To enhance automated laboratories and further improvements in instrumental technology, bioanalytical laboratories must go through a specific transformation by overcoming their challenges.
FREMONT, CA: At present, bioanalytical laboratories are undergoing many shifting and transforming trends along with ongoing challenges. There is a pressure to significantly reduce the costs associated with bringing a new drug to the market. It cannot be accessible in a controlled, scientific setting, given the need to maintain the highest quality standards.
Another concern for the bioanalytical laboratories is the progression of deploying wet biomarkers as a measure of drug efficacy during drug development. Also, nowadays, labs are facing the challenge of how to measure deficient concentrations of specific compounds.
However, in the area of immunogenicity testing, regulators in specific instances require the use of neutralizing antibody assessments that are cell-based, which is less robust, expensive, and time-consuming compared to the plate-based counterparts. Also, as mass spectrometry technology increases, using LC/MS versus conventional ligand binding assays (LBAs) to measure select proteins has increased.
At a macro level, the labs must help contain the increasing cost of drug development. That means permitting a smarter data faster so that development decisions can be made at earlier points in time, thereby generating more significant value.
For instance, bioanalytical labs are introducing a higher degree of automated laboratory tools interfaced to flexible LIMS systems, thereby enabling the laboratory staff to accomplish more at a minimized cost. They are also ceaselessly examining emerging technologies for more efficient ways of operating.
Bioanalytical labs are evaluating many new platforms, including some that use single-molecule detection to solve the challenges related to the measurement of low-level endogenous biomarkers. Shortly, this will offer a technological runway for ultra-sensitive analysis. Besides, the qualification and use of reference material will continue to evolve through scientific meetings, published white papers, good scientific practice, and regulatory guidance related to the appropriate validation and application of biomarker assays.
Despite the drawbacks that can be associated with the use of cell-based neutralizing antibody assessments, many bioanalytical groups are gearing up their laboratories to meet the increasing regulatory requirement.
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