"New medicines/therapies being developed by the pharmaceutical industry and research organizations are increasingly based on some type of biological (rather than chemical) substance, e.g. a large molecule like a protein rather than a small molecule like aspirin. These substances, known collectively as biopharmaceuticals, are significantly more complex to develop and manufacture as a stable and efficacious product than their chemical counter-parts. This increases the demand for new knowledge and understanding to enable the development of these products (for example the composition or formulation of the product) and the associated commercial manufacturing process. Progress in developing new methods and instrumentation which are tailored specifically to the concurrent design of product and process, has been constrained largely by the relatively small market for such instruments and the significant investment that is required to, first test their feasibility, and then develop into a fully validated market offering. The aim of this project is to test the feasibility for developing a new instrument, that has the potential for further development into a high throughput screening tool that will provide the new knowledge required to accelerate and de-risk the development of new product in the fast developing markets for biopharmaceutical, while presenting a unique opportunity for SMEs in the CRO sector and Research Organizations to increase market share and create opportunities for high-skilled employment in this sector."

The AtlasBio (Ref. 102610) was conceived in response to the government's Innovate UK funding competition "Analytical Technologies for Biopharmaceuticals". The project aims to develop a multiplexed suite of process analytical technologies (based on Raman, near infrared and impedance spectroscopy) which support the freeze drying of biologics from the scale-up of batch freeze-drying to the development and implementation of new continuous freeze-drying methods. Our partners are GEA Process Engineering (LEAD), The Centre for Process Engineering, the National Institute for Biological Standards and Control, IS Instruments Ltd, Blue Frog Design Ltd, Ocean Optics UK, OncoLytika Ltd, De Montfort University and Nottingham University.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.

BioStart aim is to produce lyophilised protein formulations that are stable at room temperature and which reconstitute without compromising product quality (esp. aggregation). Stability at room temperature will extend shelf life and reduce the cold chain costs of refrigerated transportation and storage. Current methods for the development of protein formulations for subsequent lyophilization are largely empirical with little understanding of the mechanistic relationships between the characteristics of the protein and the impact of formulation (esp. electrostatic parameters which influence the protein structure and aggregation state) in relation to the physical changes that occur on freeze-thawing and freeze-drying. THE INVENTIVE STEP in the Bio-StaRT programme is the development and implementation of a number of advanced measurement technologies that integrate microscale down strategies for formulation screening (based on fluorescence, midIR and NIR microwell analysis) with new methods (LyoDEA) for the development of process understanding in order to increase the success rate for developing room temperature stable biopharmaceuticals.