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Professor Geoff Smith

Job: Professor of Pharmaceutical Process Analytical Technology

Faculty: Health and Life Sciences

School/department: Leicester School of Pharmacy

Research group(s): Pharmaceutical Technologies

Address: De Montfort University, The Gateway, Leicester, LE1 9BH.

T: +44 (0)116 250 6298

E: gsmith02@dmu.ac.uk

W: https://www.dmu.ac.uk/pharmaceutical

Social Media: uk.linkedin.com/in/gsmith02

 

Personal profile

Geoff Smith graduated in Pharmacy from the University of Bath in 1985 and obtained his PhD from the University of Brighton in 1991 based on a study of the mechanisms of action of cryoprotectants. It was then that he developed a keen interest in the dielectric properties of materials.

He joined De Montfort University in 1993 and went on to develop a number of lines of research based around broad band dielectric measurements. In recent years these studies are focussed increasingly on PAT applications in process development and manufacturing controls for the pharmaceutical industry. His research group is now working on a number of pharmaceutical applications for impedance, dielectric and terahertz spectroscopy alongside optical techniques such as laser speckle and optical flow. These techniques cover an extremely wide range of frequencies thereby enabling the direct analysis of material properties over a wide range of scales from the macroscopic to the molecular.

He was responsible for the development of through-vial impedance spectroscopy (LyoDEA) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), temperatures, and drying profiles and end points, in collaboration with GEA Pharma Systems and AstraZeneca (Funded by the Technology Strategy Board).

More recently his pharmaceutical research focus has extended to investigations into the use of electrostatic noise measurements and optical imaging for applications in roller compaction, powder flow and tablet defect analysis, with the aim of improving understanding and control of tablet production methods. Through his 2015 DIRECT programme he has shaped an industry based collaboration of companies to develop improved methods for materials selection for direct compression tableting, coupled to optimised engineering solutions and DMU's novel process senors, to transform DC into a versatile, flexible manufacturing process capable of processing more drug candidates.

In the medical field he has developed research projects into applications for THz imaging for diagnosing melanoma with Leicester Royal Infirmary (funded by Hope Against Cancer).

From 2007 he began to re-structure the Pharmaceutical Technologies group, by recruiting staff from various backgrounds, including chemists, physicists, chemical engineers and process control specialists in order to diversify the research base of the group and to re-focus efforts on current pharmaceutical industry challenges in product design and manufacturing. By 2010 he had instigated De Montfort University's Pharmaceutical Quality by Design programme, with a wide range of industrial practitioners providing webinars on elements of quality by design.

 

Research group affiliations

Pharmaceutical Technologies 

Publications and outputs 

Click here for a full list of Geoff Smith's publications and outputs|.

Key research outputs

Darkwah, J., Smith, G., Ermolina, I. and Mueller-Holtz, M. (2013) A THz spectroscopy method for quantifying the degree of crystallinity in freeze-dried gelatin/amino acid mixtures: An application for the development of rapidly disintegrating tablets. International Journal of Pharmaceutics, 455, (1-2), pp. 357-364

Ermolina, I., Darkwah, J. and Smith, G. (2013) Characterisation of Crystalline-Amorphous Blends of Sucrose with Terahertz-Pulsed Spectroscopy: the Development of a Prediction Technique for Estimating the Degree of Crystallinity with Partial Least Squares Regression. AAPS PharmSciTech, online first

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

Smith, G., Arshad, M.A., Polygalov, E., Irina Ermolina, I. (2013) 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, online first

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

Smith, G., Polygalov, E. & Page, T. (2011) A method for monitoring and/or controlling process parameters of a lyophilisation process. British patent application 2480299. Application Number 1007961.4. Filing date 12.05.2010

Research interests/expertise

  • Pharmaceutical processing (tableting, micronization, freeze-drying process development)
  • Process analytical technologies (novel sensors in process understanding and control)
  • Impedance spectroscopy, dielectric spectroscopy, terahertz spectroscopy and terahertz imaging
  • Amorphous materials characterization and stability
  • See current PhD projects for more information.

