Monoclonal Antibodies – challenges with current production techniques
Monoclonal antibodies are increasingly used in a wide spectrum of therapeutic and diagnostic applications and global production levels are growing by 10% annually. To date, a number of prokaryotic and eukaryotic cell expression platforms have been employed for antibody manufacture. However, these production techniques often have poor yields and high unit manufacturing costs when compared with small chemical entities and this in turn often limits the suitability of antibodies and other biologics as a therapeutic agent when tackling high prevalence diseases with large patient populations.
The high manufacturing cost and long timelines to potential commercial realisation can often present a barrier to entry for small biotechnology companies looking to translate their early discovery therapeutic antibody projects though preclinical development into early stage clinical trials and reach key decision (and investment) points in their R&D programmes. New, plant based production platforms may provide an alternative to these standard cell expression systems and enable development teams to achieve early-stage development milestones quicker with lower unit manufacturing costs.
2G12 HIV neutralizing antibody, developed for the prevention of AIDS
One example of monoclonal antibody production in transient expression systems is a process for manufacture of the HIV neutralising antibody, 2G12, using the HyperTrans® technology in N.benthamiana. HIV is a global public health issue; in 2016 an estimated 36.7 million people were living with HIV with the majority of patients located in low and middle income countries. Economically affordable treatments are critical and plant expression systems may contribute to fulfilling this need by delivering lower cost, high yield antibody therapeutics. At Leaf Expression Systems we have recently expressed the anti-HIV antibody 2G12, in the HyperTrans® system and achieved expression yielding 0.1 mg of antibody per/g of plant tissue in a fully scalable process at significantly lower costs than could be achieved in animal cell systems. The use of the HyperTrans® system could also enhance the intellectual property protection for a development product and thus enhance its value. For more details, contact the Leaf Expressions team at [email protected]