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Global and India’s biotechnology industry plays a pivotal role in driving research, fostering innovation, and developing ethical solutions to address the complex challenges in drug development.
Dr. Cyrus Karkaria, president – biotech businesses, Lupin Limited and Sanjay Tiwari, vice president - R&D (Biotech), said that several fundamental workhorse techniques derived from biotechnology, such as ELISA, SPR, and in-vitro cell-based potency assays, are widely used for drug design in early development stages and for confirming quality during analytical assessments or comparability exercises.
Use of cells and enzymes is the primary method for biosynthesis of complex therapeutics like recombinant proteins, mAbs, enzymes, conjugated proteins, RNA, and genes. While it is impossible to synthesize a large molecule chemically, it is well-known that a peptide produced using a biological system would be several times cheaper than one made by chemical synthesis. Though this enhances the sustainability features of a biotechnology product, the challenge of longer development timelines has often led the industry to favour chemical synthesis routes, they added.
However, recently, extensive use of advanced techniques for characterizing primary, secondary, tertiary, and higher-order structures of complex therapeutics has been successfully employed to secure a clinical waiver during biosimilar development. Biological therapies are more effective at treating complex and difficult diseases. However, access to affordable healthcare depends on competition and requires the entry of multiple biosimilar companies. Europe and the US now have more than 100 and 50 approved biosimilars, respectively, and the number continues to grow each year. This is indeed a positive development for patients in need worldwide, said Dr Karkaria.
Chiming on a similar note was Sanjay Tiwari who said that use of optimal scales and innovative technologies like affordable cell culture media and continuous processing has enabled the optimization of both direct and indirect manufacturing costs of the drug substance. The feasibility of 10 US$/g of protein is definitely a hot topic for reducing the overall cost of such therapies. While these factors are crucial, it is equally important to use advanced techniques in developing clones and validate a robust control strategy to ensure consistency in product quality irrespective of scale and location. This has easier access to drugs by way of decentralized fill-finish facilities globally and build continuous improvements for better sustainability.
Artificial Intelligence and big data in biotechnology gain over conventional approaches in that they enable extracting patterns from existing voluminous data sets, including clinical results and molecular-level mechanisms of action. This is not only beneficial in designing new drug candidates but also useful in repurposing existing drugs. Similarly, big data offers the potential for personalized medication based on an individual’s medical history and genetic profile. The acceptance by health agencies is an important milestone that still needs to be achieved, and a key step in that direction would be to thoroughly validate the entire approach using AI and big data in drug discovery. While AI can process data quickly, it will need to learn how to handle conflicting data. Additionally, a formal, collaborative, agreement among legal, regulatory, pharmaceutical companies, and scientific experts is essential. Adopting new developments, upholding ethical guidelines, and managing challenges are essential factors in optimizing the impact of advancements in biotechnology, they said.
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