Accelerate your Therapeutic Protein Development in a GxP Environment - Pharmaceutical Executive

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Accelerate your Therapeutic Protein Development in a GxP Environment


A 45-minute webinar on assay and system validation hosted by Marian Kelley, contributing author of DeSilva white paper*, on behalf of Gyros® AB.

During this webinar, Marian Kelley — a renowned expert on system and assay validation and GxP compliance — will guide you through:
• A brief description of the Gyrolab® platform and workflow
• A short discussion on 21 CFR part 11 in the context of GxP and system validation
• Implementation of Gyrolab in a GxP environment
• Assay validation
• Data from an assay validated on Gyrolab.

Ms Kelley will be available online following the webinar to answer questions from participants.

Who should attend?
• Existing Gyrolab user who wants to learn about system and assay validation
• Professionals working with development of protein therapeutics in a GxP environment

Register today to attend this exclusive webinar, places are limited!

Registration Fee: Free
When: Tuesday June 16th
1st session: 2:00pm BST / 15:00 CET / 09:00am EDT / 06:00am PDT
2nd session: 6:00pm BST / 19:00 CET / 01:00pm EDT / 10:00am PDT
Duration: Approximately 45 minutes, followed by a Q&A session
Where: At your desk, no need to travel
How to register: Click here to sign up

About Gyros and Gyrolab
Gyros is the world-leader in automated micro-immunoassays for therapeutic protein development. Gyrolab, the company's automated and open platform, is a versatile analytical tool that dramatically reduces the time required for optimization and execution of immunoassays. Gyrolab xP complies with the requirements of 21 CFR part 11 and comprehensive validation support is provided.

Optimize immunoassays within days
• Permits four-log dynamic range without matrix or hook effects
• Enables assay designs free from multiplexing ambiguity
• Uses only nanoliters of precious sample and reagents

If you are not available on June 16th, or if you would like to receive information on upcoming webinars simply email Maria.Schultz@gyros.com stating your preferred webinar topic and we’ll keep you informed.

* DeSilva, B., Smith, W., Weiner, R, Kelley, M., Smolec, J., Lee, B., Khan, M., Tacey, R., Hill H., and Celniker, A. Recommendations for the Bioanalytical Method Validation of Ligand-binding Assays to Support Pharmacokinetic Assessments of Macromolecules. Parm Res, 2003, Vol 20, No 11, pp1885–1900.

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