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Published on : Dec 31, 2015

Biopharmaceuticals are touted as the most elegant and sophisticated achievements in the modern science. These drugs usually have huge and complex structures, which don’t just look extraordinary in their 3-D modelling systems, but they also have proved to perform their tasks incredibly well. These drugs are preferred by not just doctors but by patients as well, since they offer high efficacy with fewer side-effects. Despite exhibiting a significant success in the global arena, biopharmaceuticals are facing operational and technological challenges. 

The industry is finding it difficult for reproducing large molecules consistently at an industrial scale, which needs a more flexible and sophisticated approach. For instance, a molecule of aspirin constitutes 21 atoms, hence a biopharmaceutical molecule may contain anything between 2,000 and 25,000 atoms. The “machines” presently used for producing recombinant therapeutics are modified genetically from living cells and must be frozen for storage. After which they require utmost care to be thawed without damage, and finally made to survive in the most unusual environment of vessel used for reaction. After these steps, the molecules are separated from the cells from the media in which they were produced and from the cells that made them. And this has to be achieved without destroying or hampering their fragile structures in any way. 

Over the past few years, the safety, high level of efficacy, and unparalleled ability to address previously untreated health conditions of biopharmaceuticals rendered pharmaceutical companies opportunity to command high prices for the same. Owing to strong demand for the treatment of such conditions, the biopharmaceutical companies were able to mull impressive profits, despite the high cost of the goods sold. The advent of biopharmaceuticals in the pharmaceutical industry also set new standards for the blockbuster drugs. Traditionally, blockbuster drugs entail drugs with annual sales of US$1.0 bn or more.  However, the market for blockbuster drugs suffered from the advent of effective biopharmaceuticals in the market. 

As biopharma witnesses a paradigm shift from the scientific frontier to mainstream business, the industry will come face to face with major challenges that is common in a business milieu. The biopharmaceutical industry will therefore, have to deal with the challenges of sustaining competitiveness by ensuring quality products at affordable prices and delivery performance.