By Pratibha Raju and Abhijeet Singh

New Delhi: peptides And oligonucleotides are complex and these drugs are magical in terms of how they can treat disease conditions. Chief Scientific Officer Dr. Manoj Pannachukunath said that these are complex molecules, in which developed countries have great interest. biocon Who played a key role in ETpharma Biomolecule Workshop and Connect, Mumbai Chapter event. Addressing the spellbound audience he delivered an enlightening keynote address on ‘Cracking the Code of Complexity’ medicines: Important Exploration quality properties In peptides and oligonucleotides.

In his address he provided his valuable insights industry players To get regulatory approvals for their product and solved various problems they faced mid-process.

One of the major issues he mentioned was the absence of specifications and methodology in the industry that prevents companies from testing their product under different conditions. He further said that their approval applications are being rejected due to variations, and some companies are reluctant to rigorously test their drugs.

Emphasizing on the responsibility and accountability of companies to ensure the safety of patients as well as the efficacy of medicines, Dr Pannachukunath said, “Just testing the product for quality is not enough. What is even more important is that you How do you make it manufacturing process,

He said, “Testing a batch for quality is just a validation, a random confirmation that the processes, practices, and material sourcing philosophy chosen, all converge to a point that you have a product that meets safety requirements. Does.”

Providing clarification while talking about the difficulties faced by manufacturers due to variation in Indian and global regulations, he said, “Indian regulations talk more about purity, they say that the product has to be 99 per cent or 99.5 per cent pure. Should, but global rules don’t do it. Even accepting the expectation of purity, they talk about the level of impurity and impurities.”

In his presentation the expert briefly described the various technologies used in the pipeline for production of peptides and what issues manufacturers may face and how to address them, he also provided insights related to quality control mechanisms. Shared.

Dr. Manoj also shared some data points from various analysts which suggested that the peptide industry will grow at the rate of 9.1 percent. CAGR (Compound-Annual Growth Rate) and is expected to reach $100 billion by 2033, while the Oligonucleotides industry is projected to reach $44-45 billion with a CAGR of 7.1 percent in the same period.

In his concluding remarks, he focused on the importance of monitoring the manufacturing processes and sought analytical expertise from industry players to understand the physical characteristics, process parameters, QBD and testing, characterization and most importantly the quality compromises To get the license easily without the urge to understand the product. Standards and patient health.