One Year On...ICH Q3D Guidelines revision

Blog - It's been over a year since the ICH Q3D guidelines were updated to include cutaneous and transcutaneous limits.

10 November 2023
Beyond the Abstract: an interview with Ashley Phillips

Blog - Senior Scientist and Technical Specialist Ashley Phillips, discusses a recent publication (Single-day protein LC–MS bioanalysis: can next-generation trypsins cut it?) 

11 September 2023
8 Essential Characteristics of LC-MS/MS Method Validation

Blog - Here, we will summarize the eight essential characteristics of LC-MS/MS method validation, then explain why it is important that you work with an experienced contract research organization (CRO) to ensure quality in each of these areas: Accuracy Precision Specificity Quantification Limit Linearity Recovery Matrix Effect Stability

05 July 2023
Development and Validation of Immunogenicity Assays for ADCs

Blog - Addressing ADC Regulatory Challenges by Providing Validated Assays for Multi-Domain Proteins

31 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
Challenges of developing an ADA assay for bispecific antibody therapeutics and ADA characterisation

Blog - Bispecifics (Bs) are biopharmaceutical products that bind to two different targets (epitopes). These are mainly two types: IgG-like (antibodies Abs) and non-IgG-like which include Bites (bispecific T-cell engager) and DARTs (Dual-affinity Re-targeting Antibody).

01 January 2023
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.

01 January 2023