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 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...
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...
Encountering challenges while developing a new drug is expected, but drug developers who understand the pitfalls are often better prepared to navigate them and emerge successfully. Nonclinical safety assessment is a highly complex and molecule-specific process, but...
Explore our New Jersey facilities from wherever you are working, even the comfort of your own home. Virtually tour our New Jersey facilities in Cranbury and Plainsboro to learn about our Bioanalytical and DMPK capabilities and instrumentation to support your drug...
Developing biologic solutions is a complex process, and bridging bioanalytical assays from preclinical to phase I clinical trials is a demanding step in advancing your therapeutic. While maneuvering through regulatory requirements and intensive testing, it is easy for...