At Malvern, we love hearing stories from our customers about how they use our technologies to help them better understand and control their products. From time to time we are going to share some of these stories in a feature we have entitled “Customer Spotlight”.

Amber FradkinOur very first Customer Spotlight is from Amber Fradkin of the Particle Characterization Core Facility at KBI Biopharma in Boulder, CO. Amber received her Ph.D. in Chemical Engineering within the Pharmaceutical Biotechnology Program, with a specialization in the field of immunogenicity of therapeutic protein aggregates, at the University of Colorado at Boulder. Amber also holds a Masters degree in Science from the University of Colorado at Boulder, plus a Bachelor of Science degree from the Colorado School of Mines.

What are you working on, and what do you find most challenging and also most rewarding?

I manage the Particle Characterization Core Facility at KBI’s Boulder site.  We specialize in particle characterization tailored for the pharmaceutical industry.  Working in a CDMO environment is exciting because we get to use our instruments for a variety of products and wide-range of applications (parenteral biologics, small molecule, topicals, powders, device compatibility studies, etc.).  However, the broad range of sample types (and particle types) that we characterize can be challenging, because each instrument requires specialized techniques for optimal data collection, depending on the sample matrix and presentation.  All of the members of the KBI particle team have extensive experience (10+ years) developing methods for each of our particle instruments and we offer method development with hands-on technical training for our clients.  This has been very rewarding for us, knowing that we are supplying our clients with the best optimized methods that produce high quality data for them to use to better understand their product.

To what extent do you use your Malvern instrumentation?

We have seven Malvern instruments and each one of these instruments gets used at least once a week. Our most popular instrument, the Morphologi G3-ID, is running almost constantly.

How have these instruments impacted your business?

Our Malvern technologies have been integral to the KBI Particle Core.  Each instrument provides a unique dataset to characterize particles.  Applying the right combination of techniques allows us to characterize the full particle profile, spanning from nm to mm.  We have found great interest in the pharmaceutical industry for a ‘one-stop particle shop’.  Many contract testing companies offer one or two particle techniques, but our industry-leading suite of Malvern particle techniques has provided a clear advantage when clients are seeking help with particle characterization.

Which is your favorite system, and why?

Hands-down the Morphologi G3-ID – this is the coolest instrument on the market today!  This is the one instrument that provided the answer to, “what is it?” when characterizing particles.  I have worked with the system for over 4 years now, and find it so versatile.  It works brilliantly with powders, filters, solutions, gels, ointments, and so on.  Whether we are using it to develop a method for determining particle size distributions of multi-API topical drug products, or isolating subvisible particles from biologics for forensic ID, the Morphologi G3-ID proves time and time again to be a powerful technique.  We never get tired of characterizing particles with Morphologically-Directed Raman Spectroscopy!

What led you to choose Malvern as your supplier for instrumentation?

Morphologi G3Malvern has been a very good company to work with.  I have worked with dozens of Malvern employees, ranging from areas of sales, service, technical specialists and development.  Malvern has always been interested in the continuous improvement of their systems.  Our team works closely with Malvern to provide feedback on how to improve systems for our industrial applications and needs.  I have watched all of their systems (Morphologi G3-ID, Archimedes, NTA, etc.) evolve over the past few years and I am very satisfied with the response of Malvern in the improvement of these systems.  I can’t wait to see how they will continue to improve the particle technology.  The KBI Particle Core loves to stay on the leading edge of the industry with our technology and Malvern has continuously helped us do that with our systems.

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