Bioanalytical studies are the foundational components of drug development as these studies provide necessary data to define the safety and efficacy of a drug product. Data from bioanalytical studies are also crucial in filling regulatory compliances. Hence, many drug developers are finding it necessary to outsource studies to bioanalytical labs that have in-depth experience in drug development and can help new parties with an introduction to drug discovery and development. Understanding the importance of an outsourcing partner, let us dive deep into the benefits of connecting with bioanalytical laboratory services.
Advantages of outsourcing studies to bioanalytical lab services
Many drug developers are new to the method development of bioanalytical studies. Method development needs intense expertise in the subject matter and in-depth knowledge of how target analytes behave in biological samples. Besides, unlike analytical studies, bioanalytical studies comprise complex matrices with millions of interferents affecting the accuracy and specificity of bioanalytical methods.
With an ever-evolving regulatory space, it is challenging to navigate the way and acquire in-house expertise. Moreover, the advent of LC-MS systems has made acquiring method-related expertise expensive. It has forced companies to set up these systems and train lab staff in these specialized instruments.
Moreover, most bioanalytical studies require work carried out under GLP conditions. Hence, bioanalytical labs must adhere to 21 CFR 58. This adherence means drug developers should have a quality system, conduct regular audits, maintain documentation and records, instrument qualification, and other requirements. All these regulatory specifications become too heavy for companies with a limited budget. Therefore, it is much simpler to connect with a bioanalytical laboratory service that has demonstrable expertise in bioanalysis and data presentation to regulatory agencies.
Besides, better utilization of resources is another crucial benefit of outsourcing partners. By having a bioanalytical lab with specialized services as an extended partner, drug developers can focus on more complex issues around the pharmacological approach to drug discovery and development. Depending on the sponsor organization, a bioanalytical lab can flexibly perform bioanalysis., A partner laboratory can be the only option for bioanalytical studies for a small company. On the other hand, midsize and big companies outsource larger studies while retaining smaller or more complex projects.
De-risking investments is also a crucial aspect of outsourcing bioanalytical studies. With such a complex and risky endeavor, drugs often fail during the development process. Partnering with a bioanalytical lab can help sponsors de-risk investments as they can leverage specialized equipment of the laboratory and ultimately reduce the upfront costs associated with buying these specialized technologies. Setting up and running a bioanalytical laboratory involves buying real estate and expensive laboratory instruments. Besides, employing and retaining highly skilled staff further increases the costs associated with running bioanalytical laboratories. Hence, connecting with an experienced bioanalytical laboratory reduces the costs and provides on-demand expertise in the ever-evolving pharmaceutical space.
Today many small and large pharmaceutical companies outsource preclinical and clinical studies to bioanalytical laboratories. However, outsourcing bioanalytical studies depends on several factors, including financial, business, technical, and logistics. Hence, the advantages and disadvantages of partnering with bioanalytical laboratories can be subjective.