Antibody based therapeutics account for 40% of the entire biotech drug market. In 2012 alone, the total antibody drug production exceeded $50 Billion in sales value (1). Monoclonal antibodies are becoming the leading driver of the therapeutic product pipelines. Together with the increased number of drug candidates comes the challenge of ensuring that an adequate, low cost, safe, and scalable manufacturing capacity exists and is able to address the ever increasing complexity of these bio-therapeutics.

Due to their mode of production, monoclonal antibodies are complex and heterogeneous molecules.
When changes are made to the manufacturing process of a therapeutic monoclonal antibody, an extensive comparability study has to be performed to comply with the requirements of ICH Q5E guidance[1]. These studies usually require the use of many orthogonal analytical techniques in order to fully characterise the different variants.

Monoclonal Antibodies (mAbs) with selectivity towards antigens located on the surface of cancer cells have been successfully developed. Nonetheless, mAbs alone are generally not potent to kill the cancer cells and are therefore used in combination with classical chemotherapies.

Even though much progression has occurred in terms of quality and compliance in the biopharmaceutical environment, the industry is still mired in vague definitions of “decontamination” very often leading to amalgams with the actions of “cleaning” and “disinfection”. This confusion, particularly in the bio-pharmaceutical realm of infectious antigens and particularly viruses, leads to situations of non-technical mastery, non-compliance and ultimately increased risk of cross contamination between products. All of which stress the importance of clarity in biocontainment.