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Publications

Book Chapters   |   PhD theses   |   Journal Articles   |   Podium Presentations   |   Poster Presentations

Book Chapters

Smith, G. & Jeeraruangrattana, Y. 2019, "Chapter 5 Through-Vial Impedance Spectroscopy (TVIS): A New Method for Determining the Ice Nucleation Temperature and the Solidification End Point" in Freeze Drying of Pharmaceutical Products, eds. D. Fissore, R. Pisano & A. Barresi, 1st edn, CRC Press, Florida, United States, pp. 77-98. E-book published 24^th October 2019 doi.org/10.1201/9780429022074-5. Access via  & 

Smith, G. & Polygalov, E. 2019, "Chapter 11 Through vial impedance spectroscopy (TVIS): A novel approach to process understanding for freeze-drying cycle development" in Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches, eds. K.R. Ward & P. Matejtschuk, 1st edn, Humana Press, New York, pp. 241-290. Access via  & 

MPhil and PhD theses

Vadesa, A. (2022). The development of micro-sample electrical impedance analysis for freeze-drying process development . PhD Thesis, ̨ÍåÂãÁÄÖ±²¥, Leicester 

Ogogua, L. (2021). Pharmaceutical instrumentation development for in-process monitoring of freeze-drying cycles. PhD Thesis, ̨ÍåÂãÁÄÖ±²¥, Leicester 

Jeeraruangrattana Y. (2020) Applications for Through-Vial Impedance Spectroscopy (TVIS) in the Development of Pharmaceutical Freeze-Drying Processes. PhD Thesis, ̨ÍåÂãÁÄÖ±²¥, Leicester. https://www.dora.dmu.ac.uk/handle/2086/20278

Pandya B. (2020) Single Vial Monitoring of Pharmaceutical Freeze Drying Processes using Through Vial Impedance Spectroscopy. PhD Thesis, ̨ÍåÂãÁÄÖ±²¥, Leicester.

Arshad, M.S. (2014). Application of Through-Vial Impedance Spectroscopy as a Novel Process Analytical Technology for Freeze Drying. PhD Thesis, ̨ÍåÂãÁÄÖ±²¥, Leicester.

Suherman, P.M. (2001) A Novel Dielectric Technique for Monitoring the Lyophilization of Globular Proteins. PhD Thesis, ̨ÍåÂãÁÄÖ±²¥, Leicester. 

Journal Articles

Pandya, B., Smith, G., Ermolina, I., Polygalov, E. (2021). Observations on the changing shape of the ice mass and the determination of the sublimation end point in freeze-drying: An application for through-vial impedance spectroscopy (TVIS). Pharmaceutics, 13(11) 1835. Accepted 13 October 2021, Available online 02 November 2021 . Access via and

Jeeraruangrattana, Y., Smith, G., Polygalov, E. and Ermolina, I. (2020) Determination of ice interface temperature, sublimation rate and the dried product resistance, and its application in the assessment of microcollapse using through-vial impedance spectroscopy. European Journal of Pharmaceutics and Biopharmaceutics, 152, pp. 144-163 Accepted 22 April 2020, Available online 28 April 2020 . Access via &

Smith, G., Jeeraruangrattana, Y., Ermolina, I. (2018). The application of dual-electrode through vial impedance spectroscopy for the determination of ice interface temperatures, primary drying rate and vial heat transfer coefficient in lyophilization process development. European Journal of Pharmaceutics and Biopharmaceutics, 130, pp. 224-235, accepted 17 May 2018, available online 27 June 2018 . Access via & researchgate

Smith, G., Arshad, M.S., Polygalov, E., Ermolina, I., McCoy, T.R., Matejtschuk, P. (2017). Process Understanding in Freeze-Drying Cycle Development: Applications for Through-Vial Impedance Spectroscopy (TVIS) in Mini-pilot Studies. Journal of Pharmaceutical Innovation, 12 (1), pp. 26-40. First Online: 26 November 2016.   Access via  & 

Arshad, M.S., Smith, G., Polygalov, E., Ermolina, I. (2014). Through-vial impedance spectroscopy of critical events during the freezing stage of the lyophilization cycle: The example of the impact of sucrose on the crystallization of mannitol. European Journal of Pharmaceutics and Biopharmaceutics, 87 (3), pp. 598-605. Accepted 3 May 2014, Available online 10 May 2014  Access via  & researchgate