Areas of teaching

  • Pharmaceutical Sciences
  • Good Manufacturing Practice
  • Pharmaceutical Quality by Design
  • Freeze-Drying
  • Preformulation

Qualifications

  • PhD. Mechanimsof Action of Cryoprotectant 1991 (recipient of the Patani Gold Medal)
  • BPharm 1985 University of Bath

Courses taught

  • BSc Pharmaceutical and Cosmetic Sciences
  • MSc Pharmaceutical Quality by Design

Membership of external committees

Academy of Pharmaceutical Sciences Focus Group: Process Engineering and Product Formulation. Committee member from November 2012 

Academy of Pharmaceutical Sciences Focus Group: Parenterals. Committee member from January 2014

Membership of professional associations and societies

Academy of Pharmaceutical Sciences

Projects

BioStart. A Collaborative R&D programme funded by the Technology Strategy Board aimed at improving the stability of biopharmaceuticals through the developmen tof novel process analytical technologies for microscale down (formulation scrrening) and scale up (process development).

DIRECT. A Collaborative R&D programme aimed at developing material screening technologies, engineering solutions and process analytical science for the implementation of direct compression tableting processes.

Forthcoming events

“Process Analytical Technology and the Question of Scale” Invited talk at the ISL-FD 2015 International Society of Lyophilization – Freeze Drying Conference and Seminar, College of Pharmacy, Barcelona, 6-10 July 2015 http://islyophilization.org/2015-barcelona/|

“Through vial impedance spectroscopy as a tool for the concurrent development of the freeze-drying process and product” Invited talk at the SMi Group 3rd Annual UK Conference on Lyophilisation; Protecting Drug stability and Optimising Formulation Development through Robust PAT and QbD Principles. Holiday Inn Regents Park Hotel, Central London, UK, 29th -30th June 2015

 “PAT in the freeze drying of parenteral products” Invited talk at the Lyophilisation and Freeze Drying USA Conference, Renaissance Woodbridge Hotel, Iselin, New Jersey, USA April 29th & 30th 2015

 

Conference attendance

Seker, H., Uslan, V., Orun, A., Goodyer, E. Smith, G. (2014) Prediction of skin ages by means of multi-spectral light sources, 36th Annual International IEEE EMBS Conference., Chicago 26-30 August, 2014, USA.

Orun, A., Seker, H., Goodyer, E.N., Smith, G, Uslan, V.  (2014) An improvement of skin aging assessment by non-invasive laser speckle effect:  A comparative texture analysis. 2nd International Conference on Biomedical and Health Informatics, BHI2014, Valencia, Spain, 2014

Arshad, M.S. Smith, G., Polygalov, E., Ermolina, I., Page, T., Taylor, J., Birkmire, A., (2014). An application of through vial impedance spectroscopy (TVIS) as a temperature measurement system during freeze drying: the example of lactose 3% w/v solution. AAPS annual meeting and Exposition. San Diego. November 2014

Arshad, M.S. Smith, G., Polygalov, E., Ermolina, I. Mudhar, K., Page, T., Taylor, J., Birkmire, A., (2013). In situ characterization of phase separation in PVP/dextran solution using Impedance spectroscopy. AAPS Annual Meeting and Exposition. San Diego. November 2013

Hussain, A., Ermolina, I., Bukhari, N.I., Smith, G.,  Study of Changes in Crystallinity of Ball Milled Mefenamic Acid using Terahertz Pulsed Spectroscopy. APS UK PharmSci 2014, the Science of Medicines, Weston Auditorium Hertfordshire University, Hatfield UK, 8 - 10 September 2014.

