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If research between the CRO's team continuously switches hands as scientists leave, the space for misunderstanding and error increases. And frequent CRO team churn may have a huge negative effect on productivity, with large molecule ventures frequently lasting years.
FREMONT, CA: Not all Contract Research Organization (CRO) laboratories are similarly developed. From those with wide-ranging capabilities to specialized providers, each has distinct fields of emphasis and specialization. One has to understand biologics' dynamic nature if they are searching for outsourced funding for an extensive molecule application, which makes their growth and manufacturing processes difficult.
Unlike small-molecule drugs, biologics consist of several heterogeneous molecules and are developed in living cells' culture, making them even more difficult to control; even the smallest modifications may significantly affect the potency and protection of the drug. As a result, highly trained staff and high-quality tools and equipment are required to have a strong bioanalytical base that will eventually enable successful market approvals.
It will be necessary to consider these factors when assessing CRO laboratories as possible collaborators in large molecule drug development:
What Level of Access will One have to Specialized Expertise?
An experienced bioanalytical team is of the utmost importance to ensure study progress, so who would support the day-to-day project? The reality of outsourcing is that a CRO lab will initially introduce one to its most accomplished science leaders. Still, once the project starts, such professionals do not have active in-lab monitoring. That is why evaluating the extent of bench expertise in the CRO team and posing the right questions about their commitment to project management is essential.
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Does one have the requisite depth of scientific experience from working on those experiments, and will they use these lessons to progress the novel program in innovative ways? Are they willing to send their 'A' team during the research with leadership from and ready access to senior scientists? Will the relationship be a straightforward and collaborative one?
Can They Uphold Consistency across the Project Phases?
Program consistency is an equally critical area to address to not undermine bioanalytical findings due to the fragile nature of biologic drugs. Continuity comes from two primary areas: retention of the staff and capability. If research between the CRO's team continuously switches hands as scientists leave, the space for misunderstanding and error increases. And frequent CRO team churn may have a huge negative effect on productivity, with large molecule ventures frequently lasting years.
Capacity should also be considered because it also brings quality risks of making a big molecule project changing hands among multiple CROs. Selecting a bioanalytical laboratory that can accommodate the research criteria' full scope will be a smarter option. Will they have the potential to advance the therapeutic candidate, from preclinical work to sample analysis, through development stages? Will one have decentralized access to lab locations in different geographies and countries if the research crosses continents? And should the CRO improve their team's competitiveness with technological platforms to increase the potential of analysis, simplify assay procedures, and speed up time-to-results?