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Analytical approaches and regulatory expectations for characterization and control strategies for subvisible particles in biopharmaceutical products

Malvern Panalytical
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Live Webinar October 18th, 2018

Significant advances have been made in analytical technology for the characterization and identification of particles present in pharmaceutical products. With these advances comes a tremendous amount of new data with which to characterize biologics, devices, and small molecules.

In parallel with these technological advances, the regulatory agencies have shown increased interest in more in-depth characterization of therapeutic products. Careful interpretation of data and deeper understanding of the method limitations is of utmost importance when using complementary methods to characterize particle profiles of therapeutic products for regulatory submissions.

Dr. Amber Fradkin - Director, Particle Characterization Core Facility, at KBI Biopharma Inc will demonstrate how multiple particle techniques can be used to adequately characterize therapeutic products and their particle populations.

• Who should attend?

- Those working in the following areas:

- Research and Development

- Formulation and Stability

- Analytical Development

- Quality Control

- Regulatory

• What will you learn?

Attendees willl gain an understanding of which technologies are available for particle characterization in pharmaceutical products, and how to choose the right combination of technologies to characterize a product's particle profile.

You can register for free to all our webinars and you will automatically receive the On Demand version"

Analytical approaches and regulatory expectations for characterization and control strategies for subvisible particles in biopharmaceutical products

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