The Importance of Bioanalytical Assay Services in Drug Development

Reliable yet rapid bioanalytical solutions are crucial for drug discovery and development. From early discovery and preclinical studies to clinical trials and post-marketing studies, acquiring robust drug exposure data and behavioral analysis is critical for the success of a pharmaceutical drug product. Robust bioanalytical assays are vital for processing and analyzing candidate compounds and evaluating proteins, nucleic acids, and peptides in complex biological matrices.

Pharmaceutical companies heavily focus on developing reliable bioanalytical assays. However, many companies prefer outsourcing bioanalytical method development to bioanalytical assay services. These bioanalytical service providers are experts in developing and validating bioanalytical assays. Moreover, they support bioanalytical development for every stage of drug discovery and development, from early preclinical studies through first-in-human testing and later phases of clinical trials. Such intervention guides drug developers in evaluating the fate of their drug compounds. Understanding the applications of bioanalytical services, the current article discusses the importance of bioanalytics companies in drug discovery and drug development.

The significance of bioanalytical assay services

Bioanalytical studies define the characteristics of the potential drug candidate. Hence, they are crucial for biological drug development. Besides, bioanalytical data provides vital information for regulatory filings. Therefore, more and more pharmaceutical companies rely  on bioanalytical lab partners with expertise in bioanalytical solutions and regulatory interactions.

Bioanalytical method development is new for many drug developers, especially for small pharma companies.  analytical procedures, Bioanalytical assays are more complicated than analytical procedures as they deal with undefined biological matrices consisting of millions of interfering compounds. Method development requires intense training and knowledge of drug behavior in complex biological matrices.

Also Read:  Key Considerations and Challenges in Each Phase of Drug Development

Often companies need more  knowledge and expertise required to conduct successful bioanalytical studies in-house, especially in an ever-evolving regulatory landscape. Moreover, many pharmaceutical studies are moving towards liquid chromatography-mass spectrometry analysis. These studies require expensive instrumentations and specialized training to conduct the bioanalytical assay.

Besides, most bioanalytical studies involve working under GLP compliance. Hence, labs must adhere to 21 CFR 58 guidelines. This requirement means companies should have a quality system, regular facility audits, documentation, instrument qualification, training records, and more. All these necessities make bioanalytical studies challenging for companies on a limited operational budget. Therefore, many companies prefer partnering with bioanalytical services with prior expertise in bioanalytical assays and quality systems and experience in managing FDA requirements.

Also Read: Applications of Bioanalytical Services in Personalized Medicine and Precision Healthcare

Moreover, companies may utilize and exceed the resources of their own laboratories and will need an outsourcing partner to accommodate all remaining bioanalyses. Besides, the lab may also lack experience or analytical equipment, and a contract bioanalytical assay services can provide that expertise and service.

Bioanalytical services can be a one-stop solution for all bioanalytical needs. In addition, bioanalytical services are more beneficial for smaller biotech and pharma companies. They can provide valuable consultation for services and technologies. Besides, they have a deeper understanding of most bioanalyses as they are exposed to an extensive range of bioanalytical demands. This expertise is reflected in their knowledge of global regulatory practices, as they are routinely audited by regulatory agencies, benefiting all associated parties.