Developing approaches, methods, and techniques to make biotherapeutics cheaper and safer.

Bioprocess Intensification

Bioprocess intensification refers to producing more biologics per unit of time, cost, footprint, and volume. Significant intensification can be achieved by both (i) small specific changes to the current development and manufacturing procedures and processes and (ii) more considerable disruptive changes that incorporate developing and implementing novel technologies.

Biopharma 4.0

The biopharmaceutical industry is undergoing a digital transformation by incorporating tools and techniques that enable efficient data-driven decision-making across various biopharmaceutical discovery, development, and manufacturing activities. By adopting 4.0 technologies, biopharma companies can accelerate drug discovery and development, increase productivity and enhance regulatory compliance through effective process control, ultimately reducing costs and time associated with biologics development and manufacturing.

Continuous Bioprocessing

Switching from batch manufacturing to continuous enables a significant reduction in footprint, ultimately resulting in lower manufacturing costs. Continuous manufacturing processes can be scaled up quickly, based on the operation time, compared to batch processes that require volume-based scale-up. The smaller footprint, lower costs, and faster scale-up of continuous biomanufacturing enable biotherapeutics to be produced at a ‘pandemic pace’ and be accessible to low-income countries.

Publications

  1. Harshit Agarwal, Xiaozhou Wang, Nikki Raju Kulkarni, Sile Tao, Chris Demers. Application of machine learning in ensuring viral safety of biotherapeutics: Case study demonstrating prediction and optimization of viral clearance performance of anion exchange chromatography Current Research in Biotechnology, 2023.
  2. Harshit Agarwal, Capucine Thwin, Bala Thangaraj Kumaar. Single‐use centrifugal separator enables intensification of the clarification process in biomanufacturing of recombinant proteins Journal of Chemical Technology & Biotechnology, 2023.
  3. Agarwal, H., Quinn, L.J., Walter, S.C., Polaske, T.J., Chang, D.H., Palecek, S.P., Blackwell, H.E., Lynn, D.M.. Slippery Antifouling Polymer Coatings Fabricated Entirely from Biodegradable and Biocompatible Components ACS Applied Materials and Interfaces, 2022.
  4. Agarwal, H., Breining, W.M., Lynn, D.M.. Continuous Fabrication of Slippery Liquid-Infused Coatings on Rolls of Flexible Materials ACS Applied Polymer Materials, 2022.
  5. Agarwal, H., Breining, W.M., Sánchez-Velázquez, G., Lynn, D.M.. Reactive Multilayers and Coatings Fabricated by Spray Assembly: Influence of Polymer Structure and Process Parameters on Multiscale Structure and Interfacial Properties Chemistry of Materials, 2022.
  6. Agarwal, H., Polaske, T.J., Sánchez-Velázquez, G., Blackwell, H.E., Lynn, D.M.. Slippery nanoemulsion-infused porous surfaces (SNIPS): Anti-fouling coatings that can host and sustain the release of water-soluble agents Chemical Communications, 2021.
  7. Agarwal, H., Nyffeler, K.E., Blackwell, H.E., Lynn, D.M.. Fabrication of Slippery Liquid-Infused Coatings in Flexible Narrow-Bore Tubing ACS Applied Materials and Interfaces, 2021.
  8. Harshit Agarwal, Kayleigh E. Nyffeler, Uttam Manna, Helen E. Blackwell, David M. Lynn. Liquid Crystal-Infused Porous Polymer Surfaces: A “Slippery” Soft Material Platform for the Naked-Eye Detection and Discrimination of Amphiphilic Species ACS Applied Materials & Interfaces, 2021.
  9. Nikhil Kateja, Harshit Agarwal, Vishwanath Hebbi, Anurag S. Rathore. Integrated continuous processing of proteins expressed as inclusion bodies: GCSF as a case study Biotechnology Progress, 2017.
  10. Nikhil Kateja, Harshit Agarwal, Aditya Saraswat, Manish Bhat, Anurag S. Rathore. Continuous precipitation of process related impurities from clarified cell culture supernatant using a novel coiled flow inversion reactor (CFIR) Biotechnology Journal, 2016.
  11. Abhishek Kumar Sharma, Harshit Agarwal, Mili Pathak, Krishna D.P. Nigam, Anurag S. Rathore. Continuous refolding of a biotech therapeutic in a novel Coiled Flow Inverter Reactor Chemical Engineering Science, 2016.
  12. Harshit Agarwal, Anurag S. Rathore, Sandeep Ramesh Hadpe, Solomon J. Alva. Artificial neural network (ANN)-based prediction of depth filter loading capacity for filter sizing Biotechnology Progress, 2016.
  13. Rathore, A., Kateja, N., Agarwal, H., Sharma, A.K.. Continuous processing for the production of biopharmaceuticals BioPharm International, 2016.
  14. Anurag S. Rathore, Harshit Agarwal, Abhishek Kumar Sharma, Mili Pathak, S. Muthukumar. Continuous Processing for Production of Biopharmaceuticals Preparative Biochemistry and Biotechnology, 2015.
  15. Liquid Crystal-Infused Porous Polymer Surfaces: A Slippery Soft Material Platform for the Naked-Eye Detection and Discrimination of Amphiphilic Species
  16. Liquid Crystal-Infused Porous Polymer Surfaces: A Slippery Soft Material Platform for the Naked-Eye Detection and Discrimination of Amphiphilic Species

Patents

  1. Harshit Agarwal. Slippery liquid-infused porous surfaces that release hydrophilic and hydrophobic agents
  2. Harshit Agarwal. Slippery and Anti-Fouling Liquid-Infused Coatings Fabricated from Biodegradable and Biocompatible Components
  3. Harshit Agarwal. Liquid crystal-infused slippery anti-fouling surfaces
  4. Harshit Agarwal. A coiled flow inverter reactor for continuous refolding of denatured recombinant proteins and other mixing operations