Are You Using Fit-for-Use Raw Materials to Ensure IVD Assay Performance & Minimize Risk?

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The need to comply with continually evolving regulatory requirements is placing an increasing strain on in vitro diagnostic (IVD) manufacturers. As they work to create new and effective diagnostic tools that adhere to these strict requirements, manufacturers have become more reliant on their raw material suppliers to ensure product compliance. It is paramount for them to find a supplier that not only meets the necessary regulations, but understands the way these requirements become more stringent as an IVD assay moves through the development process. Each individual company involved in the research, development, testing, and commercial manufacture of IVDs represents an important step in this process and affects the overall integrity of the supply chain.

An Expensive Process

IVD manufacturers invest a great amount of time and money in the research and development of new kits. The process – from the discovery of a promising assay to a marketable IVD kit approved by regulatory authorities around the world – may take two years or more to complete.

During the scale-up phase of an IVD kit’s development, many companies find themselves in a situation where regulatory requirements for raw materials are not very specific and guidelines are open to interpretation. Most companies will focus on reducing risk in their IVDs by pursuing supply chain transparency, change management and extensive documentation. They may be willing to use non-critical raw materials that have consistency and control, but do not necessarily meet the same GMP (Good Manufacturing Practice) standards required for their finished IVDs.

This approach changes as a company moves through the pipeline from research to commercialization, when the materials they use become subject to a grading system that defines whether they are compliant with industry regulations. This often means moving to a customized raw material rather than one that is available off the shelf.

Quality from the Start

As a product moves from lab-scale research and development through each phase along the way to commercialization, the guarantee of assay performance becomes ever more crucial. Any raw materials of lower quality used in manufacturing run the risk of containing higher levels of contaminants which could introduce unwanted assay variability. This could have detrimental effects on the IVD development process and highlights the need for manufacturers to find the right balance between cost and quality.

Raw material risk decreases as quality level increases, as supported by supplier transparency and change control.

When seeking this balance, the hardest decision for an IVD manufacturer can often be choosing the level of quality to implement in the earlier stages of research and development, before the product reaches full-scale production. Using quality raw materials from the start not only ensures that you have the right components with all the necessary regulatory back up, but it can also bring significant advantages from a cost and supply chain perspective. It also guarantees that, once the product moves forward into commercialization, it will be backed by full transparency documentation and a secure supply chain.

Each step of the IVD development process brings greater responsibility to the manufacturer. However, if the product development process is approached in the correct fashion, by the time a product hits full production scale and all regulatory approvals are completed, it should be prepared to go commercial.

What to Look for from a Supplier

Raw materials that are sourced for use in commercial products must be manufactured in a way that meets quality and regulatory requirements. IVD manufacturers should look to work with a supplier that offers fit-for-use products, from non-regulated, non-GMP raw materials to highly regulated GMP products; this breadth of offering will serve to ease transitions through each development phase.

When seeking a supplier, it is important to verify that they offer:

  • An optimized supply chain
  • Rapid resolution of supply chain and quality issues
  • A variety of risk mitigation strategies
  • Assistance in shortening timelines of your IVD development

Other important factors include:

Process Control – A qualified supplier will have top-of-the-line facilities that are equipped with the latest technologies. This allows them to consistently manufacture quality products that are reliably free of contaminants. Additionally, tight process control allows the supplier to offer clear documentation for each product, ensuring full disclosure to the customer.

Regulatory Support – With an increasingly strict regulatory environment that can vary by region, it is imperative that a supplier understands the regulations and works to stay updated on any new developments. In other words, a supplier should stay ahead of the regulations so that manufacturers are not burdened with the lengthy research that would otherwise be needed to ensure full regulatory compliance for each step of their development process.

Supply Chain Information – It is not enough to simply have a strong supply chain. A good supplier will be able to validate their supply chain with full documentation and transparency to ensure access to the materials as soon as they are needed. A supplier should provide guidelines on the appropriate quality level for each application, and provide an understanding of the implications of that decision.

Supply Chain Control – In an increasingly global market, being able to access supplies of necessary raw materials, and having an alternate source, is crucial. A secured supply chain, with redundant facilities in different locations, allows a supplier to guarantee the availability of its products, even when disaster strikes. In addition, it is imperative that a supplier has a change control notification program to keep customers constantly informed of any changes in their raw material supply.

Learn more about our M-Clarity™ program here or contact your local sales rep.