ICT-Mumbai hosts 5 day workshop on biosimilar characterization

The workshop organized by the Institute of Chemical Technology in partnership with Biotechnology Industry Research Assistance Council witnessed extensive five-day training program, involving brainstorming lectures by esteemed keynote speakers

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Mumbai: The Institute of Chemical Technology (ICT) hosted a five-day, hands-on-training workshop on biosimilars/biologics characterization from December 11-15, 2017. The workshop was organized in partnership with Biotechnology Industry Research Assistance Council (BIRAC) and supported by TEQIP III (Technical Education Quality Improvement Program) III. Launch of the most coveted National Biopharma Mission by BIRAC was the source of inspiration for organizing this first-of-its-kind workshop in the country.

As per various reports, the biopharmaceutical market accounts for USD 192.2 million, till the year 2016, and is projected to reach USD 291 billion by 2021. Monoclonal Antibodies (mAbs) and vaccines occupy the largest segments of the global biopharmaceutical market.

As the workshop convener Dr Ratnesh Jain explained the complexity of biopharmaceuticals comprising 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 characterization of the biologics, if propagated to the industrial sector and academic institutes, will help in ensuring safety and efficacy of these products and that adequate knowledge of the characterization techniques was the base of establishing similarity of biosimilars to the innovator products. He has announced that ICT is shortly initiating the establishment of Integrative Biopharmaceutical Facility to support growing biopharmaceutical industry.

Thus, realizing this soaring need, the organizers and ICT structured the extensive five-day training program, involving brainstorming lectures 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 and subject experts from industry and academia. Participants of the workshop also involved a diverse population of candidates from academic institutes and industries, as well as students, which provided an excellent opportunity for interdisciplinary interactions and collaborations.

Ms Kavitha Iyer Rodrigues, guest of honor for the event, showcased rapid growth of biosimilars in today’s world and emphasized 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 of 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 Ms Shalini Sharma from USV Limited highlighted process based and analytical approaches to be considered in controlling aggregate formation during mAb development. Dr Dhananjay Patankar from Syngene International yet another keynote speaker, presented the know-how of the Indian Biopharmaceutical Industry and provided perspectives for its potential future. He has specifically focused on need of engineering and technology graduates to biopharmaceutical sector. Moreover, 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) comprised to be the three bioanalytical methods of focus for 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. Along with hands-on-training in sample preparation, analysis and data interpretation, the workshop organizers also provided practical manuals and handouts relevant to the course for benefit of the trainees.