The next chapter in Nitrosamine Testing

Blog - Based on industry feedback following the recent requirements regarding risk assessments of marketed products, a significant amount of small molecule related APIs, possibly 30%+, have been shown to have the potential to form active related nitrosamines

01 December 2022
Presentation Slides - The Importance of Good Experimental Design for Extractable and Leachable Studies

Blog - AMS Science Lead Mike Ludlow explains the importance of good experimental design for extractable and leachable studies.

10 November 2022
Challenges of developing an ADA assay for bispecific antibody therapeutics and ADA characterisation

Blog - Bispecifics (Bs) are biopharmaceutical products that bind to two different targets (epitopes). These are mainly two types: IgG-like (antibodies Abs) and non-IgG-like which include Bites (bispecific T-cell engager) and DARTs (Dual-affinity Re-targeting Antibody).

24 May 2022
Introduction to Pharmacokinetics

Blog - An understanding of the characteristics of drug exposure following administration and how it relates to safety and efficacy is critical for progressing drug development (e.g. in decision making for drug candidates, design of dosing regimens and making predictions for future studies) as well as being a requirement for regulatory authorities. Pharmacokinetics (PK) analysis aims to evaluate quantitatively how a drug enters the body, what happens to the drug while in the body and ultimately, how it is removed. These processes are commonly referred to by the acronym ‘ADME’, which comprises absorption, distribution, metabolism and excretion.

07 January 2022