Development and validation of an immunogenicity assay for detection of anti-AAV antibodies

Blog - Adeno-associated viruses (AAV) are small viruses that infect humans and some other primate species. The AAV is transformed from a naturally occurring virus into a delivery mechanism for gene therapy.

13 March 2023
The Australia Advantage – Why You Should Consider Conducting Clinical Trials in Australia

Blog - Accelerate timelines, lower costs, and ensure quality for your clinical research in Australia. Our advanced scientific infrastructure and world-class experts attract trials from across the globe and meet their needs with the highest standards and efficient regulatory requirements. Explore the extensive benefits of Australia’s clinical research ecosystem >

08 March 2023
Making the conscious shift to adopting risk-based Computerised Systems Validation

Blog - In the 2023 Quarter 1 issue of RQA (Research Quality Association) 2023 Q1 Quasar magazine, John Cheshire, our Senior QA Validation Officer discusses why the industry should be adopting risk-based CSV.

23 February 2023
Webinar | Challenges of developing ADA and concentration (PK or PD) assays for lysosomal transgene enzymes

Blog - One of the biggest challenges faced by the bioanalytical sector is the lack of a true reference material. As a result, in most assays, an alternative commercially available therapeutic (for example, an enzyme replacement therapy (ERT) product) can be used as a surrogate for the transgene enzyme. This webinar discusses approaches taken in order to monitor the concentration of the expressed transgene product and any associated immunogenicity.

10 February 2023
How To Build a Comprehensive Response to Client Needs as a CRO

Blog - As a CRO, meeting client expectations can be an ongoing challenge. What can organisations do to make sure their research is as effective and efficient as possible? In the Autumn 2022 issue of European Pharmaceutical Contractor magazine, the leadership team from Alliance Pharma reviews what CRO organisations can do to make sure their research is as effective and efficient as possible while meeting the ongoing challenge of their customer's expectations.

27 January 2023
AMS Sandwich Celebrates 10th Anniversary

Blog - Analytical and Materials Science (AMS) Sandwich Team recently celebrated their 10th Anniversary in an event marking Discovery Park’s 10th Anniversary. AMS Sandwich was founded in 2012 at Discovery Park – Kent’s largest science and innovation park situated just outside of the historic town of Sandwich. The team, initially comprising a few members, was formed with the aim of plugging a gap identified in the ‘Materials Science’ area of pharmaceutical development.

05 December 2022
The next chapter in Nitrosamine Testing

Blog - Based on industry feedback following the recent requirements regarding risk assessments of marketed products, a significant amount of small molecule related APIs, possibly 30%+, have been shown to have the potential to form active related nitrosamines

01 December 2022
Presentation Slides - The Importance of Good Experimental Design for Extractable and Leachable Studies

Blog - AMS Science Lead Mike Ludlow explains the importance of good experimental design for extractable and leachable studies.

10 November 2022
A step-by-step guide to developing a robust assay in bioanalysis using LC-MS/MS

Blog - Read our guide ‘A step-by-step guide to developing a robust assay in bioanalysis using LC-MS/MS’ to learn about our proven approach to developing industry-leading LC-MS/MS bioassays.

22 September 2022
What makes a good LC-MS/MS bioassay?

Blog - What makes a good LC-MS/MS bioassay? When selecting your LC-MS/MS method approach it is worth doing your homework. Pick an assay format that is best suited to your compound and consider factors such as matrix type, analyte structure, choice and availability of reagents, and the sensitivity and specificity you need.

01 September 2022