We are dedicated to creating best practices that facilitate successful Commercialization of Biotech Products. Our focus is on activities in process development and manufacturing that would result in production of safe and efficacious drugs utilizing robust, efficient and economical processes. We plan to achieve this by actively collaborating with the regulatory agencies, the biotech industry and academia.
Core Areas of Interest
Quality by Design (QbD)
Process Analytical Technology (PAT)
Multivariate Data Analysis (MVDA)
Computational Fluid Dynamics (CFD)
High-Throughput Process Development (HTPD)
Adaptive control of bioreactors
Aggregation of biotech therapeutics
Development and commercialization of purification and analytical technologies
Development, scale-up, technology transfer, validation, and monitoring of biotech processes
Modeling of biotech unit operations
Characterization of biosimilar products
Scientific and regulatory issues around approval of biosimilars
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