Smith, G., Arshad, M.S., Polygalov, E., Ermolina, I. (2014). Through-Vial Impedance Spectroscopy of the Mechanisms of Annealing in the Freeze-Drying of Maltodextrin: The Impact of Annealing Hold Time and Temperature on the Primary Drying Rate. Journal of Pharmaceutical Sciences, 103 (6), pp. 1799-1810. Accepted 1 April  2014. Available online 22 April 2014  Access via  & researchgate

Smith, G., Arshad, M.S., Nazari, K., Polygalov, E., Ermolina, I. ; Taylor, J., Page, T. (2014) Through-Vial Impedance Spectroscopy: A New In-Line Process Analytical Technology for Freeze Drying. Pharmaceutical Technology, 38 (4), pp. 38-46. Available online 2 April 2014. Access via  &   & researchgate

Smith, G., Arshad, M.S., Polygalov, E., Irina Ermolina, I. (2014) Factors Affecting the Use of Impedance Spectroscopy in the Characterisation of the Freezing Stage of the Lyophilisation Process: the Impact of Liquid Fill Height in Relation to Electrode Geometry. AAPS PharmSciTech, 15 (2),  pp 261–269. First Online: 05 December 2013  Access via  & researchgate

Smith, G., Arshad, M.S., Polygalov, E. and Ermolina, I. (2013) An application for impedance spectroscopy in the characterisation of the glass transition during the lyophilization cycle: The example of a 10% w/v maltodextrin solution. European Journal of Pharmaceutics and Biopharmaceutics, 86 (3 Part B), pp. 1130-1140. Accepted 5 August  2013, Available online 16 August 2013.  Access via & researchgate

Smith, G., Polygalov, E., Arshad, M.S., Page, T., Taylor, J., Ermolina, I.  (2013) An impedance-based process analytical technology for monitoring the lyophilisation process. International Journal of Pharmaceutics, 449 (1-2), pp. 72-83.Accepted 28 March 2013, Available online 13 April 2013   Access via  &researchgate

Note: DORA stands for ̨ÍåÂãÁÄÖ±²¥ Open Research Archive.

 

Podium Presentations

 

Smith, G. (2022) Where’s the true sublimation end point in primary drying? On-line presentation at Qepler 4^th Lyophilization summit.  16-17 Feb On-line

Smith G (2022) Process analytical technology (PAT) for sublimation end point determination (primary drying stage) On-line presentation at Oxford Global Pharmaceutical Lyophilization Symposium. 8 November 2022 

Smith, G. (2022) The determination of the true sublimation end point by through-vial impedance spectroscopy. Podium presentation at Biotrains Lyotalk Europe. Dublin, 21-22 July 

Smith, G. (2022) What’s the point in the end point? An application for electrical impedance spectroscopy in primary drying. Podium presentation at Biotrains Lyotalk Europe. Amsterdam 19-20 May 2022 

Smith, G. (2022) Freeze-drying for the stabilization of drug products: Recent developments in process analytical technologies. Podium presentation at Oxford Global Formulation and Delivery UK. London 5-6 May 2022 

Smith, G. (2022) Process analytical technology for lyophilization cycle development: Applications for electrical impedance spectroscopy. On-line presentation at Innovatrix Pharmaceutical Processing Summit. 26-27 January 2022.

Smith, G. (2021) Non-invasive impedance spectroscopy for single vial PAT in biopharmaceutical freeze drying. On-line presentation at Pharma Manufacturing Europe. December 1-2, 2021. https://figshare.dmu.ac.uk/account/projects/59717/articles/19625694 (with recording)

Smith, G. (2021) Non-invasive impedance spectroscopy for single-vial PAT in biopharmaceutical freeze-drying. Podium presentation at Oxford Global Formulation and Delivery UK. September 21-23, 2021. https://doi.org/10.21253/DMU.16656988.v1

Smith, G. (2021) An introduction to TVIS PAT. On-line presentation at Qepler Lyophilization Summit, 2021 July 29-30.

Smith, G. (2021) Non-invasive spectroscopic methods for single-vial PAT in biopharmaceutical freeze-drying. On-line presentation at Marcus Evans 12^th Biologics Formulation Development & Drug Delivery Forum, 2021 June 14-15. https://doi.org/10.21253/DMU.14785236

Smith, G. (2021) Applications for Electrical Impedance Spectroscopy Process Analytical Technology (EIS-PAT) in Lyophilization Process Development. On-line presentation at: Volanthen's 2nd Freeze-Drying Technology Summit, 2021 February 17th-18^th.

Smith, G. (2020) Lyophilization Process Development for Biopharmaceuticals: Applications for EISPAT. On-line presentation at 11th Conference on Biologics Formulation Development and Drug Delivery, 2020 October 22-23.

