AIT 2023 -- In pharmaceutical, agrochemical and industrial chemical testing, specific systems are desirable in order to effectively handle all quantities of test articles in a complete range of physical states.
AIT 2023 -- Initial technical trials delivering an oligonucleotide test material formulated into ultrapure water using a partner-designated clinical mesh micropump delivery platform identified two nebulizer performance challenges that were each capable of limiting the required nonclinical program.
CASSS AT Europe 2023 -- LC-MS peptide multi-attribute monitoring (MAM) provides primary sequence critical quality attribute (CQA) data in a single assay. MAM has been applied to re-evaluate the Pembrolizumab formulation. Pembrolizumab is an IgG4 immunotherapy that binds to the PD‑1 receptor of T-cells to induce an immune response against tumor cells.
Since the development of the first vaccines that comprised inactive or attenuated pathogens, there has been a drive to produce safer vaccine formulations comprising known and well-characterized components. One consequence of this has been the development of the subunit vaccines, which are more chemically defined and have an enhanced safety profile.
CYTO 2023 -- Chimeric antigen receptor T-cells (CAR-T) are an exciting area of therapeutics that are rapidly expanding into broader disease indications with the development of increasingly sophisticated and elegant CAR-T designs.
A recent European Chemicals Agency (ECHA) review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study or EOGRTS) aimed to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently prescribed gives sufficient information for regulatory hazard cla
ISSX-DMDG 2023 -- With the intensified regulatory and industry focus on the design and conduct of human absorption, metabolism and excretion (hAME) studies in the past 12 months, we have recently completed our 500th cohort involving radiolabelled test item administration to humans.
ISSX-DMDG 2023 -- Idiosyncratic drug-induced liver injury (DILI) is a major cause of safety-related drug withdrawal post-market for small molecule medications and a major cause of attrition during drug development. Prediction of DILI remains difficult, and the underlying mechanisms are not fully understood.
