Having the full spectrum of information about the early investigative work completed, as well as safety assessment goals and expectations for the successful development of a new drug, is essential in order to create the most effective preclinical strategies. Dr. Mark...
Preclinical Testing
PART 1 – Understanding New Modalities: Oligonucleotides and Bispecific Antibodies
As our understanding of genomics and biological pathways expands, human diseases, once thought untreatable through conventional therapies, are well within our realm of intervention. Oligonucleotides ("oligos") and bispecific antibodies (BsAbs) are two new modalities...
Grand Opening of New R&D Center in China
The Nanjing Branch of the DMPK Business Unit Begins Operation Grand Opening On May 24, 2021, the Nanjing Branch of the DMPK business unit of WuXi AppTec’s Laboratory Testing Division opened for business in a grand fashion. The event attracted many presenters,...
ICH M10: Preview New Bioanalytical Method Validation Guidance
The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) is in the process of revising M10, a multidisciplinary guideline that governs bioanalytical method validation. Drugs need to contain the correct...
Pathologists Can Move Your Drug Development Program Forward
Pathologists examine the causes and mechanisms of diseases and, in the world of drug development, that means collecting, processing and analyzing tissue for toxicity. Histotechnologists fix tissue samples onto slides, stain them to distinguish types of cells and cell...
WuXi AppTec Grows Biomarker Capabilities with Quanterix
The newest partnership between Quanterix and WuXi AppTec Laboratory Testing Division (LTD) integrates industry-leading instruments and reagents with world-class laboratory and technical staff to form the co-developed Simoa Joint Lab in Shanghai. Starting in 2021, drug...
How DMPK Lead Optimization Mitigates Risk and Conserves Resources
Lead optimization in the world of drug development is a multifaceted process. It is a crucial part of discovery pharmacology and toxicology, as such, is used to identify and advance the most promising drug compounds. First and foremost, lead optimization aims to...
WuXi AppTec & Quanterix Simoa Joint Lab Opening Ceremony
On April 23, 2021, Quanterix and WuXi AppTec's Laboratory Testing Division (LTD) inaugurated the "Joint Laboratory for Biomarker Clinical Analysis" at WuXi AppTec's headquarters in Shanghai. The event attracted more than 50 guests including Dr. Steve Yang, WuXi AppTec...
You’ve Got Molecules, We’ve Got Solutions
We offer a true, single-platform, end-to-end solution that can be catered to your specific drug discovery and development needs – saving you money while providing industry-leading turnaround times. With solutions for both small- and large-molecule development, our...
Partner Up – A Nonclinical Talk with Toxicology Consultant, Grace Furman
Engaging the right partners at the right time is essential to drug developers and the success of their compound. We sat down with Grace Furman, small-molecule toxicology consultant at Paracelsus, Inc., to get her perspective on some of the most pressing challenges and...
Addressing Safety Testing of Drug Metabolites (MIST) in Drug Development
Metabolites in safety testing (MIST) has become an integrated part of drug metabolism research in drug development, and is a widely discussed topic within the drug development industry. Recent guidance from the U.S. Food and Drug Administration (FDA) on safety...
Internal Standard Variation Case Studies: A Look into the Latest Whitepaper
The use of Internal Standards (IS) is essential to Liquid Chromatography-tandem Mass Spectrometric (LC-MS/MS) quantitative bioanalytical methods. Yet, there are no set methodologies or widely adopted criteria among laboratories for establishing and assessing Internal...