Smith, G. (2020) Z-FDM: Micro-Sample Impedance Spectroscopy for Freeze-Dried Formulation Development. Podium presentation at PDA Europe Virtual Conference - Pharmaceutical Freeze-Drying Technology, 2020 September 24-25, online.

Smith, G. (2020) Impedance Spectroscopy: Recent Developments As a PAT for Pharmaceutical Freeze-Drying. Podium presentation at Oxford Global Bio manufacturing Congress, London, 2020 July 8-9.

Smith, G. (2020) Lyophilization Process Development. Applications for eisPAT. On-line presentation at: Marcus Evans Digital Week Biologicals Formulation Development and Drug Delivery. June 22-26th 2020.

Smith, G. (2020) Novel impedance-spectroscopy PAT for freeze drying process development. KTN meeting. Podium presentation at Analytical challenges & solutions for medicines manufacturing towards Industry 4.0, Centre for Process Innovation, Darlington, 2020 February 26.

Smith, G. (2020) Novel electrical impedance methods in formulation and process development. Podium presentation at Freeze-Drying Technology Summit, Vienna 2020 Feb 13-14.

Smith, G. (2020) Z-FDM : Impedance spectroscopy enhanced freeze drying microscopy. Podium presentation at 2nd Annual Pharmaceutical Lyophilization Summit 12-13 Feb 2020, Berlin.

Smith G, Jeeraruangrattana Y.  Electrical impedance methods for developing a lyophilization cycle. Podium presentation at: ISL-FD 9th International Conference, 2019 September 2nd-6th, Ghent, Belgium.

Vadesa A, Smith G, Horley N, Ward K, Dalby P. Application of a novel impedance-based freeze-drying microscopy for formulation development. Podium presentation at: ISL-FD 9th International Conference, 2019 September 2nd-6th, Ghent, Belgium.

Vadesa A, Smith G, Horley N, Dalby P, Kevin W. Application of a novel impedance-based freeze-drying microscope for formulation development. Podium presentation at: Formulation Solutions for Diversifying Biopharmaceutical Portfolios-Knowledge Transfer Event (Innovate UK), 2019 July 11th, Manchester, UK.

Smith G, Jeeraruangrattana Y. Applications for impedance spectroscopy in the determination of in-vial phase behaviour. Podium presentation at: SMi 7th Annual Lyophilization Conference, 2019 June 3rd - 4th, Holiday Inn Kensington Forum, London, United Kingdom.

Smith G, Jeeraruangrattana Y. Impedance Spectroscopy: Recent developments as a process analytical technology for pharmaceutical freeze-drying. Podium presentation at: Pharmaceutical Lyophilisation Summit, 2019 February 13-14th, Novotel Praha Wenceslas Square Hotel, Prague, Czech Republic.

Smith G. Jeeraruangrattana Y. Multiplex Single Vial Process Analytical Technologies: Through vial impedance spectroscopy (TVIS) and thermocouple temperature sensors. Podium presentation at: Freeze Drying of Pharmaceutical and Biologicals, 2018 September 18th – 21st, Dorint Hotel, Garmisch-Partenkirchen, Germany 

Smith G. Through-Vial Impedance Spectroscopy (TVIS). A new process analytical technology for freeze-drying process development. Podium presentation at: SMi 6th Annual Conference on Pharmaceutical Freeze-Drying Technology, 2018 June 13-14^th, Holiday Inn Kensington Forum, London, United Kingdom [Slides] 

Smith G. Through-Vial Impedance Spectroscopy (TVIS). A novel process analytical technology for the development of pharmaceutical products and processes. Podium presentation at: 2^nd Annual Lyophilization Summit, 2018 May 24-25^th , Vienna, Austria [Slides]

Smith G. Through Vial Impedance Spectroscopy (TVIS): Dual-electrode System for Process Parameter Determination. Podium presentation at:  ISL-FD Midwest Chapter Annual Meeting, April 12^th 2018 Midwest Conference Centre, Northlake, IL 60164, USA [Slides] 

Smith, G. Through Vial Impedance Spectroscopy (TVIS).A novel process analytical technology for the development of freeze drying processes and products. LyoHub, April 10^th 2018 University of Purdue, West Lafayette, USA [Slides]

Smith G. Through vial impedance spectroscopy (TVIS): A Novel Approach in the Development of Freeze-Drying Processes for Drug Products. Podium presentation at: 10th International Workshop on Impedance Spectroscopy, 2017 September 27-29, Chemnitz, Germany [Abstract] [Slides] 

Pandya B, Smith G, Polyglov E, Ermolina I. New impedance based methodologies to determine the vial heat transfer coefficient and the endpoint of primary drying. Poster presentation at: International PharmSci; 2017 Sept 5-7; Hatfield, UK.

