Risk Mitigation in IVD Manufacturing

Why should you prioritize risk mitigation?

Assessment of critical raw material performance, supply and quality is important to minimize risk. Risk must be assessed and mitigated throughout the entire IVD commercialization process.

Your critical raw materials require active risk mitigation to ensure:

• Manufacturing continuity
  
• Lot-to-lot consistency
  
• Regulatory compliance
  
• Clinical test reliability

The pillars of risk mitigation are:

• Supply chain
  
• Quality
  
• Risk assessment
  
• Contract manufacturing

Below are examples of risks coming from raw material supply and in-house manufacturing capabilities that have been identified by IVD manufacturers and where we have programs in place to support you.

Best Practices for Mitigating Risk in Your Supply Chain

Risk mitigation strategies include selecting fit-for-use products and a variety of commercial arrangements depending on whether your IVD assay is at the R&D, pilot, or manufacturing stage.

We keep your needs at the center of our supply chain through:

• Continuous communication and collaboration
• Understanding the IVD market’s needs and expectations
• Making our supply chain work for you

We understand the importance of your materials being delivered on time in full and at the required quality level.

Supply Chain Risk Assessment Program

This comprehensive tool is a powerful means to achieve greater insight into the supply chain of your critical raw materials, the associated potential risks, and recommended proactive risk mitigation solutions. This provides value for all steps of IVD development, from R&D through commercialization.

Bulk, Custom and Contract Manufacturing

Our quality systems and regulatory expertise combined with a full range of custom and contract manufacturing services provide global solutions for IVD manufacturers.

These capabilities help reduce your risk and accelerate your commercialization by providing a viable alternative to costly capital expenditure and facility expansion. Let us partner with you from the development of the initial concept, through scale up and final manufacturing; ensuring that you have quality products, at the optimal scale and format, at the right time, to aid your rapid commercialization.

• Streamline your IVD production by leveraging our global manufacturing expertise
• Unrivalled flexibility with customized filling and packaging