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Publications

Publications

Journal Articles

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.  doi.org/10.1007/s12247-016-9266-5 Access via DORA & researchgate

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 doi.org/10.1016/j.ejpb.2014.05.005 Access via DORA & 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 doi.org/10.1002/jps.23982 Access via DORA & 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 Pharmtech.com &  DORA & 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 doi.org/10.1208/s12249-013-0054-y Access via DORA & 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. doi.org/10.1016/j.ejpb.2013.08.004 Access via DORA & 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  doi.org/10.1016/j.ijpharm.2013.03.060 Access via DORA &researchgate

Note : DORA stands for De Montfort University Open Research Archive.

 

Podium Presentations

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, Chemniz, 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. 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, Germany.

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

 

Poster Presentations

Jeeraruangrattana Y, Ermolina I, Smith G. Prediction of the collapse of freeze-dried lactose solution using through vial impedance spectroscopy (TVIS). Poster presented at: International PharmSci; 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.

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. LyosenseTM: 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. LyosenseTM. Lyophilisation process control. Poster presentation at: UK-PharmSci; 2010 Sept 1-3; Nottingham, UK; Abstract available at J Pharm Pharmacol, 62 (10), pp. 1448-1449

Smith G, Polygalov E, Page T. LyosenseTM: 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

 
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