KBI Biopharma Gains Commercial Benefit using Malvern Instruments

Introduction

The Particle Characterization Core Facility based at KBI Biopharma in Boulder, Colorado, is managed by Dr. Amber Fradkin. Headquartered in Durham, North Carolina, KBI is a biopharmaceutical contract development and manufacturing organization (CDMO) that focuses on expediting the development of biological therapeutics.

The Particle Core Facility at KBI Biopharma provides specialist particle characterization that is custom-made for the (bio)pharmaceutical sector. This specialist particle characterization service includes:

  • Profiling of particles in drug products for biocomparability and biosimilarity
  • Profiling of particles after IV-infusion
  • Identification of particles for forensics applications
  • Analysis of the kinetics of particle formation
  • Characterization of APIs
  • Evaluation of formulation stability

Analytical challenges

Amber’s team has undertaken a broad range of studies and has analyzed a variety of samples, spanning from small molecule topicals and parenteral biologics through to drug-device compatibility and inhalable powders.

Different presentation and sample matrices can pose different challenges for KBI’s technology platforms, which need application experts and advanced techniques to maximize the quality of the data collected.

KBI benefits from having dedicated experts in their field within its Particle Core team, and has more than a decade’s experience in creating and perfecting techniques for their instruments.

This has been very rewarding for us, knowing that we are supplying our clients with the most optimized methods which produce high quality data that helps them better understand their product.”

Dr Amber Fradkin, KBI Biopharma  

A better understanding and knowledge of products can help bring safer and better drugs to the market more rapidly and cost-efficiently, while meeting all the requirements of regulatory agencies, including the FDA.

With increasing awareness and understanding of the effect and significance of particles in drug products, the characterization of these particles is equally important for satisfying regulatory expectations as well as ensuring the safety, stability, and efficacy of drugs.

In order to support this critical requirement, analytical instruments have developed considerably over the last few years.

The challenge has been what to do with all of the data these new instruments produce, how to interpret it, how to store it, how to present it in regulatory filings, and so on. With the installation of routine MFI, we started to learn more about the particles in products, and what they look like.

But with this additional information came more questions: ‘Why do these particles look different to those ones? What are they?’”

Dr Amber Fradkin, KBI Biopharma.

Previously, Amber’s team used only FTIR techniques to chemically identify perceptible particle contaminants, but she agreed that using such methods would mean worrying about the issue when it was already ‘too late’.

Characterizing nanoparticles and subvisible particles early on allows for a much greater understanding of product particle profiles, which can help prevent visible particle formation related to inherent or intrinsic materials. I think of it as being proactive, rather than reactive.”

Dr Amber Fradkin, KBI Biopharma.

Solution-state analysis for particle characterization

The Particle Core scientists at KBI Biopharma required a tool that could help them finish their in-house characterization service by addressing the question: “What is it?” for particles they have identified in the visible and subvisible size range.

The team also needed a user-friendly technology with a variety of options for inspecting their various samples.

For instance, we wanted to analyze the particles in solution whenever possible, to ensure that our analysis was as close as possible to in situ particle characterization. When you are forced to filter particles out of solution, it always leaves concerns such as, ‘were the particles we found formed by the act of filtration itself?’”

Malvern was the first company to help us achieve a solution-state analysis for particle characterization by Morphologically-Directed Raman Spectroscopy (MDRS). They took our request and developed a ‘solution’ for us (no pun intended) with their wet cell for the Morphologi G3-ID.”

Dr Amber Fradkin, KBI Biopharma.

KBI demonstrated a number of systems available from other manufacturers.

We prefer to demo instruments prior to purchasing. Some instrument manufacturers require you to send samples to them for analysis, and they provide you with the data produced. But that doesn’t work so well for us - we need to have hands-on experience with instruments to know we trust the data they are producing and to evaluate if we will be able to bring a system in-house and have our analysts up to speed on the instrument operation in a timely manner.”

Dr Amber Fradkin, KBI Biopharma.

Choosing a Malvern instrument

Following stringent testing of a wide range of systems, the Particle Core team at KBI concluded that the Morphologi G3-ID from Malvern Instruments was perfect for meeting its needs.

We found that the Morphologi G3-ID system had the best ease-of-use and also the most versatility, when compared with alternative solutions. With Morphologi G3-ID, we can handle such a diverse range of samples: powders, creams, oils, aqueous solutions, solids, and so on. But also, Malvern’s customer service is outstanding. The Malvern team is very responsive to our requirements. They continuously ask for our feedback and provide rapid solutions to our requests.”

Dr Amber Fradkin, KBI Biopharma.

The Malvern portfolio at KBI Biopharma

Currently, KBI Biopharma owns the following Malvern instruments:

  • Archimedes
  • Morphologi G3-ID
  • NanoSight NS300
  • Zetasizer ZS
  • Zetasizer Helix
  • Viscosizer
  • MicroCal VP-Capillary DSC

Together, these instruments represent a complete analytical suite.

The Morphologi G3-ID has truly been invaluable to our particle characterization core facility. This instrument is the one instrument that provided the answer to ‘what is it?’ when characterizing particles. I have worked with the Morphologi G3-ID for over 4 years now - it is so versatile, and 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 identification, MDRS proves time and time again to be a powerful technique that gives us the answers we need.”

All of our Malvern instruments 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 nanometers to millimeters in diameter. Our suite of Malvern particle techniques has provided us with a unique advantage when clients are seeking help with particle characterization.”

Dr Amber Fradkin, KBI Biopharma.

Malvern as a collaborator

Amber jokingly added that some days she seems to talk more with the Malvern team than with her own team,

They are all such wonderful folks to work with and always make you feel as though you are their most important customer. They are also very technical and know their instruments and software inside and out.”

Malvern has been a very good company to work with. Over the years, I have worked with dozens of Malvern employees, from various areas of the company, including sales, service, technical specialists and product 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 their systems for our industrial applications and needs.”

“I have watched all of their instruments (Morphologi G3-ID, Archimedes, NanoSight, and so on) evolve over the past few years and I am very satisfied with the response of Malvern in the development of these technologies. I can’t wait to see how they will continue to improve their particle characterization solutions. The KBI Particle Core loves to stay on the leading edge of the industry with our technology and Malvern has helped us do that.”

Dr Amber Fradkin, KBI Biopharma.

Acknowledgements

Produced from materials originally authored by Dr. Amber Fradkin, KBI Biopharma.

About Malvern Instruments

Malvern Instruments provides the materials and biophysical characterization technology and expertise that enable scientists and engineers to understand and control the properties of dispersed systems.

These systems range from proteins and polymers in solution, particle and nanoparticle suspensions and emulsions, through to sprays and aerosols, industrial bulk powders and high concentration slurries.

Used at all stages of research, development and manufacturing, Malvern’s materials characterization instruments provide critical information that helps accelerate research and product development, enhance and maintain product quality and optimize process efficiency.


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Last updated: Apr 5, 2017 at 10:57 AM

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