Selecting a Contract Development and Manufacturing Organization (CDMO) can be challenging, especially given today’s evolving geopolitical landscape. These seven tips can guide you toward a successful CDMO partnership.
1) Cost-effectiveness
Conducting clinical trials in Asia often proves significantly more cost-effective when partnering with a local CDMO, largely due to lower production costs. Asian CDMOs that have undergone FDA inspections are typically viewed as more reliable – while pricier than other in this region, they still offer savings compared to their counterparts in the US and EU.
2) Quality
Having robust quality systems in place is crucial. EU and US CDMOs are often more trusted than their Asian counterparts due to regular regulatory inspections. Their established standards offer clients greater assurance, whereas some Asian CDMOs may still require closer supervision to meet similar expectations.
3) Regulatory alignment
Production materials intended for the EU or US markets must comply with the quality standards set by their respective regulatory authorities. Therefore, regulatory alignment is essential. In such cases, conducting at least part of the clinical development in the EU or US might provide strategic advantages.
4) Reliability
Drug product materials must meet high standards, and the supply chain should be reliable. Lower-cost production – such as with certain Asian CDMOs – necessitate additional oversight and control mechanisms. Conducting a quality assurance (QA) audit early in the selection process is highly recommended to ensure compliance and reliability.
5) Risk management
Implementing process controls and risk management early in the manufacturing process allows for the identification of critical parameters at an early stage, thereby streamlining the upscaling process.
6) Standardisation
Use of common techniques and appropriate equipment in the production process will support a seamless transfer to future larger-scale commercial manufacturing.
7) Timeliness of delivery
Adhering to strict timelines for on-time delivery and avoiding any material shortages during a clinical trial will ensure smooth progression of clinical trials and overall project success.
By thoughtfully evaluating these tips, the selection process of a CDMO will become more manageable and successful. Partnering with experienced experts and adhering best practices are crucial for overcoming challenges and ensuring a cost-effective and well-organized supply chain.
If you're evaluating CDMO partners, we can help you make the right choice; guided by strategy, experience, and global insight.
