Bioanalysis services constitute a critical element in the drug development process. The number of new compounds finding a passage from discovery to the biopharma industry for product development has increased radically with the progress in discovery science.
A spectrum of assays has been discovered over the past few decades to test the suitability of a new chemical entity as a drug candidate. Multiple analytical procedures are also available for both generic products and prescription drugs.
Pharmaceutical companies often outsource this vital task of bioanalysis. That makes it crucial to know how to assess the quality of a bioanalytical laboratory.
The Bioanalysis Process
This article uses the term bioanalysis to imply the application of the biological matrix throughout the drug development process for the quantitative measurement of an active drug. The bioanalytical process changes focus at different stages of drug development.
The focus in the early stages is on identifying and refining methods of analysis best suited to precisely and competently measure the drug level across diverse biological matrices. At later stages of drug development, logistical capabilities get added to scientific capacity.
Sample transport and trials at multiple sites involve considerable expertise in data management. The quality parameters for bioanalysis efficiency involves more than just technical capacity, therefore.
To choose an agency for bioanalysis services, it is important to check several quantitative and qualitative factors. Some of these criteria are globally valid while some others are specific to the US. We present a well-researched list of yardsticks to facilitate identifying the best bioanalytical labs in the USA.
Method development, validation, and transfer often need different resources. It is necessary to check the capacity of a bioanalytical lab in each of these areas. Competency in method development implies the optimization of lab resources to meet the specific objectives at each drug development phase.
Method validation is a regulatory need to prove the scientific soundness of the measurement. For instance, the Food and Drug Administration (FDA), USA, needs toxicology studies to adhere to specific provisions of Good Laboratory Practices (GLPs).
Method transfer, i.e. the formal process of evaluating the suitability of a method at another laboratory becomes necessary if the analytical method changes at any stage of drug development. All three activities often get less attention as these are routine.
However, they play a critical role in the temporal duration and cost-effectiveness of the drug development process. That makes it important to check a lab’s capacity in each of these areas.
The experience of a laboratory in offering the specific bioanalysis services required needs to be checked in four areas:
- Experience in dealing with the particular class of compounds and/or the techniques necessary
- Experience in dealing with regulatory compliance needs, such as the number of methods validated annually
- Experience with the use of information technology for data management
- Experience in effective communication with reference to the availability of contact persons and reports
The performance and productivity measures that a bioanalytical lab uses are important in this connection. Check a company’s track record and seek the opinion of existing customers.
It is imperative that the laboratory has inbuilt quality control systems. GLP compliance is a regulatory need for FDA approval. However, a lab that prioritizes quality audit beyond compliance needs certainly has an edge over those that do not.