Smith G. Applications for through vial impedance spectroscopy (TVIS) in process parameter determination. Podium presentation at: LyoTalk; 2017 May 22-23; Dublin, Ireland. 

Smith G. Recent advances in through vial impedance spectroscopy (TVIS) for process parameter determination. Podium presentation at: ISL-FD Conference; 2017 Apr 26-28; Havana, Cuba. 

Smith, G. (2016) Freeze-drying process optimization using through vial impedance spectroscopy. Podium presentation at EPSRC EHDA Network International Pharmaceutical Technology Conference, November 4, Leicester, United Kingdom. 

Smith G. The application of through vial impedance spectroscopy (TVIS) for process parameter determination in freeze-drying method development. Podium presentation at: PDA Europe. Pharmaceutical Freeze Drying Technology; 2016 Sept 27-28; Strasbourg, France. 

Smith G. Through vial impedance spectroscopy. Podium presentation at: SMi Lyophilisation Europe; 2016 Jul 4-5; London, UK. 

Smith G. Process analytical technology and the question of scale. Podium presentation at: ISL-FD Conference and Seminar; 2015 Jul 8-10; Barcelona. 

Smith G. A focus on PAT in freeze-drying. Podium presentation at: APS Parenteral Focus Group Meeting on Freeze Drying and Alternative Drying Technologies for Parenterals; 2015 Jan 28; Burleigh Court, Loughborough, UK. 

Smith G. LyoDEA™ An impedance-based approach to the development of optimized freeze-drying cycles. Poster presented at: 1st QbD Symposium; 2013 Apr 11; Leicester, UK. [Slides]

Smith G. Lyosense^TM:Lyophilisation process control. Podium presentation at: PDA Europe conference. Freeze-Drying. Modern Trends in Production; 2010 Nov 23-24; Vienna, Austria.

 

Poster Presentations

 

Ogugua L, Smith G, Orun A. The use of through vial impedance spectroscopy (TVIS) for determination of ice nucleation, solidification end point, and mannitol crystallization during freezing and re-heating. Poster presentation at: 10^th APS International PharmSci; 2019 Sept 11-13; Greenwich, UK 

Pandya B, Smith G, Matejtschuk, P, Jeeraruangrattana Y, Ermolina I. Multiplexing through vial impedance spectroscopy (tvis) with comparative pressure measurement. Poster presentation at: ISL-FD 9th International Conference; 2019 Sept 2-6; Ghent, Belgium. 

Jeeraruangrattana Y, Smith G, Ermolina I, Polygalov, E. TVIS: A new approach to characterizing phase transition of sugar-salt solutions. Poster presentation at: ISL-FD 9th International Conference; 2019 Sept 2-6; Ghent, Belgium. 

Vadesa A, Smith G, Horley N, Ward K, Dalby P. Application of a novel impedance-based freeze-drying microscopy for formulation development. Poster presentation at: ISL-FD 9th International Conference; 2019 Sept 2-6; Ghent, Belgium. 

Ogugua L, Smith G, Orun A. Application of through vial impedance spectroscopy (TVIS) for the determination of ice nucleation, solidification endpoint, and mannitol crystallization and melt-back temperature during freezing and annealing. Poster presentation at: ISL-FD 9th International Conference; 2019 Sept 2-6; Ghent, Belgium. 

Vadesa A, Smith G, Horley N, Dalby P, Kevin W. Application of a novel impedance-based freeze-drying microscope for formulation development. Poster presentation at: Formulation Solutions for Diversifying Biopharmaceutical Portfolios-Knowledge Transfer Event (Innovate UK); 2019 Jul 11; Manchester, UK. 

Jeeraruangrattana Y, Ermolina I, Polyglov E, Smith G. Application of impedance based technology to investigate the collapse of freeze-dried sugar-salt solutions. Poster presentation at: Freeze Drying of Pharmaceutical and Biologicals; 2018 Sept 18-21; Garmisch-Partenkirchen, Germany. 

Pandya B, Smith G, Polyglov E, Ermolina I. Application of through vial impedance spectroscopy for lyophilization process development. Poster presentation at: Freeze Drying of Pharmaceuticals and Biologicals; 2018 Sept 18-21; Garmisch-Partenkirchen, Germany. 

Vadesa A, Smith G, Dalby P, Horley N, Polygalov E. Vadesa, Application of through vial impedance spectroscopy to different container. Poster presentation at: Freeze Drying of Pharmaceuticals and Biologicals; 2018 Sept 18-21; Garmisch-Partenkirchen, Germany. 

