As an assay developer, you understand the importance of having quality controls and standards for your assay, but what does it really take to manufacture them?  It may not be as easy as it appears and there are a number of questions beyond choosing the type of controls. Will the assay be improved if the controls are lyophilized? How can false positives/negatives be reduced? Which controls will you want manufactured, and which can you safely and reliably leave to your customers to provide?

Above all, how can you ensure that the controls are high-quality, reproducible, and free of contaminants?

Above all, how can you ensure that the controls are high-quality, reproducible, and free of contaminants?

Here are some challenges with developing proper controls and standards for your diagnostic assay:

 

Challenge 1: Contamination and false positives

When designing assays in research and product development, avoiding contamination is critical. In manufacturing, it becomes even more crucial as the ramifications are higher. As an example, it is possible that an internal control can become contaminated if the manufacturing facility is running PCR tests for quality checks, causing a slow, creeping contamination of the entire space. In this real-life scenario, even a miniscule amount of nucleic acid can cause problems. Situations like these can lead to manufacturing of assays that give false positives when they are in the hands of the end user—leading to potentially disastrous results.

When designing assays in research and product development, avoiding contamination is critical.

The Argonaut solution:

To eliminate the chances of cross-contamination of controls, Argonaut Manufacturing Services has built an entirely separate and dedicated custom controls and standards facility. This facility boasts all of the standards and capabilities of its sister facility: full GMP, automation, lyophilization, and ISO 13485:2016 and 9001. The brand-new Palomar Oaks facility also houses all custom controls manufacturing, including lyophilization and filling. Most contract manufacturing organizations do not offer custom controls services, let alone manufacturing in a dedicated facility and the ability to lyophilize all components.

 

Challenge 2: Selecting the right type of control/standard

With so many different types of controls, which one is right for your assay?

Perhaps the most important distinction among all of the different types of controls is the difference between the procedural and internal control.

Perhaps the most important distinction among all of the different types of controls is the difference between the procedural and internal control.

Procedural control—Alerts user if the test process does not run correctly by indicating an invalid result. This type of control will need to be present at every step of the assay, from sample to result.

Internal positive control—Material that closely approximates the target to demonstrate validity of results.

Internal negative control—Utilizes a sample containing no target (like water or sample matrix) to ensure no contamination or unwanted amplification.

Dive deeper into the different types of molecular diagnostic assay controls here.

The Argonaut solution:

Our team of experts can assist you in determining which type of custom control or standard makes the most sense for your specific assay. Need it lyophilized? No problem. In fact, lyophilized controls can have longer stability, provide simpler end-user protocols, and ease logistics by removing cold-chain requirements. Lyophilized components may also reduce risk of possible contamination.

 

Challenge 3: Production

If you’ve addressed the possible contamination problems and know exactly which controls to employ, there is always the issue of producing the entire assay (including controls) in a reproducible and scalable manner. Here, it is important to consider things like final formulation, mixing, dispensing, labeling, kitting, and packaging. Without proper consideration, assay production can turn into both a costly and time-consuming burden on your organization.

Without proper consideration, assay production can turn into both a costly and time-consuming burden on your organization.

The Argonaut solution:

Argonaut provides seamless end-to-end production for your assay, controls and standards, from formulation, lyophilization and fill all the way to fulfillment.

Need assistance with custom controls or standards for your molecular assay? Let’s discuss the right manufacturing for your needs.  Contact Us – Get in Control Today.