Particulates in Biological Products – What to Do to Meet New Reporting Requirements?

Event Information
Product Format
Prerecorded Event
Presenter(s)
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Length
60 minutes
Product Description

Learn How to Meet FDA Expectations on Addressing Technical and Quality Aspects of Particulates in Protein Therapeutics

This webinar by our expert speaker, Dr. David Lim, Ph.D., RAC, ASQ-CQA, a global regulatory and quality compliance expert, is intended to discuss technical aspects of particulate during development of therapeutic protein products for human use.

This session will provide you with a great opportunity to become aware of and get familiar with FDA’s perspectives on particulates (visible and sub-visible) in therapeutic protein products. It will discuss what firms should consider and implement in order to detect and characterize both visible and sub-visible particulates in therapeutic protein products, including test methods and risk management.

At the end of the session, you will learn how to meet FDA expectations on addressing technical and quality aspects of particulates in protein therapeutics.

Why Should You Attend:

There is an increased scrutiny on the testing and reporting of particulates in Protein Therapeutics.

Proteinaceous Particulates in Biologics injectibles can arise from the aggregation of the protein product and can be induced by silicone droplets, metal particles and glass particles. Aggregates in protein products present a safety concern because they may increase the immunogenicity of the product. The FDA has therefore requested BLA sponsors to present sub-visible particulate data at the clinical and commercial stage. The initially identified method –gap for suitable techniques for testing particles in the 0.2 - 10 micron range is being rapidly filled by new technologies.

This 90-minute webinar addresses recent discussions in the industry related to testing sub-visible particulates in Biologics injectibles. Recent FDA expectations for reporting data will be discussed. Methods for characterization and routine testing of particulates, their advantages and limitations will be discussed. Case studies where the various methods have been used for characterization of the sub-visible particles will be discussed.

Session Highlights:

  • Applicable Laws and Regulations on Particulates
  • Definitions
  • FDA’s Current Thinking And Perspectives
  • What is Particulate Matter?
  • What to Do with Sub-Visible Particulates In Therapeutic Protein Products
  • The Present Expectations regarding the Testing For Particulates In Therapeutic Protein Products
  • Particulate Analysis in Therapeutic Protein Products
  • USP Test Methods For Particulate In Injectibles
  • Commonly Used “Work-Horse” Methods For Particulates
  • How to Characterize Particulates including Methods of Use
  • Newly Emerging Methods For Sub-visible Particulates
  • Risk Management
  • PASS-IT Suggestions

You will also get answers to the following tough questions:

  • How are the samples recruited for the trial?
  • How do the visual inspection and particulates pertain to vaccines and suspensions?
  • What is the FDA approval basis of the BLA? What will be the type of (common) clinical trials so conducted?
  • Are there any BLA-approved with QbD?
  • How can the different particle analysis technologies be applied to the samples of visible or subvisible  particle and nanoparticle products

Who should attend?

  • Healthcare industry: drugs, biologics, medical devices/IVDs, combination products, etc.
  • Compliance Officers
  • Regulatory Affairs
  • Clinical Affairs
  • Quality Assurance
  • Laboratory Personnel
  • R&D Professionals
  • Consultants
  • Contractors/Subcontractors
  • Other professionals interested in this topic

Order Below or Call 1-866-458-2965 Today

You can also order through:
Phone

1-866-458-2965

Fax

1-919-287-2643

About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert


Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.


Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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