Author: jgavira

The aim of this project is to establish a fundamental understanding of relevance of impurities in mAbs crystallisation. Specific objectives: 1-Develop an impurity identification protocol for mAbs using state-of-the-art analytical tools such as LC-MS, MALDI-TOF, etc. The possible source of impurities are error insertion and deletion, unreacted starting materials from the synthetic reaction or fermentation…

The overarching aim of this project is to develop an innovative templating crystallisation platform for peptides. Specific objectives: 1-Investigate feasibility of peptides crystallisation using functionalised nano-templates. Hanging drop assays are performed to screen for crystallisation conditions (e.g., pH, buffer, salt types and concentrations, and nano-templates) using crystallisation robots (e.g., Mosquito). 2-Optimise the crystallisation conditions to…

To develop a technical process strategy decision methodology and assess energy consumption and environmental impact of the developed processes and compare against conventional industrial practise. Specific objectives: 1-Identify key process parameters that affect biomolecules crystallisation kinetics and crystals’ properties. 2- Develop life-cycle assessment (LCA) methods. Initial effort will be based on available information from literature,…

This research focuses on the development of usable instrumentation at the laboratory scale as well as pilot production scale for continuous biomolecules crystallisation. Specific objectives: 1-Training in mAbs and protein (globular proteins) crystallisation: understanding of the process conditions in MOFPRs and investigation in the translation of these data into the present project research. 2-Design and…

To exploit the counter diffusion technique (CDT) to develop new crystallisation screening kits. Specific objectives are: 1-Develop crystallisation kits to widely screening the phase diagram (only CDT can do it) of selected systems (i.e. mAbs), based on the analysis of already published conditions using a ML approach to correlate mAbs general features to their solubility…

Develop a microfluidic platform for high-throughput protein crystallisation experimentation, on a highly instrumented installation (video, Raman and UV spectroscopy, etc.) to collected data on the thermodynamics and kinetics. These data will be shared in the consortium to build mechanistic, statistical and ML models to describe the systems. Specific objectives: 1-Develop a microfluidic platform for crystallization…

This project aims to develop generic, design-oriented process models suitable to describe biomolecules crystallisation in batch and continuous platforms. Specific objectives: 1-Develop a process-level kinetic model library for nucleation and growth of biomolecules: mechanistic models laying on solid physical foundations, and semi-mechanistic models involving fewer parameters. 2-Develop process models that can simulate batch and continuous…

The aim of this project is to deepen our understanding in peptide crystallisation processes, while identifying scalable methodologies tailored for the crystallisation of emerging therapeutic modalities. Specific objectives: 1-Investigate the crystallisability of different fragments of model peptides by high-throughput (HT) screening. 2-Intermediate scale up (100mg-1g scale) of selected crystallisation conditions and initial evaluation as potential…

Explore the use of seeds in a convection free media, i.e. hydrogels, for the mass production of homogenous biomolecules crystals. Selected Phycobiliproteins will be studied. Specific objectives are: 1-Screen and optimise the crystallisation conditions to promote seeds growth while keeping seeds integrity/stability (DSC, TEM, SEM). After the definition of the proper crystallisation mixture (solvent; buffer;…

The present project aims to deliver a unique platform for monoclonal antibodies (mAb) crystallisation based on a modular oscillatory flow plate reactor (MOFPR), with enhanced hydrodynamic and transport properties. Specific objectives: 1-Phase behaviour and solubility curve are assessed for the selected mAbs. 2-Implement design of experiments (DOE) and Response Surface Methodology to identify the process…