Manufacture of biologics is entering a new era as the power of evolutionary genetics brings to power of the full genome to the optimisation of host cells for specific commercial and technical needs of each project.
This is set to have an increasingly disruptive influence in biologics manufacture, especially in the following areas:
- When standard chassis or engineered variants do not produce viable manufacturing solutions for the biologic concerned.
- The goalposts of success are moving with formally viable solutions created using standard chassis no longer competitive against manufacturing using optimised host cells.
- The most efficacious mechanisms of action of new drugs are often multi-valent to which monoclonal antibodies are poorly suited. New classes of biologic are emerging to which optimised host cells offer an ideal efficient, consistent, scalable and low cost means of manufacture.
The key to establishing the best manufacturing solution for any given project is to create a detailed specification using all the pertinent criteria. Care is required to ensure all the potential solutions are objectively considered without undue bias and/or vested interest.
The arrival of QTL technology to biologics manufacture offers to create substantial opportunity both in therapeutic biologics as well as offering viable solutions to some of the issues that have been stifling progress in synthetic biology. The genomics of the optimised strains offer a basis for strong patent protection locking in the competitive advantage of those that adopt the new approach.
