John Francis Miller
Hillsborough, NC 27278
I leverage the learnings of my 24-year career in the pharmaceutical industry to teach the essential scientific and technical concepts at a level appropriate for the unique needs of each client. I want to dispel the idea that colloid science is complicated, too academic, and challenging to implement. I know that by doing so, my clients will save time and money, and improve the robustness of their products. I apply the skills I developed learning colloid science (my formal discipline) to the resolution of problems in unrelated areas. I use critical visual observation of physical products, processes, and datasets to identify patterns that others fail to see. Such assessment brings about a rapid and inexpensive resolution to complex and costly problems.
CONSULTING AND TRAINING
Do you make business decisions based on understanding the colloid and nanoparticle science or your products or processes? Do you find it too complicated or time-consuming to implement? Are you struggling with seemingly never-ending firefighting or unexpected loss of product quality? I can provide you with the essential tools to increase product and process robustness.
My services can be on-site or remote. I offer training packages that are standard or customized for your needs. Remote training can be live or through e-learning courses. I will quickly increase your level of knowledge that you can put to practical use.
COLLOID AND NANOPARTICLE SCIENCE
Do you make nanoparticle-based products or other colloidal systems such as gels or creams? How comfortable are you with your organization’s understanding of the underlying science? Do you believe it is too complicated or academic? Does your business see little value using it to maximize product quality?
I’ve dealt with real-world colloid and nanoparticle challenges for more than 25 years. I’ve solved problems that stymied companies for months, even years. My solutions save significant time and cost.
I will teach you my skills to address your needs efficiently.
Are you failing to meet major milestones for your product/process development? Are you experiencing random batch failures during manufacturing? Do you fix the underlying problems only to find they come back?
I led the development, submission, and ongoing manufacturing support for GSK’s ADVAIR® HFA Inhalation Aerosol – a billion-dollar blockbuster product. This dosage form is the most complicated and demanding regarding formulation, packaging, and production.
I can help identify failures in the supply chain. I use simple visual observation skills, thorough data analysis, and lateral application of scientific and technical knowledge.
Your problems are complex, demanding, and costly. I can help identify the cause of a problem and recommend a robust remedy. I can help reduce your cost of poor quality and increase the understanding of your products, processes, and how they interact.
Overwhelmed and under-resourced to carried out critical investigations, such as failures during formal stability studies? Or root cause investigations due to significant manufacturing failures? Do you have to compromise experimental designs due to lack of resources? Do politics get in the way of sound investigations?
I design efficient, robust and powerful experiments for applications that include small benchtop studies, method development, stability campaigns, and full-scale manufacturing root cause investigations. I ensure that the designs consider the physical nature of the study, not just idealized textbook designs. I use multiple tools to analyze data, including Microsoft Excel, SAS JMP, and bespoke programs written in Visual Basic and Python. I find patterns in complex data sets that have eluded others and I do so quickly, even for products and processes that I have not encountered before. I can interrogate your data and help establish a way forward with your development and manufacturing challenges.
How important is the measurement of zeta potential for your product development and life-cycle management? How confident are you that your instruments are providing meaningful results for your unique products? What if they might be misleading? What if you make costly wrong decisions as a result?
Would you like to increase your understanding of the role of zeta potential? How about the limitations and misconceptions of its measurement?
I am the inventor and leading authority on the method of choice for modern zeta potential measurement – Phase Analysis Light Scattering (Malvern Panalytical Zetasizer, Nanobrook ZetaPALS, and others). I have deep insight into the practicalities and realities of zeta potential measurement that commercial manufacturers do not. I can provide you with the knowledge needed to efficiently and robustly measure zeta potential so that you can make confident business decisions based on it.
Do you struggle to perform small-scale experiments because essential analytical equipment isn’t available? Are you trying to identify a potential critical quality attribute, but nothing exists to test it? Starting with my invention of Phase Analysis Light Scattering in the late 1980s, I’ve conceived many original instruments. Most are inexpensive surrogates (less than $5,000) for expensive, hard-to-access instruments. Others analyze properties of suspensions, dry powders, pressurized fluids, and more that were considered unmeasurable. Some were intended for early development stage studies. Others were developed into fully-validated GMP methods.
I can work with you to identify opportunities to create inexpensive instruments to gather information otherwise inaccessible. I can also review your existing analytical capabilities and suggests novel ways of using them.
