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guide

13 Keys to a Successful Monoclonal Antibody

BLA Submission

Is your cold chain ready?

In this guide, the experts from Modality Solutions discuss 13 keys you need to know to ensure your cold chain is ready and your filing successful.

Achieve a successful mAb BLA submission with this proven checklist from Modality Solutions.

Read our guide to learn:

  • Factors you should consider for Primary Packaging Qualification
  • The right approach to Risk Assessments
  • What to include in your Validation Master Plan
  • What aspects are vital to address in your Logistics Network Design
  • The unique advantages of Drug Product Simulation Testing
  • ...and more

Download the Guide

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MEET OUR EXPERTS

About Modality Solutions

Modality Solutions is a privately owned biopharmaceutical cold chain engineering firm that supports expedited regulatory approval for biologics.

Modality Solutions has experience unlike any other team in areas such as stability testing, packaging qualification, and validation master planning. Our team of multi-disciplinary engineers can create a strategy to help your biologic gain faster approval with fewer delays.