Cell line characterization is the first step in the development of a cell bank that produces a biopharmaceutical. The characterization of each cell line allows the best candidates to be screened for further development. This characterization typically includes some phenotypic and genotypic identity testing.

Genotypic
Identity Assays

cDNA sequencing data is central to genotypic identity testing. This step confirms the RNA stability of your mammalian or insect cell line.

Copy Number
Variation Analysis

Copy number determination by qPCR provides gene dosage and an indication of productivity whether the copy number is plasmid based or an integrated construct.

Structural Analysis
by Southern Blot

Southern blotting confirms that the correct structure is present in the construct of interest and helps to confirm DNA identity, size, and abundance.

Digital PCR Rare
Mutation Analysis

Droplet partitioning allows the dPCR method to effectively increase any rare target abundance; each short area of DNA is amplified including the rare mutations.

Next-Gen
Gene Integration Study

Traditionally, Southern blot analysis is the method of choice to satisfy FDA’s requirements of charactering cell line genetic stability. Avance Biosciences is now offering two NGS approaches to analyze the transgene insertion sites.

Next-Gen Adventitious
Agents Assays

Next generation sequencing is quickly gaining regulatory agencies’ acceptance as a sensitive and un-biased detection method for adventitious agents.

Next-Gen Difficult
Plasmid Sequencing

Next generation sequencing uses short read lengths and high data volumes which allows repeats and high GC regions to be more easily sequenced than with Sanger sequencing.

Next-Gen
Mutation Analysis

We have designed several amplicon sequencing assays to help the client confirm whether mutations exist in their prepared cell lines.  Two-step limited cycle PCR is followed by paired-end next-gen sequencing.

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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.

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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.

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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’ GLP/GMP 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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