The human body is complex. Even though the human genome project found only 3 million single nucleotide polymorphisms (SNPs) between two random individuals translating to a 99.9% genetic similarity, our species exhibits considerable differences in both appearance and physiology. The variations manifest not only in how we look but also in how our bodies react at the molecular level. This reaction is often perceived in drug-molecule interaction. For instance Warfarin, an anticoagulant, would not do what it is supposed to if a person’s CYP2C9 gene has a variation of some sort. It can be said that this is owed to perhaps a mutation, but then scientists have also gone on to say that the 0.1% difference, the 3 million SNPs, account for majority of the information on our diseases and the way we metabolise drugs. Because any individual variation can result in major differences in drug response, it would be fair to say that the concept of “one size fits all” in medicine should perhaps be “one size fits most”. With a “major” genetic difference (the 0.1% variability between individuals), this rephrasing might also be insufficient. The reasons given so far ultimately demonstrate the need for personalised medicine. Also called precision therapeutics, precision medicine has created a paradigm shift in healthcare and with its subset ‘precision bio-therapeutics’ focused on biopharmaceuticals, personalised medicine has seen advancement.
With medical interventions focusing on individuals based on their genetic make-up and environmental and lifestyle factors, the traditional “one-size-fits-all” model of treatment is certain to be replaced with a “one-size-fits-one” model.
‘Precision bio-therapeutics’ combines the principles of precision medicine with the power of biotechnology, the purpose being development of specific and effective therapies targeting individuals at molecular level .
The benefits have long been evident with extensive research, such as with development of monoclonal antibodies (mAbs). For instance Trastuzumab (Herceptin) – a monoclonal antibody, targets the HER2 protein in breast cancer and induces an immune mediated response that results in recycling and internalisation of HER2. Given to only HER2 positive patients and produced in Chinese hamster ovary using rDNA technology, this mAb is a boon to breast cancer treatment.

Yet another promising derivative of the precision bio-therapeutics is the RNA-based therapies, for example the use of Patisiran for hereditary transthyretin-mediated amyloidosis (hATTR). This drug goes through a complex process in the liver and ultimately renders the abnormal transthyretin mRNA non-functional.
CRISPR based technologies have led to a further advancement in bio-therapeutics, exemplified by CAR T-cell therapy. Chimeric antigen receptor (CAR) T-cell therapy, involving genetic modification of patient’s own T-cells to target specific antigens, has resulted in improved efficacy in haematological malignancies.

Precision bio-therapeutics’ advancement is dependent on advancement in technologies. Proteomics and metabolomics have to provide bio-therapeutics with crucial patient information . Thus even with such huge potential and promise, precision biotherapeutics is under a challenge. However it can be said that with improved understanding of human biology and advancements in technology, precision bio-therapeutics is poised to revolutionise healthcare with personalised medicine.

Hibban Showket

University/College name : Hansraj College, University of Delhi