Shared Alexion Resources
Approaches to Rare Disease Studies
Platforms such as high-throughput screening (HTS), cell-based assays, and research models can be designed to mimic specific diseases using CRISPR and stem cell technology, providing more disease-relevant data for safety studies and eventual translation to the clinic.
Enter the New Era of CNS
CNS drug discovery isn't for the faint of heart. We can't be deterred by clinical failures, but it's clear that some approaches aren't working. It's time to building upon the foundations of our current research and start over. Get ready to explore new tools and techniques to generate data that drives confident decisions in the earliest stages of development.
SOT Safety Pharmacology Poster Presentation
This study demonstrated both the comprehensive electrical evaluation of the heart and repeatability of the electrophysiology testing protocol for arrhythmia generation, and for safety evaluation of new chemical and biological entities.
Are You Ready for the Digital Pathology Revolution?
The digitization of pathology data for diagnostic and decision support, peer review, and computer-based analytics, or digital pathology, is here. Potentially more objective, accurate, and faster than traditional microscopy, the technology is changing our workflow. Our pathology experts have presented a three-part webinar series so you can discover platforms, learn best practices, and put a plan in place to harness the power of digital analysis in your preclinical programs.
Considerations for Clinical Sample Analysis
With well-established experience in sample management and kit assembly for Phase I through III clinical trials worldwide, we produce over 1,300 sample kits per month. In many cases, our scientists are involved at the start of nonclinical programs and stay on through subsequent testing, collaborating as part of the clinical study team. This approach results in robust and reliable methods for clinical sample analysis, which, when combined with data management, enables us to provide high-quality, on-time clinical data to support drug approval.
In addition to clinical bioanalysis, we also offer extensive biomarker testing services, including clinical efficacy/PD biomarkers, which are crucial for confirming target engagement and improving your chances of moving to Phase III. Through our CLIA certification, we can also develop novel biomarkers for use in diagnostic testing, post-market patient safety monitoring, and companion diagnostic testing.
Pharmacodynamic (PD) Biomarkers Video
Russell Garland, our Group Leader of Analytical Services, discusses the advantages of using clinical efficacy/PD biomarkers.
Who Should You Trust to Run Your Product Release Testing?
With over 20 years’ experience supporting method development, phase-appropriate validation, and release testing, let us handle your routine testing so you can focus on more pressing matters. We provide a comprehensive package of GMP product release services, from addressing biosafety concerns and analyzing potency using suitable bioassays, to determining purity and other biochemical characteristics. Our assays follow US Pharmacopeia (USP), European Pharmacopoeia (EP), and Japanese (JP) guidelines.
Preserve the Safety of Your Biologics
Viral clearance studies are essential to ensure product safety. With laboratories in Europe and the US, we have the technical and regulatory expertise to ensure studies comply with relevant guidelines (e.g., EU, US, Japan, and WHO, including ICH QSA). Regulatory authorities have accepted all of the viral clearance studies we’ve ever submitted to them for review. We can support a range of products, including tissue- and blood-derived products, vaccines, and medical devices.
Learn more about viral clearance studies by attending our upcoming 5th Annual Viral Safety and Viral Clearance Summit in October. Join thought leaders and experts as they share the latest trends, techniques, and regulatory requirements in the industry.