Jeeraruangrattana Y, Ermolina I, Polygalov E, Smith G. Prediction of the collapse of freeze-dried lactose solution using TVIS. Poster Presentation at: 8th APS International PharmSci Conference; 2017 Sept 5-7, Hatfield, UK. [Abstract] [Poster] 

Pandya B, Smith G, Polyglov E, Ermolina I. New impedance based methodologies to determine the vial heat transfer coefficient and the endpoint of primary drying. Poster presentation at: International PharmSci; 2017 Sept 5-7; Hatfield, UK. 

Jeeraruangrattana Y, Pandya B. Vhokiwa H, Shah S, Smith G. Application of impedance based technology (TVIS) for the prediction of micro-collapse. Poster Presentation at: 5th Quality by Design Symposium; 2017 Mar 29; Leicester, UK. 

Jeeraruangrattana Y, Pandya B. Ermolina I, Smith G. The application of through vial impedance spectroscopy for optimization freeze-drying. Poster Presentation at: International PharmTech; 2016 Nov 4; Leicester, UK. 

Arshad MS, Smith G, Polygalov E, Ermolina I. An application of through vial impedance spectroscopy (TVIS) as a temperature measurement system during freeze drying: The example of lactose 3% w/v solution. Poster presented at: AAPS Annual Meeting and Exposition, 2014 Nov 2-6; San Diego, USA.

Arshad MS, Smith G, Polygalov E, Ermolina I. In-situ characterization of phase changes in lysozyme/trehalose solutions using through vial impedance spectroscopy. Poster presented at: UK-PharmSci; 2014 Sept 8-10; Hatfield, UK.

Arshad MS, Smith G, Polygalov E, Ermolina I. In-situ characterization of phase changes in lysozyme/trehalose solutions using through vial impedance spectroscopy for freeze drying cycle. Poster presented at: Amorph; 2014 Jul 14-16; Cambridge, UK.

Arshad MS, Ermolina I, Polygalov E, Smith G. LyoDEA™ measurement of the glass transition of sucrose within a freeze-drying vial. Poster presented at: UK-PharmSci; 2013 Sept 2-4; Edinburgh, UK.

Arshad MS, Polygalov E, Ermolina I, Smith G. Study on the impact of annealing on the primary drying times using impedance spectroscopy. Poster presented at: UK-PharmSci; 2013 Sept 2-4; Edinburgh, UK.

Arshad MS, Smith G, Polygalov E, Ermolina I, Mudhar K, Page T, Taylor J, Birkmire A. In situ characterization of phase separation in PVP dextran solutions using impedance spectroscopy. Poster presented at: AAPS Annual Meeting and Exposition; 2013 Nov 10-14; San Diego, USA.

Arshad MS, Mahboubian A, Stolnik S, Marlow ME, Smith G. Evaluation of thermo-gelation by impedance spectroscopy. Poster presented at: UK-PharmSci; 2012 Sept 12-14; Nottingham, UK.

Arshad MS, Ermolina I, Polygalov E, Smith G. In situ impedance measurement of mannitol crystallization during the lyophilisation cycle using LyoDEA™. Poster presented at: UK-PharmSci; 2012 Sept 12-14; Nottingham, UK.

Arshad MS, Ermolina I, Polygalov E, Smith G. LyoDEA™ measurement of the glass transition of sucrose within a freeze-drying vial. Poster presented at: UK-PharmSci; 2012 Sept 12-14; Nottingham, UK.

Mahboubian A, Stolnik S, Arshad MS, Marlow M, Smith G. Novel methods for evaluating in-situ gelation using terahertz and dielectric spectroscopy. Poster presented at: UKICRS Drug Delivery Through the Ages; 2012 May 2; Birmingham, UK.

Smith G, Arshad MS, Ermolina I. Lyosense^TM: An evaluation of the impact of electrode design on the freezing onset times in the lyophilisation process. Poster presented at: UK-PharmSci; 2011 Aug 31-Sept 2; Nottingham, UK.

Smith G, Polygalov E, Page T. Lyosense^TM. Lyophilisation process control. Poster presentation at: UK-PharmSci; 2010 Sept 1-3; Nottingham, UK;  available at J Pharm Pharmacol, 62 (10), pp. 1448-1449

Smith G, Polygalov E, Page T. Lyosense^TM: A method for controlling and/or monitoring process parameters of the lyophilization process. Poster presented at: AAPS Annual Meeting and Exposition; 2010 Nov 14-18; New Orleans, USA; Abstract AAPS Journal 12: T2135