Recently Dominic Warrino, PhD, Senior Scientific Advisor at KCAS, took part in an article with The AAPS Journal entitled “Biological Matrix Supply Chain Shortages: More Matrices Are Now Rare—the Case for Surrogate Matrices”. The piece was meant to address the ongoing series of issues being experienced throughout the industry related to supply chain issues, specifically those connected to biological matrix supply.
Dominic is on three separate AAPS focus groups – their Pharmacokinetics focus group, the Neutralizing Antibody focus group, and the organization’s Non-liquid matrices focus group. He was approached by a few of the leading voices within AAPS after a response by Warrino to a series of questions distributed by the organization about supply chain shortage experiences within the industry. The members of AAPS reaching out to Dom were intrigued by many of the techniques employed by KCAS related to supply chain issues resulting from the recent pandemic.
While many within the industry had suffered major consequences to their capacity and lead times, KCAS had seemingly avoided these issues using a combination of forecasting, pre-planning and creative problem solving around matrices options. Dominic shared with them several key things KCAS had done in anticipation of the impending supply chain shortages, like procuring various NHP matrices over a year ago after identifying a supply chain shortage in a number of areas with our in-vivo partners. Specifically, KCAS realized they were having problems getting non-human primates, so we immediately identified matrix as being part of the problem. From there, we started purchasing ahead of schedule, which resulted in allowing KCAS to provide solutions for our clients that just aren’t widely available within the industry right now.
In addition to planning ahead and purchasing early, KCAS also began a series of reviews intended to identify possible surrogate matrix options for our clients. For instance, we would typically take the hundred percent matrix – say Chinese cynomolgus plasma – and we would make our standards in QC out of that. But because of universal supply chain issues, many alternatives to the industry have been allowed (Cambodian cynomolgus plasma, for instance)..
Alternatives and surrogate matrices are nothing particularly new. There have been papers published about using surrogate matrix – as long as you are able to demonstrate equivalency – that would be acceptable. But the recent shift in supply chains resulting from the pandemic have breathed new life into the interest surrounding this field of thought and discussion.
To that end, AAPS has planned a panel for this year’s National Biotechnology Conference in Anaheim to discuss surrogate matrices and what it means for the future of the industry. As a contributor to the original editorial, as well as a member of three related AAPS focus groups, Dominic Warrino, PhD has been invited to join this panel discussion. This should be a very interesting panel and we are looking forward to posting more about it here soon.
If you plan on attending AAPS NBC next month in California, we would like to invite you to stop by and discuss any questions you have about this topic – or any others related to Bioanalytical Studies and/or Biomarkers – with Dominic and the rest of the KCAS team.