Drug Research & Development Overview

Drug Research & Development Overview: Understanding In-vivo And In-vitro Approach In Bioequivalence Testing. CRO Diaries: Defining The Role Of Bioanalytical Labs For Biotech Research And Development

Bioanalysis studies biological samples to analyze molecules such as DNA, proteins, and other large and small biomolecules. The terms analytical and bioanalytical services are loosely used in the drug development industry. However, bioanalytical services are associated explicitly with toxicology studies, bioavailability studies, bioequivalence studies, and several other pharmacology studies in animal and human study participants. These services are available for each phase of the drug development process, from discovery to post-marketing stages.

Today there is a growing demand for partner laboratories among the pharmaceutical and biotechnology industry. Escalating costs and extended study duration are two primary reasons for the rising demand for contract bioanalytical laboratories. These reasons have made drug development companies outsource bioanalytical studies to respective laboratories specializing in those domains. Moreover, the escalating need for drugs for chronic diseases has further increased the burden on drug development companies. Contract bioanalytical labs can help meet most of the drug development needs. Let us understand the role of bioanalytical labs in the drug discovery and development phase.

Why are bioanalytical labs crucial for biotech research and development?

Developing a bioanalytical method is entirely new to many. It requires intense expertise and in-depth knowledge of analyte behavior in complex biological matrices. Moreover, bioanalytical method development services are crucial, and unlike analytical studies, bioanalytical studies deal with complex biological samples containing millions of interfering compounds that may affect the specificity and accuracy of analyte evaluation.

Furthermore, biotech companies may find it challenging to acquire the necessary expertise quickly, especially with the ever-evolving regulatory landscape. Not to mention, most bioanalytical studies today are moving towards LC-MS analysis. LC-MS instruments are expensive and require dedicated expert professionals. Most bioanalytical testing services have a dedicated team to conduct these experiments. Therefore, they become ideal for most drug development companies, particularly companies with a lean budget.

As most bioanalytical testing needs GLP considerations, companies must adhere to 21 CFR 58. It means bioanalytical companies should have a quality system in place, regularly audit the facility, maintain records, qualify and optimize instruments, and many more. Hence, as discussed earlier, maintaining these regulations becomes impossible for most small-size bioanalytical companies. Small-size companies find it effortless to collaborate with method and assay development services that have already demonstrated the expertise of data presentation to the regulatory bodies.

Most often, drug development and biotech companies max out their testing capacity and may need to outsource the work to a contract research organization. Also, companies sometimes lack the expertise or bioanalytical equipment to conduct a specific experiment. Again, here they can outsource those evaluations to a partner bioanalytical laboratory. Drug Research & Development Overview: Understanding In-vivo And In-vitro Approach In Bioequivalence Testing.

The road ahead
There are numerous reasons for a bioanalytical company to partner with contract laboratories. Contract laboratories can become a one-stop-shop for all their bioanalytical needs, particularly for companies with limited resources. Furthermore,  an established laboratory may develop and acquire expertise in a diverse range of bioanalytical solutions over the years. This expertise, coupled with a deep understanding of regulatory requirements, makes contract bioanalytical laboratories the best option for biotech and drug development companies.

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