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.

Sanger
Plasmid Sequencing

This ensures that the sequence of the plasmid used in the cell bank remains identical to the original sequence.

Next-Gen
Plasmid Sequencing

NGS plasmid sequencing may be used for difficult to sequence areas of a plasmid or the entire plasmid.

Next-Gen Viral Genome Sequencing

NGS sequencing may be used to confirm that viral seed stocks used for gene therapy products or vaccines remain unchanged from the original.

Viral Seed
Assays

For viral based cell banks, the FDA requires tests be performed for safety, purity, and potency be identical to the initial testing.

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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

When you partner with Avance Biosciences, you gain a CRO partner that is creative, collaborative and dedicated to sound science with a focus on the regulatory requirements our partners require. Contact our technical staff to discuss how we can support you in your project!

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Dedication to Quality

Dedication To Quality

The Avance Biosciences team is committed to strict adherence to CGMP and GLP regulations enacted by the US, European, Japanese, and other international regulatory agencies.

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Extensive Experience

Open Communication

Our team has extensive knowledge and experience working with scientists, QA/QC professionals, and project managers from over 100 pharmaceutical and biotechnology companies and organizations throughout the world.

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Open Communication

Open Communication

Transparency and integrity are two of our core values. Our well-trained, friendly, and professional study directors and project managers strive to complete your projects on-time with open communication channels and to your specifications.

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Cutting Edge Science

Open Communication

Avance Biosciences’ CGMP/GLP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, ddPCR, Sanger sequencing, next-gen sequencing, Southern blot, and more.

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