Papers and Oral Presentations
John F. Miller, “Next Generation Electrophoretic Light Scattering”, Oral presentation, ACS National Meeting, Boston, 2018
John F. Miller, “Measuring zeta potential: Black boxes and white elephants”, Oral presentation, 91st ACS Colloid Symposium, Manhattan, 2017
John F. Miller, “Quantitative characterization of powder flow under dynamic conditions”, Oral presentation, AIChE Annual Meeting, Pittsburg, 2012
Miller, John. F., Invited Speaker, “Theory and practice of droplet generation from propellant based inhalers”, Fine Particle Society Symposium, San Diego, 2001
F McNeil-Watson, W Tscharnuter and J Miller, “A New Instrument for the Measurement of Very Small Electrophoretic Mobilities Using Phase Analysis Light Scattering (PALS)”, Colloids and Surfaces A, 140, 53 (1998)
CA Dunbar, AP Watkins and JF Miller, “Characterization of the pMDI spray using numerical methods.”, Proceedings of the International Conference on Liquid Atomization and Spray Systems, 7th, Seoul, Aug. 18-22 1997 (1997), 2 876-883
CA Dunbar, AP Watkins and JF Miller, “Application of laser diagnostic techniques to characterize the spray issued from a pMDI.”, Proceedings of the International Conference on Liquid Atomization and Spray Systems, 7th, Seoul, Aug. 18-22 1997 (1997), 1 641-648
CA Dunbar, AP Watkins and JF Miller, “An Experimental Investigation of the Spray Issued From a p-MDI Using Laser Diagnostic Techniques”, J. Aerosol Med., 10(4), 351 (1997)
Miller, John. F., Invited Speaker, “Applications of Electrophoretic Measurements Using Phase Analysis Light Scattering”, Royal Pharmaceutical Society of Great Britain/Society of Chemical Industry, London, November 1996.
F McNeil-Watson, Fraser; Tscharnuter, Walther; Miller, John; Book of Abstracts, 212th ACS National Meeting, Orlando, Florida, August 25-29 (1996)
Miller, John. F., “The Physics of Aerosol Generation”, presented to the Management Forum (“Improving Drug Delivery From Pressurized Inhalers”), London, October 1995.
JF Miller, O Velev, SCC Wu and HJ Ploehn, “A Combined Instrument for Phase Analysis Light Scattering and Dielectric Spectroscopy”, J. Colloid Interface Sci., 174, 490 (1995)
JF Miller, “Electrophoretic Light Scattering Using Sinusoidal Electric Fields”, J. Colloid Interface Sci., 153(1), 266 (1992)
JF Miller, BJ Clifton, PR Benneyworth, B Vincent, IP MacDonald and JP Marsh, “Electrophoretic Studies of Calcium Carbonate Particles Dispersed in Various Hydrocarbon Liquids”, Colloids and Surfaces, 66(3), 197, (1992)
JF Miller, K Schätzel, B Vincent, “The Determination of Very Small Electrophoretic Mobilities in Polar and Nonpolar Colloidal Dispersions Using Phase Analysis Light Scattering”, J. Colloid Interface Sci., 143(2), 532 (1991)
JF Miller, “The Determination of Very Small Electrophoretic Mobilities in Polar and Nonpolar Colloidal Dispersions Using Phase Analysis Light Scattering”, PhD thesis (Bristol) (1990)
SP Armes and JF Miller, “Optimum Reaction Conditions for the Polymerisation of Aniline in Aqueous Solution by Ammonium Persulphate”, Synthetic Metals, 22, 385-393 (1988)
SP Armes, JF Miller and B Vincent, “The Preparation and Characterization of Dispersions of Electrically-Conducting Polymers” J. Colloid Interface Sci., 118, 410 (1987)
Patents and Patent Applications
MEASURING ELECTROPHORETIC MOBILITY
United States US 2019/0011398, Filed Oct 19, 2017
An apparatus and method to obtain electrophoretic mobility information from a dilute colloidal dispersion using electrophoretic light scattering (ELS) is disclosed. Both laser Doppler electrophoresis and phase analysis light scattering data analysis methods may be applied to a scattered light signal simultaneously. Unlike previous ELS apparatuses and methods, the disclosed apparatus and method can measure electrophoretic mobility distributions in high ionic strength media…
PHARMACEUTICAL METERED DOSE INHALER AND METHODS RELATING THERETO
United States US 8198354, Issued June 12, 2012
Methods of preparing elastomeric gasket materials for use in metered dose inhalers that include contacting an elastomeric gasket material to be used in a metered dose inhaler, which gasket material comprises one or more extractable compounds, with a solution comprising an organic solvent under conditions sufficient to extract at least a portion of at least one of the one or more extractable…
PHARMACEUTICAL METERED DOSE INHALER AND METHODS RELATING THERETO
United States WO2005023330, Filed August 25, 2004
Metering valves for use in a metered dose inhaler that include a valve body (1), a first stem seal (9) including a first elastomeric material, a second stem seal (12) including a second elastomeric material different from the first elastomeric material, and a valve stem (7) slidably engaged with at least one of the first stem seal and the second stem seal as well as sealed containers configured…
FLUORINATED COPOLYMER SURFACTANTS AND USE THEREOF IN AEROSOL COMPOSITIONS
United States US 6451287, Issued September 17, 2002
Amphiphilic fluorinated block copolymers are disclosed which are useful for increasing the dispersability of particles, preferably drug particles, in a fluorine-containing propellant.
Texas A&M University, College Station TX, 1991-2, Post-doctoral researcher
GlaxoSmithKline, Ware UK and RTP NC, 1993-2017, various positions in R&D and manufacturing
Enlighten Scientific LLC, Hillsborough NC, 2017-present, Owner
University of Bristol, UK, 1984-1987, BSc (Hons) Chemistry
University of Bristol, UK, 1987-1990, PhD Physical Chemistry