Critical reagents are an essential part of bioanalytical testing for large molecule preclinical and clinical studies. These essential components help determine the accuracy of the analyte, precision and performance of ligand binding assays (LBAs), which are key to...
For both large and small drug development companies, good communication displayed throughout the preclinical testing process is essential to success. Project leaders who exhibit great awareness, flexibility and communication skills can’t be undervalued in the timely...
There are many factors involved in designing a preclinical drug safety assessment program, but among the priorities is having a good understanding of the different requirements from the various regulatory agencies in which the Investigative New Drug (IND) will be...
PROTACs, otherwise known as PROteolysis TArgeting Chimera, emerged as a novel therapeutic modality in drug development and currently show promising clinical results for tackling some of the most complex diseases. PROTACs are designed to leverage the body’s internal...
In the design of a preclinical program, identifying and understanding the broad classification of the molecule is the priority. Is it a small molecule, a chemical, a manufactured drug? Or is it a biologic or a large molecule, a construct of amino acids, providing a...
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...
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...
New drug modalities, including oligonucleotides, bispecific antibodies, prodrugs, cell and gene therapies, and fusion proteins, offer new ways to treat human diseases once considered "untreatable." Cell and gene therapies have been around for years, but advancing...
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,...
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 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...
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...