The Key Challenges Faced by a Bioanalytical CRO During Drug Research & Development

The drug development process is very complex and expensive. Any delays in the timelines can have a massive financial impact. A drug development project can be derailed due to several challenges. Most of these are easy to prevent. Today biopharmaceutical companies are increasingly outsourcing bioanalysis to bioanalytical CROs. Outsourcing has helped these companies curb some of their financial burdens.

From small routine bioanalysis to more extensive drug development protocols, pharmaceutical companies outsource several aspects of their bioanalytical requirements. However, this rise in outsourcing has also increased the challenges for bioanalytical CRO. 

Outsourcing strategies, new instruments, and skill gaps are three fundamental challenges faced by bioanalytical labs. Let us study each of these challenges individually.

Outsourcing Strategies

When it comes to the bioanalysis of small molecules, they are often considered routine. And thus, a majority of bioanalytical companies outsource small molecule work to bioanalytical services. Outsourcing of novel constructs and newer drug molecules largely depends on the ability of CROs to invest in staff and equipment as analysis of complex samples will require expert technicians and sophisticated equipment. The upfront costs for running a bioanalytical CRO increase correspondingly because of this.

Large and smaller pharmaceutical companies may have distinct bioanalytical requirements. Usually, smaller companies lack the expertise and infrastructure for conducting drug development experiments, and hence they rely more on bioanalytical CROs. On the other hand, larger companies have in-house laboratories. Therefore, they may outsource more extensive studies and keep more research-oriented experiments for in-house analysis

Investments In Technologies

Investment in newer technologies is usually a financial challenge for bioanalytical services CROs. Most CROs spend more on acquiring expertise rather than novel technologies. It gets difficult for bioanalytical companies to outsource newer methods and novel workflows, importantly when these novel approaches require investment in technologies and equipment.

CROs that integrate newer workflows present themselves as potential solution partners for bioanalytical companies. Moreover, risk-sharing is a promising approach to reduce the financial burden of instrumentations on bioanalytical CROs. Risk-sharing can result in dedicated technological units at the bioanalytical CRO, while the client guarantees continuous work over an extended period.

Bioanalytical Skill Gap

Earlier scientists with a major in chemistry and some knowledge in biology were hired for bioanalytical analysis. During these times, small drug molecules were analyzed as white powders using LC-MS analysis. Times have changed now, and traditional skills are inadequate for studying complex biological compounds.

Today drug research needs an in-depth understanding of biological processes, particularly the interaction between drug molecules and biological mechanisms. CROs today need expert staff that can analyze and decipher complex biological data. However, the challenge for bioanalytical CROs is to identify these researchers and bring them together. Newer recruits lack the expertise of operating modern bioanalytical instruments, which often increases the burden of training and orientation.

CROs play an important role in the analysis of complex biological data. They are often the go-to laboratories to get more complicated work done. It is important to understand not just their functionalities but also their challenges.


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