Hussain, A., Ermolina, I., Bukhari, N.I., Smith, G., Quantification of Residual Crystallinity of ball milled anhydrous lactose using DSC and terahertz spectroscopy. 11th European Symposium of Thermal Analysis and Calorimetry, Dipoli Congress Centre, Espoo Finland 17 - 21 August 2014.

Arshad, M.S. Smith, G., Polygalov, E., Ermolina, I. (2014).  In-situ characterization of phase changes in lysozyme/trehalose solutions using through vial impedance spectroscopy. APS UK PharmSci 2014, the Science of Medicines, Weston Auditorium Hertfordshire University, Hatfield UK, 8 - 10 September 2014 (podium presentation)

Arshad, M.S., Polygalov, E., Ermolina, I., Smith, G. (2013). Study on the impact of annealing on the primary drying times using impedance spectroscopy. UKPharmSci2013 Edinburgh, September 2nd - 4th 2013

Hussain, A.,  Ermolina, I., Bukhari, N.I.,  Khan, K.A., Smith, G. (2013) Milling and co-milling with various excipients for the improvement of intrinsic dissolution rate of ibuprofen. UKPharmSci2013 Edinburgh, September 2nd - 4th 2013

Arshad, M.S., Mahboubian, A., Stolnik, S., Marlow, M.E., Ermolina, I., Smith, G. (2012) Evaluation of Thermo-Gelation by Impedance Spectroscopy. The Science of Medicines. Academy of Pharmaceutical Sciences Annual Conference. East Midlands Conference Centre. Nottingham. September 12-14th 2012

Hussain, A., Ermolina, I., Bukhari, N.I., Smith, G.(2012) A Study of the Amorphization of Lactose Monohydrate following extended milling times. UK PharmSci 2012, Nottingham, 12th - 14th September 2012

Hussain, A., Ermolina, I., Bukhari, N.I., Smith, G. (2012) Surface percolation of protons for the creation of crystal defects in lactose monohydrate following short milling times. UK PharmSci 2012, Nottingham, 12th-14th September 2012

Marlow, M.E., Seker, H. and Smith, G. (2012) Characterisation of amorphous and crystalline domains using terahertz spectroscopy. The Science of Medicines. Academy of Pharmaceutical Sciences Annual Conference. East Midlands Conference Centre. Nottingham. September 12-14th 2012

Mueller-Holtz, M.  et al. (2012) Assessment of Microneedle Intradermal Penetration Depth using Terahertz Pulsed Imaging. The Science of Medicines. Academy of Pharmaceutical Sciences Annual Conference. East Midlands Conference Centre. Nottingham. September 12-14th 2012

MahboubianA, Stolnik S, Arshad MS, Marlow M, Smith G. Novel methods for evaluating in-situ gelation using terahertz and dielectric spectroscopy. UKICRS 2012, Aston University, Birmingham, UK, May 2, 2012.

Arshad MS, Ermolina I, Polygalov E, Smith G. In situ impedance measurement of mannitol crystallization during the lyophilisation cycle using LyoDEA™. UK-PharmSci, Nottingham UK, September, 12th -14th 2012.

Arshad MS, Ermolina I, Polygalov E, Smith G. LyoDEA™ measurement of the glass transition of sucrose within a freeze-drying vial. UK-PharmSci, Nottingham UK, September, 12th -14th 2012.

Nazari, K. , Ermolina,  I., Smith, G. (2011). Measuring the base thickness of lyophilisation vials by terahertz pulsed imaging. UKPharmSci2011 Nottingham, August 31st - September 2nd 2011

Darkwah, J., Ermolina,  I. , Smith, G. (2011). Identifying the characteristics of the terahertz absorption spectra of a crystalline binary system containing proline and serine. UKPharmSci2011 Nottingham, August 31st - September 2nd 2011

Wall, L.A. et al. (2011) Evaluating lactose content within Avicel® PH-101 tablets by computational analyses of terahertz waveforms. UKPharmSci2011 Nottingham, August 31st - September 2nd 2011

Smith G, Arshad MS, Ermolina I. Lyosense™. An evaluation of the impact of electrode design on the freezing onset times in the lyophilisation process. UK-PharmSci, Nottingham UK, 31st August- 2nd September 2011.

