Top Ten List of Analytical Inadequacies in IND and BLA Submissions

Today, we feature a presentation from the 2013 Well Characterized Biologicals event. Last year, Alfred Del Grosso, Team Leader, Analytical Chemistry at FDA/CBERTop presented Ten List of Analytical Inadequacies in IND and BLA Submissions.

So what are the Top Ten List of Analytical Inadequacies in IND and BLA Submissions?
1) Procedural Details
2) System Suitability Tests
3) Representative Instrumental Outputs
4) Types of Validation Characteristics / Test Categorization
5) Linearity in Matrix
6) Verification of “Compendial” Procedures
7) Robustness of Critical Assay Parameters
8) Accuracy Calculations
9) Evaluation of Range
10) Choice of Factors in Intermediate Precision

Why?  Download Del Grossso's full presentation here.

This year's perspectives from the FDA come from Lokesh Bhattacharyya, Ph.D., Lab Chief, Laboratory of Analytical Chemistry and Blood Related Products, Division of Biological Standards and Quality Control, CBER, U.S. FDA in the presentation New FDA Draft Guidance on Analytical Procedures and Analytical Method Validation for Drugs and Biologics.  For more information on this session, download the agenda.  If you'd like to join us November 3-4 in Washington, DC for the Well Characterized Biologicals event, as a reader of this blog when you register to join us and mention code XD14193BLOG, you can save 20% off the standard rate.

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Where can you hear FDA Perspectives this Fall?

At IBC’s 17th Annual Well Characterized Biologicals conference this October in Washington DC, you’ll meet and hear from multiple FDA regulators who provide you guidance to achieve success in your protein characterization and comparability efforts. We’ll help you understand all of the emerging regulatory/FDA guidances so that you can plan ahead and gain an advantage over your competitors

Hear FDA Perspective on Characterizing Biological Products

Gain an update on the US biosimilars program from Jeffrey Baker, Ph.D., Deputy Director of Biotechnology Products of CDER FDA. Obtain the latest updates on the emerging technical considerations to assure that your biosimilar products are safe and effective.

Hear regulatory considerations in the safety assessment of vaccine adjuvants and adjuvanted vaccines from Carmen Collazo-Custodio, Ph.D., Microbiologist and Primary Reviewer in the Division of Vaccines and Related Product Applications, CBER FDA. Regulatory considerations for the nonclinical and clinical safety evaluation of investigational vaccines containing novel adjuvants will be discussed.

Limit the amount of particulates in your protein therapeutics and ensure product consistency with Ewa Marszal, Ph.D., Chemist in the Hematology Division of CBER FDA's presentation on the recent advances in understanding the safety of particulate matter. Protein aggregates, testing methodologies and trends in setting standards are covered.

Be sure not to miss out on our featured FDA speaker, Alfred Del Grosso, Team Leader in Analytical Chemistry of CBER FDA's presentation on the top 10 list of analytical inadequacies in IND or BLA submissions. Hear his perspective on FDA expectation for analytical procedures and validations for drug products and drug substances.

Want to learn more? Download our agenda.

As a reader of this blog, you’ll receive 15% off the standard rate when using code XB13193BLOG to register. If you have questions about the event, contact Kate Devery (Kdevery@iirusa.com), or visit our webpage.

We look forward to seeing you October 21-23 in Washington, D.C!

Cheers,
The Well Characterized Biologicals Team

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P.S. When you register for the 17th Annual Well Characterized Biologicals conference, you’ll also have access to all sessions for the Product and Process Variants & Impurities, one of our co-located events.

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