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
Resolian Acquires China-Based Bioanalytical CRO Denali Medpharma

News - Resolian, a global bioanalytical contract research organization (CRO) specializing in drug metabolism and pharmacokinetics for small and large molecules, has acquired Denali MEd pharma, a leading China-based bioanalytical CRO. Resolian now has bioanalysis laboratory operations in the U.S., U.K., Australia, and China. The company can initiate a project on four continents and easily transfer validated methods across labs, allowing therapeutic trials to extend to virtually any destination without changing bioanalytical CROs.

01 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
Resolian Opens Expanded State-of-the-Art Analytical Laboratory in Fordham

News - Resolian, a global leader providing bioanalytical, DMPK, and CMC testing services in the pharmaceutical and biopharmaceutical industry, has opened its 440m² analytical laboratory in Fordham, Cambridgeshire, UK.

30 June 2023
Alliance Pharma and Drug Development Solutions Are Now Resolian

News - Alliance Pharma, a global leader providing bioanalytical, DMPK, and CMC testing services in the pharmaceutical and biopharmaceutical industry, and Drug Development Solutions, Ltd. (acquired in 2022), today announced they will be operating under the new name Resolian — fully integrating the companies into one organization. This brings together the companies’ established bioanalytical laboratories and experts in the U.S., U.K., and most recently in Australia, as Resolian continues to expand and support the growing need for small and large molecule bioanalytical and analytical services globally.

17 May 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
Drug Development Solutions Announces Significant Expansion of Analytical Laboratory Operations in Cambridge (Fordham), UK

News - The Analytical and Materials Science (AMS) team has experienced significant growth since its inception 11 years ago and have outgrown their current lab space.  To meet this rising demand, we have started work on reimagining an empty area of our site into a new state-of-the-art AMS laboratory. This lab will be over 30% larger, providing over 440 square metres of dedicated space for analytical and materials science work. 

20 February 2023