News & Events

News & Events2022-10-31T18:45:01+00:00
1403, 2024

qPCR or ddPCR for Bioanalysis? – Download our Comprehensive Guide

March 14th, 2024|Literature, News|

This comprehensive guide explores the essential tools of quantitative PCR (qPCR) and digital droplet PCR (ddPCR) in the biopharmaceutical industry, offering invaluable insights into their applications, strengths, and limitations. Download now to stay ahead of the curve in pharmaceutical research and development...

703, 2024

Join Avance Biosciences™ at BioProcess International West – March 2024

March 7th, 2024|Gene & Cell Therapy Testing, News|

Ensure the Success of Your Biological Drug Development - Avance Provides Assays to Support your Biopharmaceutical Development & Manufacturing - Avance Biosciences™ is a world-leading CRO specializing in GLP & GMP compliant biological assay development, assay validation, and [...]

503, 2024

Join Avance Biosciences™ at the SOT Annual Meeting – Mar 2024

March 5th, 2024|Events, Gene & Cell Therapy Testing, News|

We are thrilled to announce that Avance Biosciences™ will be attending the highly anticipated Society of Toxicology Annual Meeting in Salt Lake City, and we cordially invite you to join us! More than 5,000 toxicologists and those working in areas related to toxicology will share the latest science and technology...

602, 2024

FDA issues final guidelines on incorporating human genome editing in gene therapy products

February 6th, 2024|FDA Guidance, Gene & Cell Therapy Testing, News|

The guidance provides recommendations regarding information that should be provided in an investigational new drug (IND) application to assess the safety and quality of the investigational GE product, including information on product design, product manufacturing and testing, nonclinical safety...

1601, 2024

FDA’s Innovative Approach to Global Gene Therapy Collaboration

January 16th, 2024|Gene & Cell Therapy Testing, News|

In a landmark move, the FDA has initiated the Collaboration on Gene Therapies Global Pilot (CoGenT), signaling a significant leap toward worldwide collaboration in the field of gene therapy. This pilot aims to enable concurrent collaborative reviews of new gene therapy applications with global regulators…

901, 2024

FDA issues new draft guidelines on potency assurance for cell and gene therapy products

January 9th, 2024|FDA Guidance, Gene & Cell Therapy Testing, News|

In this draft guidance, the FDA emphasizes that potency assays and their corresponding acceptance criteria should be designed to make meaningful contributions to potency assurance by reducing risks to product potency. They provide illustrative examples of approaches to potency assay development that are...