Regulatory agencies require cell bank manufacturers to ensure continued stability and safety of cell lines producing products for human use. Recommendations for cell line or cell bank testing are dependent on the species being used and the intended purpose of the product produced. Regulatory agencies determine which tests must be performed based on the species and the product, but the testing will include identity, stability, and purity.

Cell Bank Testing Services

  • 16S rRNA Sequencing

  • Bacteriophage Testing

  • Marker Retention Testing

  • Other Microbiology Tests – API 20 Test, Viability, Gram Staining, Bacterial & Fungal Impurity, E. coli Strain Identity

  • Plasmid Construct Sequencing

  • Copy Number Analysis by qPCR

  • Restriction Fragment Analysis

  • Sequencing of Expression Construct

  • Structure Analysis by Southern Blot

  • Transcript Analysis by Northern Blot

  • Copy Number Analysis by qPCR

  • Marker Retention / Plasmid Loss

  • Lytic and Lysogenic Phage Detection

Science, Compliance, Service

  • Experienced scientists functioning as project managers or study directors

  • Controlled laboratory environment to prevent cross-contamination

  • Rigorous sample tracking and handling procedures to prevent mistakes and cross-contamination

  • Methods validated per ICH GLP/GMP guidelines – also research grade testing available

  • Projects customized and tailored to suit your needs

  • Independent quality unit assuring regulatory compliance

  • Transparent process flow and weekly report on project progress

  • Professional project reports ready for regulatory filing

  • Fast turn-around time & Competitive pricing

Services

GLP/GMP Compliant
Biological Assay Services

Have questions?

We are dedicated to timely, high-quality service from the start of your project to the finish. Send us a note or give us a call to find out what Avance can do for you.

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Ready to get started?

Give us a little background on your needs and the goals of your project, and we’ll send a preliminary quote including: tasks, deliverables and a no-obligation cost estimate.

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Our Customers Say…

Avance Biosciences™ (AB) has delivered the Sequencing data in a record time. Very impressive! We have benefited from AB’s hard work and are very grateful for that. AB team should feel proud of themselves. We thank AB team for their support and contributions, much appreciated.

Head of Quality Control, Microbial Manufacturing Service, California

Your team met the timelines we needed and did exceptional technical work. I will definitely make my management aware that Avance is a very capable partner for our bioanalytical needs.

Bioanalytical Senior Project Manager,  California

My experience with Avance has been nothing but positive… I will keep sending work your way as I appreciate the attention your team provides and Avance’s creative technical team. See you soon.

Director Individualized Medicines,  California

Avance has been the ideal partner in helping Mission Bio and our client,… be the first in the world to GMP qualify our single cell % transduction assay for a lentiviral gene therapy product. Excellent execution on the part of the Avance team. We look forward to more collaborations in the future.

Senior Director, Cell & Gene Therapy Business,  California

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!

Partner

Dedication to Quality

Dedication To Quality

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

Extensive Experience

Extensive Experience

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.

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.

Cutting Edge Science

Open Communication

Avance Biosciences™’ GLP/GMP compliant genomic and microbial assays make use of the advanced technologies including real-time PCR, digital PCR, Sanger sequencing, next generation sequencing, and more.