An international e-Conference on “Biologics in Healthcare 2021: Unfolding Gene to proteins” was organised by LM College of Pharmacy, Ahmedabad jointly with Gujarat State Biotechnology Mission (GSBTM)-DST in association with ThermoFisher Scientific as Industrial Partner from Feb 4-7, 2021. It covered subjects pertaining to development, characterisation, formulation, manufacturing, data analytics and therapeutics of biological products, besides some distinctive subjects like vaccine development for Covid-19, clone development for new therapeutic agents, insulin analogues, cancer bio-therapeutics and personalised medicines. A plethora of speakers from biotech companies and universities in the US and India shared their expert knowledge and experience on current biologics under development all over the world with a specific target on R&D.
Dr Mukul Jain, the Chief Guest conveyed that the global biologics market is growing due to awareness of biologics’ benefits together with an increasing prevalence of chronic diseases such as cancer, diabetes and arthritis. He held that the pharmaceutical industry is currently facing many changes both within India and globally in respect of research and manufacture of biologics. Prof A H Kalro, Academic advisor to Ahmedabad Education Society, speaking as a guest of honour, conveyed that the healthcare industry needs to do a lot more for our society and held that newly evolving medicines are more biological in nature due to a better understanding of genomes and disease process. Prof Mahesh Chhabria, Principal of the host institute, B M Shah, trustee of Ahmedabad Education Society and Dr Yamini Shah, Organizing Secretary also addressed the audience.
Dr Shardul Salunkhe, AGM & Head, Clone Development and Evaluation Team, Intas Pharmaceuticals (Biopharma), Ahmedabad talked about the basics of clone and cell line development for Biosimilar projects.
Prof Sarfaraz Niazi, Innovative affordable medicines, PharmscikaryoBioAdelloBio. Deerfield, Illinois, US discussed how the COVID crisis has resulted in the paradigm shift in biological research through the use of mRNA vaccines. He described the current generation of biologics like recombinant proteins, cytokines, pegylated protein, antibodies and antibody-drug conjugated while the next generation will be focused on non-natural amino acids, nanobodies, bispecific antibodies and new scaffolds.
A panel discussion centred on current biologics was moderated by Vivek P Chavda, Assistant Professor at the host institute. Dr Arunkuma Ramteke, Ex. Joint Drugs Controller, CDSCO, Dr Sridevi Khambhampaty, Vice President and Head R&D, Biosimilar Development, Intas Pharmaceutical, Dhaval Trivedi, Associate General Manager, Syngene International and Dr Shivprakash Rathnam, CEO, Synchron Research Services shared their expert views during this discussion.
Dr Kapil Maithal, President, Vaccines and Diagnostics at Zydus Cadila Healthcare talked about vaccines in general and dwelt on different platform technologies that are used for developing Covid 19 vaccines and various market players involved in this field.
Dr Ramteke spoke on the regulatory strategies and clinical requirements for the successful development of biologics.
Dr Alejandro Becerra, Principal Applications Scientist at Thermo Fisher Scientific informed about chromatographic applications for the purification of monoclonal antibodies, AAV, and other biotherapeutics, with a focus on affinity chromatography, a highly scalable method.
Dr Nitesh Dave, Consultant for Biopharmaceutical Development, Bangalore, India gave a kaleidoscopic view of progress in insulin therapy from animal insulin to recombinant DNA technology derived human insulin preparations available in the early 1980s tolispro to achieve improved glycemic control without an increase in hypoglycaemic events. Two new insulin analogues, insulin glargine and insulin aspart, have recently been approved for clinical use in the US and several other analogues are being intensively tested.
Dr Ashok Mishra, head downstream processing at Lupin (Biopharma Division), Pune talked about robust downstream processing that requires careful evaluation to deliver a safe, efficacious, consistent and economical product.
Dr Lakshmikanth Gandikota, VP, Innovation Science and Technology, Intas Pharmaceuticals (Biopharma Division), Ahmedabad, India talked about ‘Gene Therapy for HemophiliaA’.
Dr Nidhi Shah, a Medical Geneticist at Harvard Medical School, US gave details about the therapeutic continuum in genetic disorders amalgamating therapy, management and prevention. There is an interconnection of enzymatic defects and non-enzymatic defects for the genetic disorders which can be managed by considering both the factors while designing a therapeutic regimen around it.
Dr Amaranth Chatterjee, head, analytical development at Syngene international, Bangalore talked about the biophysical characterisation of novel biologics and biosimilar products and held that the biophysical behaviour of proteins can impact many aspects of biologic drug function, activity and stability.
Rishabh Mishra, working as an upstream development scientist at Alvotech, Iceland explained the implementation of QbD elements for the successful upstream process development and emphasised on scale-down model development and media optimisation for the cell culture process.
Dr Parth Shah working as Fellow-Hematology and Oncology, Dartmouth-Hitchcock Geisel School of Medicine at Dartmouth, Massachusetts, US elaborated on CAR-T cell therapy in which a patient’s T cells (a type of immune system cell) taken from blood are changed in the laboratory so they will attack cancer cells.
Dr John F Carpenter, professor at University of Colorado, USA and expert member in USFDA and USP dwelt on the protein formulation stability aspect. He explained how the aggregation of protein occurs due to interfacial interaction and how freeze-thaw and surfactants affect stability.
The four-day international e Conference concluded on Feb 7, 2021. The Chief Guest, Dr Anasuya Lahiry Bhadalkar, Joint Director HRD, GSBTM held that the Conference encompassed all subjects for formulating an idea into a biopharmaceutical product and was a very good example of industry-academia interaction. She appealed to all aspirants to explore the National Biopharma Mission instituted by the Department of Biotechnology, DST- Innovate in India for empowering biotech entrepreneurs and accelerating inclusive innovation. She also advised all to avail of special training courses and other facilities offered by the National Facility for Biopharmaceuticals Training Centre in Mumbai.
Dr Mahesh Chhabria, Convener and Dr Yamini Shah, Organizing Secretary summed up the important events, important take-home messages and profusely thanked all valued speakers, sponsors, members of the organising committee and participants.