Avance Biosciences is a leading provider of biologics safety testing for both eucaryotic and procarytic cell lines, offering Sanger sequencing, qPCR, Southern blot, northern blot and other molecular biology and microbiology methods to support biological drug development and manufacturing.
Biological discovery and development testing for NBE (New Biological Entity, an antibody, protein, gene therapy, or other biological medicine) requires confirmation and characterization of the product prior to preclinical testing in humans. The goal is to screen putative molecules for safety, kinetics, and potency to eliminate all but the best candidates for clinical trials.
Cell line characterization is a critical 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.
Regulatory agencies require cell banks used for biologics manufacturing to be extensively tested for their identity, stability, and safety. Various FDA guidances and ICH guidelines define the required tests for different types of cell banks.
The vial seed bank must be extensively characterized to insure the resulting viral passages (including the Working Virus Bank) remain the same genotype and phenotype as the initial master viral stock. Additional tests that are required for viral stocks include: identity, safety, purity, potency, fungal and bacterial sterility, mycoplasmas, and adventitious viral testing.
Avance Biosciences offers our clients worldwide custom solutions to support their preclinical safety studies and clinical trials. Our team is specialized in supporting DNA biodistribution and RNA expression of gene and cell therapy animal toxicity studies with real-time PCR assay development, validation, and tissue testing under GLP. We are also offering real-time PCR, digital PCR, next-gen amplicon sequencing to support clinical trial pharmacokinetics studies.
To ensure drug product quality and safety, the FDA requires GMP-level Lot Release Testing for each biopharmaceutical batch produced before it can be released for sale, or export. This testing requires identity, purity, and potency to be completed for all new lots of biologics and it requires comparison with previously established results.
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.
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, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner. Contact our technical staff to discuss how we can support you in your project!
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.
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.
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.
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.