To ensure drug product quality and safety, the FDA requires GMP-level Lot Release analysis for each biopharmaceutical batch produced before it can be released for sale, or export. This analysis requires identity, purity, and potency to be completed for all new lots of biologics and it requires comparison with previously established results. Comparability testing ensures that each new batch of product remains identical to the original batch.
Our Customers Say…
From the preliminary conclusion of this work, we are already pleased to thank you for your customer-oriented approach and proactive communication in the course of this study. We are happy to see the profound difference in business mindset between your organization and our previous vendor…
Project Manager, Belgium
Thank you so much for successfully completing this important project for us on time. We are very satisfied with the final report and thank you for taking the extra effort to customize the report format. We will definitely use your lab for future projects.
Program Manager, California
It has been a pleasure working with you and your team. The project was carried out to the highest standard and delivered in a timely manner. I will definitely recommend Avance Biosciences’ services to colleagues and friends.
Senior Scientist, Singapore