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In Houston, Texas, Avance Biosciences scientists help a wide range of customers take medicines from early testing through manufacturing. This contract research organization (CRO) specializes in bioassay design, assay validation, and sample testing for Good Laboratory Practice (GLP) and Current Good Manufacturing Practice (cGMP) submissions ) to regulators, as well as in drug testing for release as products. It is a rapidly evolving company.

“We grew 30% in 2020 and 80% in 2021,” says Xuening Huang, PhD, CEO and co-founder of Avance Biosciences. “In the first months of 2022, we’ve grown another 54%.”

Much of Avance’s growth comes from its various abilities. The company’s scientists can contribute to a wide range of projects, ranging from those involving gene editing, such as CRISPR, to various viral vector applications. Additionally, Avance works with a range of high-tech platforms, including next-generation sequencing and droplet digital PCR (ddPCR).

Advances in Gene Editing

Improvements in the methods of gene-editing technologies promise more effective treatments for genetic diseases and cancer. “We work with many partners in the pharmaceutical industry who use gene editing to modify a stem cell or T cells and put these cells back into the patient’s body as a treatment,” says Huang. “Because you’re editing the human genome, they want to know if it’s safe, and we provide innovative testing solutions to help our customers determine that.”

Avance GMP Next Generation Sequencing Services
Avance offers next-generation GMP sequencing services, such as sequencing assays for on/off-target events, which can be applied to the manufacturing and drug delivery of gene editing-based therapies.

One of the primary concerns of regulators with gene-editing based therapies is the identification of on- and off-target activity. For off-target events, biopharmaceutical companies need more than computational studies, as tests must also be performed to thoroughly analyze and resolve all off-target changes, such as deletions, insertions, inversions, mutations punctual and translocations. For CRISPR-based therapies, Avance can analyze off-target effects with various cGMP/GLP processes, including rhAmp sequence panels and next-generation sequencing (NGS) on Illumina platforms. In addition, Avance uses ddPCR technology to analyze genetic modifications, including homology-directed repair, non-homologous end joining and chromosomal translocation, created with CRISPR or other gene modification methods. The ddPCR approach detects gene editing events at frequencies as low as 0.5% or less.

To show the potential efficacy of gene-editing-based therapies, drug developers must also confirm that a CRISPR-based or other gene-editing therapy makes the intended changes, such as a knockout of gene, what Avance can do with NGS technologies.

Beyond the testing required to seek Investigational New Drug (IND) approval from regulatory authorities, Avance offers services, such as guide RNA sequencing under cGMP, that can be applied to manufacturing and to the release of drug products from therapies based on gene editing.

In all of Avance’s projects, an internal quality system guarantees precise results. For example, the company has developed independent cGMP and GLP quality units. Such a systems approach ensures compliance within Avance and the services it provides.

Improvements through early adoption

Avance is building its capabilities in analytical technology to stay ahead of the evolution of drug development. In February, for example, Avance announced that it would start using Mission Bio’s Tapestri platform.

This platform provides high throughput analysis that determines the genotype and phenotype of a cell. Thus, this technology reveals the DNA signatures of a cell as well as its protein composition. Avance will use Tapestri to analyze the transduction efficiency of lentiviruses in autologous cell therapies. The platform will also be used to study gene therapies.

“We will be the first to use this workflow and instrument in a cGMP environment,” says Huang. “So this is an example of early adoption of a technology and bringing it into a regulated environment.”

Avance will continue to validate new technologies to expand its analytical portfolio. Only then can biopharmaceutical companies push the boundaries of developing tomorrow’s therapies in the safest and most effective way.

Contact our technical staff to discuss how we can meet your assay testing needs.