The workshop was organised in partnership with BIRAC and supported by TEQIP III
Institute of Chemical Technology (ICT) recently hosted a five-day, hands-on-training workshop on biosimilars/biologics characterisation. The workshop was organised in partnership with Biotechnology Industry Research Assistance Council (BIRAC) and supported by TEQIP III (Technical Education Quality Improvement Program) III.
Dr Ratnesh Jain, Assistant Professor in Engineering Sciences, ICT, explained the complexity of biopharmaceuticals consisting of biological entities such as recombinant therapeutic proteins, vaccines, mAbs, etc., unlike small molecule-based pharmaceuticals. He also highlighted their structural heterogeneity and the influence of variations in upstream and downstream processes on the biopharmaceutical product.
Further he added, that the methods for biophysical characterisation of the biologics, if propagated to the industrial sector and academic institutes, will help to ensure safety and efficacy of these products and that adequate knowledge of the characterisation techniques was the base of establishing similarity of biosimilars to the innovator products. He has announced that ICT is shortly initiating establishment of integrative biopharma facility to support growing biopharma industry.
Brainstorming lectures were delivered by esteemed keynote speakers from Zumutor Biologics, Lupin, BioCognate Life Sciences, Biocon, Syngene International, as well as academic research institutes such as IISc, Bangalore, BARC and CSIR-IMTECH, Chandigarh. Participants of the workshop involved a diverse population of candidates from academic institutes and industries, as well as students, who provided an excellent opportunity for interdisciplinary interactions and collaborations.
Kavitha Iyer Rodrigues, Guest of Honour for the event, showcased rapid growth of biosimilars in today’s world and emphasised on the regulations involved, revealing real-time facts and figures of this industry.
Dr Samir Kulkarni, one of the keynote speakers for the event and Founder, Biocognate Life Sciences and Dr Abhhishek Kulshreshtha from Biocon described the process development aspects of biosimilar development and regulatory aspects respectively. Dr Sanjeev Gupta from IPCA Laboratories and Shalini Sharma from USV, highlighted process-based and analytical approaches to be considered in controlling aggregate formation during mAb development.
Dr Dhananjay Patankar from Syngene International, presented the know-how of the Indian biopharma industry and provided perspectives for its potential future. He specifically focussed on the need of engineering and technology graduates to biopharma sector. Dr Dhiraj Kumar from BIRAC explained about the upcoming National Biopharma Mission and explained about other funding initiatives from BIRAC, for supporting start-and student ventures.
Size Exclusion Chromatography (SEC), Dynamic Light Scattering (DLS) and Analytical Centrifugation (AUC) were the three bioanalytical methods of focus during the workshop. Associates and sponsors for the workshop from Agilent Technologies and Malvern-Aimil provided support and expertise in conducting hands on training sessions for the participants.