Darkwah, J., Smith, G. and Ermolina, I. (2010) Terahertz pulsed spectroscopy study of amino acids and gelatin. Journal of Pharmacy and Pharmacology, 62 (10), pp. 1477-1478

Ermolina, I. and Smith, G. (2010) Dielectric spectroscopy of low-losses sugar lyophiles: III. The influence of moisture on the dielectric response of freeze-dried lactose. Journal of Non-Crystalline Solids, 357 (2) pp. 671-676

Ermolina, I., Pandya, A. and Smith, G. (2010) Comparative study of freeze-dried disaccharides by dielectric spectroscopy with respect to molecular mobility and stability. Journal of Pharmacy and Pharmacology, 62 (10), pp. 1409-1410

Nazari, K., Smith, G. and Ermolina, I. (2010) Spatial map of freeze-drier shelf temperature variations using product collapse as a surrogate temperature probe. Journal of Pharmacy and Pharmacology, 62 (10), pp. 1471-1472

Pandya, A., Ermolina, I., Storey, R., Smith, G. (2010) Relationship between ATP hydrolysis and molecular dynamics in co-freeze-dried sugar-ATP mixtures. Journal of Pharmacy and Pharmacology, 62 (10), pp. 1465-1467

Smith, G., Polygalov, E. and Page, T. (2010) Lyosense (TM) Lyophilisation process control. Journal of Pharmacy and Pharmacology, 62 (10), pp. 1448-1449

Wall, L. A., Ermolina, I. , Gamlen,M. J., and Smith, G. (2010) Use of terahertz time-domain spectroscopy to correlate refractive index and hardness for Avicel PH-101 tablets. Journal of Pharmacy and Pharmacology, 62 (10), pp. 1485-1486

Smith, G. (2010). Lyosense™. Lyophilisation process control. PDA Europe conference. Freeze-Drying. Modern Trends in Production.Vienna. November 23-24th 2010

Fei, D., Ermolina, I. and Smith, G. (2009) A study of the degradation of poly(lactic-co-glycolic acid) films by DRS, DSC and SEM. Journal of Pharmacy and Pharmacology, 61 (S1), A91-A92, Meeting abstract 124

Pandya, A. et al. (2009) High-performance liquid chromatography method development for studying the degradation of freeze-dried adenosine triphosphate when stored at 4 and 40 degrees C.  Journal of Pharmacy and Pharmacology, 61 (S1), A130, Meeting Abstract 177

Smith, G. and Ermolina, I. (2009) Dielectric relaxation in freeze-dried disaccharides: developments in our understanding of the potential significance to moisture buffering of freeze-dried products.  Journal of Pharmacy and Pharmacology , 61 pp. A68-A69

Smith, G. and Ermolina, I. (2009). Dielectric relaxation in freeze-dried disaccharides: developments in our understanding of the potential significance to moisture buffering of freeze-dried products. Journal of Pharmacy and Pharmacology 61: A68-A69.

Smith, G. et al. (2009) Measurement of amorphous lactose stability by terahertz spectroscopy. Journal of Pharmacy and Pharmacology, 61 (S1), pp. A3-A4, Podium presentation

Consultancy work

We currently offer our expertise in freeze-drying process development to assist pharmaceutical companies in the development of optimized freeze-drying cycles. Through the application of new process analytical technologies (LyoDEA) we can reduce your development time while delivering a shorter cycle time.

This will reduce the materials consumed in development, accelerate your product to market, and provide you with a more efficient process hence reduce the cost of manufacture.

