Two of the scientific experts from KCAS Bio have been leaders in determining the direction of qPCR and ddPCR technology for the industry. Carrie Vyhlidal, PhD and Jonathan Mercier are both part of the American Association of Pharmaceutical Scientists’ working group for PCR-based methodology, and they have recently been lending their expertise to discuss challenges and considerations in performing qPCR and ddPCR studies. Both of these technologies are growing rapidly – particularly as gene and cell therapies are on the rise in our space. However, there remains a lack of regulatory guidance for these assays.

There are regulatory guidance documents for different biomedical bioanalytical method validations, but they are specific to like and binding assays and chromatographic assays. These differ pretty significantly from molecular workflows, so the AAPS group sat down together over the last year or so to discuss considerations to promote a harmonized and sound approach to method development for these molecular assays, as well as the establishment of best practices for method validation considerations of critical reagents for all PCR assays supporting any cell and gene therapies.

How KCAS Bio’s expertise can help lead the way in PCR best practices

It is important in that these work groups represent the industry by involving those with the experience to give valuable insight and leadership in deciding what comes next for these relatively new technologies.

The molecular team at KCAS Bio brings many years of experience in performing these assays, especially when considering how long the technology has been used. KCAS Bio has become a voice of authority on topics related to cell and gene therapy and the molecular space especially. Collectively there are well over a hundred years experience performing these assays, so it is truly a good thing for the industry that KCAS Bio is participating in these conversations and contributing to these conversations.

What comes next for PCR for molecular cell & gene therapy?

While there are currently no specific regulatory guidance, there are a number of white papers. The European Bioanalysis Forum has put out a white paper, as well as the Japan Bioanalysis Forum, each evolving and making slightly different recommendations. What the AAPS working group is trying to do is take these existing pieces, along with previous considerations and our own recommendations to try and harmonize all of them into a more cohesive set of recommendations for these assays growing in use and popularity.

There will no doubt be regulatory guidance for this part of the industry. However, in the meantime it is very important as that we, as an industry should make our voices heard and offer our reasonable recommendations on best practices for these assays.

By participating in groups like this, KCAS Bio is participating and ensuring that our positions are understood. Until there are official guidance for PCR technology, KCAS Bio is making sure that we are involved with those leading the conversation about best practice. We do this to help lead the industry in toward what we feel is the best direction for the future, but we also do it so that our customers can be rest assured, knowing that by the time guidance are eventually released for these technologies, KCAS Bio will already be at the forefront of those following them.

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