Industrial Visit at Shilpa Biologicals, Dharwad
The next decade will be ruled by biosimilar or biopharmaceutical products with this consideration the industrial visit was arranged to Shilpa Biologicals, Dharwad. The objective of this visit was to give exposure to M.Pharm, B.Pharm, and Pharm D.students to various processes runs in Biological preparation with evaluation for quality control parameters.
During this visit, various operations were illustrated regarding the development of biosimilar preparations along with their regulatory guidelines. Quality assurance and quality control and documentation processes were shown. Navalbumin, Adalimumab, Aflibercept, and Abatacept biosimilar development plan and their regulating aspects were illustrated in brief. Passbox and receiving of samples throughout the processes were explained. Sputnik vaccine preparation was also illustrated in brief. An in-depth analysis of clinical quality attributes was also explained along with preclinical, clinical pharmacology, and clinical studies. This visit was planned under the guidance of Dean Dr.Shete and coordinated by Asst. Prof. Mr. Waghmode and Asst. Prof. Ms.Anuya Babar.