OSD
Analytical services have a vital role to play in guaranteeing the efficacy, quality, and safety of drug products through rigorous scientific testing. Sophisticated techniques and methodologies are used to validate the integrity of a pharmaceutical product and to help developers refine formulations, resolve potential issues, and optimise manufacturing processes. Ultimately, pharmaceutical analytical services ensure products going into trials and to market are effective, safe and meet compliance requirements.
These services can be applied at early and late stage development through to commercial manufacturing, they include: method validation activities, product characterisation and development, impurity identification, and global stability study support.
Specialised procedures can also be incorporated to help evaluate drug delivery performance, while sterility and endotoxin testing ensure microbiological safety for injectable products.
Another key aspect of pharmaceutical analytical services is reverse engineering. This is particularly important for generic drug development to help optimise formulations while ensuring therapeutic efficacy of the asset.
Having the right drug product analytical service support is crucial to the success of any drug development project. In his recent ‘ask the expert’ Q&A with European Pharmaceutical Manufacturer (EPM), Ramesh Jagadeesan, Vice President, Head of Analytical Services at Recipharm shares his insights on the role of analytical services at each stage of the drug development process. He also reveals his top tips for selecting a team to support this procedure.
To learn more about analytical services, you can read Ramesh’s ‘ask the experts’ Q&A in EPM here.