Abstract

Challenges and Prospects in Biopharma industry: Application of Mass Spectrometry

Utpal Tatu, Professor, Indian Institute of Science

With the overriding success of Indian Pharma the attention is gradually turning to biopharmaceutical industry in India. Biopharma industry in India is one of the fastest growing in the world and India is also emerging as one of the biggest markets for biopharmaceutical products. The market is still in nascent stage and offers an early advantage to companies which can get their strategy right. These opportunities are tied together with certain challenges. Can we deliver quality bipharma products that can compete internationally and gain acceptance in the world market? Answer to this question will lie in the quality control and technical expertise to evaluate biosimilars in the Indian industry. This is increasingly becoming essential for better understanding of structure-function relationship and to study process consistency.I will highlight key technical issues faced by the biosimilar industry in India with top tips to ensure success in the characterization of biopharma products.