monoclonal antibodies (MABs) are a relatively new biopharmaceutical development that has stimulated a variety of academic, medical and commercial interest.2
Monoclonal antibodies represent an ingenious manipulation of the body’s immune system for targeted therapeutic purposes. Within the body, beta cells produce individual antibodies targeted at a specific foreign species, such as a virus or cancerous cells. Antibodies attach to specific epitopes, short amino acid sequences on the surface of the undesirable species, acting as beacons for phagocytes, which locate and destroy the antigen. This can be used in the form of a doseable therapeutic treatment through the creation of a monoclonal population of beta cells producing antibodies targeted to a specific antigen.2
Antibody-based treatment has emerged as a broadly applicable technique with innumerable applications for a wide range of academic, commercial and medical uses and significant revenue potential.3 One of the most widely known applications for MABs is within cancer treatment, ranging from use in traditional radio immunotherapy techniques to directly target the walls of cancerous cells. Use of MABs has even been suggested for ‘untreatable’ diseases, with some research suggesting a potential treatment for HIV/AIDS.4
One issue that arises during the production of MAB species is the aggregation of the protein species during formulation. Naturally occurring protein aggregation within the body can lead to significant neurodegenerative issues, such as Alzheimer’s or Parkinson’s disease. Similarly, the presence of aggregated species within therapeutic proteins can have a serious effect on drug performance, influencing key characteristics such as drug activity and bioavailability, potentially causing severely negative immune reactions. Separating and analysing the presence of these species are key to the formulation, stability and bioavailability.5
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