Activities

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.

PRODUCT DEVELOPMENT

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.

EXPERIMENTAL DESIGN

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.

ZETA POTENTIAL

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.

INSTRUMENT DESIGN

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.