What are the recent trends and regulatory challenges in the biopharma industry?
There has been a significant growth in investments from developed countries into India, particularly in startups, contract research organisations, and contract development and manufacturing organisations. The key drivers for this surge include cost efficiencies, availability of a skilled workforce, and advanced technologies. Indian startups are attracting venture capital for innovative solutions in drug discovery and biotechnology. Strategic global collaborations are also driving innovation.
However, the industry faces regulatory challenges including complex approval processes, the need for compliance with varying international standards, evolving regulations, data privacy and security concerns, and the high cost of maintaining regulatory compliance.
What is your perspective on the recent trends in investments from governments and developed countries into startups and incubation centres?
The recent trends in investments from developed nations into Indian startups and incubation centres are positive and promising. These investments are driving innovation, providing critical funding, and supporting infrastructure development, which are essential for the growth of the biopharma industry. The surge in venture capital and private equity investments into Indian biopharma startups includes investors attracted by innovative approaches and the potential for high returns. Numerous accelerators and incubators are supporting biopharma startups, providing them with the necessary resources, mentorship, and funding to scale operations.
The Indian government is actively supporting the biopharma industry through various funding initiatives and policies aimed at fostering innovation, enhancing infrastructure, and attracting investments. BIRAC and DBT offer several funding schemes such as the Biotechnology Ignition Grant (BIG), Small Business Innovation Research Initiative (SBIRI), and Biotechnology Industry Partnership Programme (BIPP) to support startups and SMEs in the biopharma sector. This combined support is accelerating the growth and success of startups and incubation centres, positioning India as a significant player in the global biopharma landscape.
India has recently witnessed a surge in startups and incubation centres. What role do you think these startups and incubation centres play in the growth story of India’s biopharma industry?
Startups and incubation centres in India play a crucial role in the growth of the biopharma industry by fostering innovation, providing necessary resources, and facilitating collaborations. They serve as breeding grounds for new ideas, driving advancements in drug discovery, biotechnology, and personalised medicine. Incubation centres offer mentorship, funding, and infrastructure, enabling startups to scale their operations and bring novel solutions to market. Additionally, these centres help bridge the gap between academia and industry, promoting research and development. Overall, they significantly contribute to the industry’s expansion, competitiveness, and global positioning.
Can you share some insights on how Agilent has been collaborating with these startups and incubators in this sector?
Agilent has introduced technological advancements and innovative solutions specifically for the biopharma market. These solutions are designed to help biopharma companies and support startups in their early-stage research activities.
Agilent 6545XT AdvanceBio QTOF: The Agilent 6545XT AdvanceBio LC/Q-TOF system is designed to manage multiple workflows in biopharmaceutical characterisation. It helps researchers access information at the intact protein level, automatically confirm a sequence through peptide mapping, and confidently understand PTMs. Unlike ion traps that emphasise mass resolution and mass accuracy capabilities, this Agilent Q-TOF combines uncompromised in-spectra detection with high dynamic range and fast analysis.
Agilent ExD Cell for LC/Q-TOF: The Agilent ExD cell is an add-on for the Agilent 6545XT AdvanceBio LC/Q-TOF which enhances the platform’s abilities to characterise peptides and proteins by introducing electron capture dissociation. The ExD cell’s high ECD efficiency extends its functionality to analytes with lower charges (≥2+), overcoming a historical constraint for electron dissociation techniques.
Agilent Glycan sample preparation kits: The Agilent AdvanceBio glycan sample preparation kits and tools offer a range of options to support N-glycan analysis. Glycan sample prep takes less than an hour with Agilent’s flagship Gly-X platform. Gly-X follows the industry-leading GlykoPrep line and is the new generation in sample preparation. Sialic acid quantitation and profiling kits are also available in both plate reader-based (Total Sialic Acid Quantitation) and LC/FLD or LC/MS (Sialic Acid Profiling & Quantitation) formats.
Agilent 1290 Infinity II Bio Online LC system: The 1290 Infinity II Bio Online LC system is an online UHPLC system designed for comprehensive analysis and real-time bioprocess monitoring in the biopharma industry. This bioprocess Online monitoring UHPLC system enables precise separation and analysis of biomolecules while providing real-time process monitoring, immediate feedback for optimisation, and significant time and resource savings.
Agilent MassHunter BioConfirm software: The Agilent MassHunter BioConfirm software enables routine characterisation of biomolecules through easy-to-use workflows for oligonucleotide analysis, intact protein analysis, peptide mapping, and routine glycan profiling. This biopharma software for LC/Q-TOF is part of a comprehensive solution for mass spectrometry analysis of biopharmaceutical products such as monoclonal antibodies and oligonucleotides.
Agilent’s collaboration with startups and incubators is playing a pivotal role in helping them achieve their business objectives. Agilent has strategic partnerships with organisations such as CCAMP and IIT Delhi, focusing on application and skill development, and these organisations are leveraging many Agilent solutions in their key projects.
Additionally, Agilent’s collaboration with the Centre for Cellular and Molecular Platform (C-CAMP) stands out. Together, we are paving the way for research and technology development in the biosimilars and biopharmaceuticals sector, a core strength of both organisations. Over the years, we have capitalised on each other’s capabilities to hold joint training sessions and seminars for researchers across biopharma/ biosimilars start-ups and established companies. Recently, CCAMP shared their experience of working with these innovative solutions, underscoring how they are helping them achieve desired results and enhance customer satisfaction. Dr Shadab, a senior scientist at CCAMP, shared his experience in a short video. This video provides a deeper understanding of how Agilent’s solutions are making a significant difference in the field of biopharma.