Biologics specialist Abzena has expanded its analytical capabilities at its Cambridge, UK and San Diego, US facilities.
The company will now be able to develop GMP cell-based potency assays, which are crucial when measuring the activity of a biopharmaceutical.
According to Abzena, its potency assays can be used for both GMP product release and stability testing, and will provide customers with comprehensive developability and characterisation data.
A therapeutic's mechanism of action and immunogenicity will also be determined from these assays, providing biologics companies with the data they will need to make a regulatory submission for their innovation.
The importance of potency assays is further discussed in an article by Manufacturing Chemist here.
The UK site's services are fully integrated with both the San Diego, CA and Bristol, PA sites, meaning that Abzena can serve customers efficiently across a range of areas worldwide.
Dr Campbell Bunce, CSO and Cambridge Site Head at Abzena said: “We recognise that high-quality data is necessary when making a high-stakes decision in biopharma. When it comes to early-phase biopharmaceutical programmes — especially ADCs — developers must have a reliable CRO partner with the deep knowledge and technical capabilities required, and who can deliver the necessary data needed to successfully reach their next target inflection point.”
“Our established expertise and reputation have allowed us to extend our early-phase capabilities to include GMP cell-based potency services at our global sites, addressing a critical need for our customers. By providing end-to-end support, we aim to advance our customers' next-generation programmes towards commercialisation."
Sean O’Brien, SVP & San Diego Site Head at Abzena added: “Biological drug development requires robust analytical support across all phases of development. At Abzena, we’ve placed significant importance on building a state-of-the-art analytical toolkit because we understand the value that it provides to our customers.”
“Our goal is to help our customers optimize their drug development strategies, secure funding, and navigate regulatory pathways more effectively. We will continue to invest in our expertise and expand our laboratories so that our broader analytical offering can best support them in their mission to get life-changing medicines to patients.”
