Bioanalytical studies are an important aspect of biologic drug development that may necessitate partnering with bioanalysis experts.
Beyond the regulatory requirements for conducting bioanalytical studies, the scientific importance of the data that these assays generate is invaluable. Bioanalytical assays provide information on certain safety aspects of a therapeutic in determining the maximum tolerated dose. Pharmacokinetic scientists use the data to determine exposure, half-life, and other pharmacological parameters and possible safety issues, which are used to guide decisions on how often and how much of a therapeutic should be given for efficacy without undue toxicity.
Partnering with contract laboratories can be extremely beneficial, and there are a number of reasons for doing so. The capacity in your own lab may have been exceeded and the need to outsource work to a partner lab would be necessary. Your own lab may be lacking in certain analytical equipment or experience, and a contract lab would be able to provide that service and expertise. CROs are particularly useful to smaller biotechs as the CROs can provide valuable consulting services and an expanded scope of service offerings such that they can be a ‘one-stop-shop’ for all of your bioanalytical needs. CROs have a very deep understanding of bioanalysis based on the number and diversity of assays they have developed. This is reflected in their scientific expertise as well as their understanding of global regulatory practices, since they are more frequently audited by multiple regulatory agencies, and these factors end up benefiting all of their clients.
With over 1,500 assays developed in support of over 2,500 studies and with management experience averaging 21 years, ICON Development Solutions has the bioanalytical expertise and track record required to deliver rapid, dependable results. To speak with one of our experts, please contact us.
This blog is an edited version of “The Importance of Partnering for Bioanalytical Studies” which appeared in BioPharm International on 1st June 2020. To view the full article, please visit https://www.biopharminternational.com/view/importance-partnering-bioanalytical-studies