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Today, pharma bioanalysis is outsourced and has broadened in scope, as large molecule drugs have become a significant part of many organizations' drug development pipelines.

FREMONT, CA: The biologics market is growing, resulting in increased demands on pharmaceutical and biotech firms to produce biologics more quickly. In the past, companies chose to manage drug development and production internally with scientists' in-house team. However, with heightened competition, restricted timeframes, and potential challenges, it has become vital for most pharmaceutical and biotech firms, regardless of their size, to consider using CROs as a remedy for more efficient development and production. Deciding to outsource can positively influence a study's outcome, especially when working with the right CRO.

Across pharma, there has been a small portion of bioanalytical work that was outsourced to a CRO. Back then, the usual outsourcing strategy was to outsource some late-stage clinical studies to CROs, while assistance for preclinical and early-stage clinical studies was retained within pharma. Over the years, streamlining of pipelines and mergers and acquisitions, the bioanalytical resources at both pharma and CROs have adjusted accordingly with a vast downsizing of internal bioanalytical resources at pharma and a rise in resources at the CROs.

Due to these alterations in pharma, there is a requirement to strategically move more bioanalytical work to CROs. With this change of work from pharma to CROs, talented bioanalytical scientists at pharma are also migrating to CROs, creating a great and sustainable partnership between pharma and CROs. Presently, bioanalytical practitioners at CROs are considered to be equal to their peers in the industry. Method development and other challenging bioanalytical work traditionally conducted in-house at pharma can now be reliably supported by CROs.

To accommodate the requirements of offering bioanalytical support for the present pharmaceutical drug discovery and development environment, both pharma and CROs are collaborating their resources strategically in a synergistic manner. It is never too early to think strategically about how and when to move the internal potentials to the external providers so that pharma resources can be better prepared for managing the next challenge on the horizon. Equally, CROs also want to find a new business model beyond just offering cost-saving for pharma, such as investing resources in new technologies and increasing innovative collaborations with pharma on resolving new bioanalytical hurdles.