About
Dr
Aswathy Balakrishnan
Postdoctoral Researcher
NIBRT
Dr. Aswathy is a Postdoctoral Research Scientist based at the National Institute for Bioprocessing Research and Training (NIBRT). She completed her PhD in Chemical and Bioprocess Engineering through the EPSRC–Research Ireland Centre for Doctoral Training in Transformative Pharmaceutical Technologies (CDT-TPT), a collaborative programme between NIBRT and University College Dublin (UCD). Her doctoral research focused on the formulation and stability of mRNA and mRNA-lipid nanoparticles. Dr. Aswathy also holds a Master’s degree in Biopharmaceutical Engineering from UCD (2020) and a Bachelor’s degree in Chemical Engineering from the Vellore Institute of Technology, India (2019). Her research interests include in the lyophilisation (freeze-drying) and stability analysis of biologics.
Technical Summary
This project focuses on the optimisation and control of lyophilisation in biopharmaceutical manufacturing through digitalisation. Lyophilisation, or freeze-drying is the process of converting liquid products into powder by drying under frozen and vacuum conditions. Powdered formulations are widely known to improve stability by increasing interactions with excipients and reducing interactions with water molecules. This results in increased shelf life and stability at higher temperatures, making long-term storage and transportation easier. Lyophilisation consists of three main steps – (i) freezing, (ii) primary drying (removal of free water by sublimation) and (iii) secondary drying (removal of bound water by absorption). The integrity of the lyophilised product depends on various factors including temperature, pressure, concentration of the formulation, type and concentration of excipient used, vial size, vial position and liquid fill volume among others.
Lyophilisation is currently a batch-type process that requires trial and error to optimise; however, this is time consuming and wasteful. This project aims to digitise the process, using AI and modelling to simulate the cycle, focusing on the primary drying step. A digital twin of the lyophilisation cycle will be developed in order to potentially predict failures and provide optimum parameters such as temperature, pressure and primary drying time for improved efficiency of the process.