Biomolecules - The elixir of existence

Omnipresent in all living organisms - they are the drivers of their host’s growth through their products termed as biologic agents. Biopharmaceuticals on the other hand are medical drugs manufactured with the help of biotechnological innovations such as genetic engineering and recombinant human technology. Alternatively, it may be defined as medically useful drugs produced by bio-processing the biomolecules which these living organisms produce. Useful as therapeutic and in-vivo diagnostic tools, they differ from conventional chemical drugs chiefly in the way, they are sourced - that is by methods other than direct extraction from non-engineered native sources. Traditionally many diseases have been cured with therapeutic strategies focusing primarily at eradication of disease pathogens by combining both surgical and non-surgical approaches along with anti-microbial therapy. However, reports state that some of these treatments at times fail within 9 months, this is either due to inability of the conventional diagnostics to measure the actual current disease status or due to the fact that most of these conventional drugs are effective in a limited number of patient communities. Increasing number of adverse drug reactions including fatalities has also fuelled the rush to develop newer agents that focus on the identification and study of genome for a robust identification and quantification of the treatment outcome. Another reason for these recent developments in the arena of biopharmaceuticals is that patents on many small molecule generic drugs are near expiry pushing pharmaceutical companies headlong to extract profits from the biopharmaceutical market. A ramped up research in this field is also because of the way biological medicines work by closely interacting with human body to produce a favourable outcome. Thus, these can be personalised to hit the desired target with a great precision. These agents have high sensitivity, specificity and high predictability. Potential immunogenicity, higher costs, lack of consistency across all age groups and ethnicities and storage are the areas of concern. The first generation of materials were developed with bio inertness as the primary quality, the second generation materials targeted bioactivity. Lately matrix and scaffold based tissue engineering products such as bone morphogenetic proteins and platelet and fibroblast derived growth factors have hit the market. Mesoporous silica nanoparticles and chitosan based nano fibres are also being developed especially for a 3D reconstruct. Many of these materials are being used in Regenerative Periodontology. Utilising the qualities of previous generation materials with added advantages to expand the scope of predictability and efficacy, the use of biopharmaceuticals is growing steadily with new drugs constantly being introduced. Few of these agents help in identification while others are channelled towards monitoring the progress of a disease or for evaluating the therapeutic effectiveness. These new agents can become the basis for preventive periodontics as they help in quick recognition of the disease and take immediate remedial measures to arrest it’s progress. Biopharmaceuticals are now seen as the key to personalized medicine providing tailor-made treatment to the individuals for highly efficient interventions in disease process. However, in many scenarios the evidence which supports the use of biopharmaceuticals as opposed to traditional therapeutics has not yet been fully documented. The role of genomics in the field of biopharmaceuticals has been highly complex. New knowledge from the human genome project named as Nutrigenomics combined with Pharmacogenomics and Toxicogenomics are cumulatively helping the body to repair itself rather than placing some extrinsic replacements. Despite many advantages the complexity of genomic structure and function along with disease heterogeneity and contribution of other factors like environment and epigenetics have contributed to the challenges associated with this field. Yet another challenge is defining the moral, legal and ethical boundaries vis a vis using the bio- pharmaceuticals. The issue no doubt is critical because suffering patients are ever willing to try a new therapy and researchers need to prove that clinical trials remain undistorted because of this push. These concerns further become important in view of the treatment costs involving these biologicals which may be beyond the reach of an average patient. Protecting patient privacy is another key concern. All stakeholders like doctors, insurers and health plan sellers have ethical, legal and moral obligation to keep patient’s health care information absolutely protected. The prime need is to sensitize all these stakeholders to prevent any breach of privacy more so when biologicals involve genomics/stem cell therapy.

Science moves faster than regulation but ethics and other similar issues should not fade away in the name of research.

ISPlendidly yours