Current research students

Supervisor

Role

Student

Mode

Funding Source

Smith, Geoff

1st

Sohail Muhammad Arshad

Graduated 2014

University of Lahore & AstraZeneca

Smith, Geoff

2nd

Joseph Darkwah

FT

Self

Smith, Geoff

1st

Amjad Hussain

FT

University of Lahore

Smith, Geoff

1st

Martin Mueller-Holtz

FT

Hope Against Cancer

Smith, Geoff

1st

Amee Pandya

Graduated 2014

AstraZeneca and Agilent

Smith, Geoff

1st

Alex Wall

FT

DMU 2009 Scholarships

Externally funded research grants information

BioStaRT. Biopharmaceutical Syability at Room Temperature. Geoff Smith. Principal Investigator. Technology Strategy Board Grant for Collaborative R&D. June 2014 to May 2017. Collaborators: GEA Pharma Systems, BlueFrog Design, NIBSC, Genzyme Ireland

LyoDEA. In-process sensing technology for control of the freeze-drying cycle. Geoff Smith. Principal Investigator. Technology Strategy Board Grant for Collaborative R&D. Nov 2008 to Oct 2012. Collaborators: GEA Pharma Systems, AstraZeneca, Ametek

Published patents

Smith, G, and Polygalov E. (2007). Apparatus for measuring the dielectric properties of conductive materials. British patent 0704880.4 Filing date 13 March 2007. Publication number GB2447477 17 September 2008

Smith, G., Polygalov, E. and Page, T. (2011) A method for monitoring and/or controlling process parameters of a lyophilisation process. GB patent GB2480299 (A). Application number GB20100007961 20100512. Priority date 12 May 2010. Published 16th November 2011

LyoDEA: Through Vial Impedanace Spectroscopy

The freeze-drying cycle comprise three stages, of pre-freezing (to form ice and to crystallise out any solutes with a propensity to crystallise), primary drying to remove the ice phase, and secondary drying to remove the water which is physic-sorbed to the remaining matrix or crystalline and amorphous solids. Process optimization and scale up requires measurement technologies for characterising each stage of the process. In the freezing stage, it is essential to maximise the amount of ice that forms and to optimise the ice structure in order to facilitate sublimation in the primary drying phase. In primary drying it is essential that the product temperature is as high to reduce the drying time, while maintaining it below certain critical temperatures (e.g. eutectic temperature if the unfrozen phase is largely crystalline and the glass transition if the unfrozen phase is largely amorphous) in order to avoid collapse (from melting and/or loss of structural viscosity.

Process analytical techniques for achieving these challenges goals are limited. Thermocouples are used primary for the detection of crystallization (primary phase transitions) but are ineffective at detecting the glass transition and collapse. Pressure rise testing is used in primary drying, and through modelling of the system can be used to control the temperature at the sublimation interface, and hence optimise the drying process. However, the thermocouple is invasive and may itself alter the ice crystal structure (and hence drying profile), whereas the pressure rise testing model relies on many assumptions in the model which provides an average batch measurement across the drier, and only works in the early phase of drying when there is a steady state condition.

The Pharmaceutical Technologies Group has developed a new approach for process understanding for freeze-drying cycle development, which uses a through vial impedance measurement (LyoDEA) to characterise a broad range of features of the process, including, ice onset times, the completion of ice solidification, the glass transition, and the structural relaxation of the unfrozen solid, and the primary drying rate and end point. The on-going development of this technology will see the application with micro-titre plate technologies for formulation screening (micro-scale down) and for scale up into production by using a non-contact probes for monitoring problematic regions within the drier.

 Key References

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. Eur J Pharm Biopharm., 87, (3), pp. 598-605

Smith, G.; Arshad, Muhammad Sohail; 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. J Pharm. Sci., 103, (6), 1799-1810

Smith, G., Arshad, M.A., Polygalov, E., Ermolina, I. (2013) 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, online first

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

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

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

Smith, G., Polygalov, E. & Page, T. (2011) A method for monitoring and/or controlling process parameters of a lyophilisation process. British patent application 2480299. Application Number 1007961.4. Filing date 12.05.2010

 

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