Our Integrated Development Services division is playing a vital role in helping to turn drug candidates into first-in-man formulations. Our team has the scientific knowledge, skills, equipment and techniques to deliver a wide range of development activities to clients working in agrochemicals, biopharmaceuticals and industrial chemistry.
Working closely with our Integrated Discovery Services division, we turn drug candidates into nominated drugs for pre-clinical development, providing support at every stage. The move from discovery to development begins with an evaluation of lead candidates. In this pre-nomination stage this type of assessment has become increasingly important.
Advances in synthetic techniques mean candidates are often produced with good biological profiles but poor drug-like properties. By assessing physical and chemical characteristics such as stability, solubility and permeability, in conjunction with absorption modelling and early formulation development, we get to understand how potentially ‘druggable’ a biological target is.
To rapidly evaluate the druggable potential of lead candidates we first comprehensively determine the physical-chemical compound characteristics using an advanced and diverse array of analytical techniques as well as in silico packages.
A range of screens are then employed (depending on the determined physical-chemical properties) and include crystallisation/co-crystallisation, salt form, polymorph, GRAS excipient solubility and drug-excipient compatibility platforms.
Where required we offer a range of API processing techniques including spray drying, micronisation or lyophilisation. Suitable pre-formulations are then prepared and scaled for early stage toxicology safety studies or discovery toxicology screens for final candidate selection prior to formal GLP studies.
Our investigative toxicology teams are acknowledged experts in the design, performance and interpretation of pre-clinical investigative and mechanistic toxicology programmes. These programmes are typically intended to identify the toxicological mode of action/adverse outcome pathway (AOP) affected by the compound in question. Mechanistic data generated is frequently used in submissions to regulators.
As our development work continues through scale up and CMC activities we can manufacture batches of pre-clinical API and impurities for pre-nomination studies and then improve the process chemistry route and its scalability of nominated APIs.
If you would like more information, or would like to discuss your specific requirements with one of our team, please call any of our sites direct or complete