We are seeing a trend in the life sciences industry moving away from blockbusters to niche busters, population based medicines and even to the extreme of personalized medicines. The Emerson Life Sciences consulting team recently had the opportunity to work with one of these emerging companies that is using a novel process that genetically engineers each patient’s own T cells to recognize and kill cancer cells.
For this type of company, the process actually begins when a patient’s blood or is drawn or a biopsy is taken. This involves providing a unique patient identifier for tracking the lot from collecting the specimen, shipping to the manufacturing site, processing to make the final product, and shipping back to the location for the patient treatment.
As you can imagine when dealing with patient specific blood or biopsy components, it is imperative to ensure that the right product gets back to the right patient. In this regard, one of the significant challenges that a company like this faces is ensuring that the right material is tracked properly through the entire process.
As such, they need to confirm the “chain of custody” of the batch through the cell expansion and activation process ensuring that the right batch is processed properly according to the batch record. This means that the right samples are taken and the right results make it back to the right batch, the right parameters are collected, the process is well documented, and finally that the right batch makes it back to the right patient.
From a software perspective, the basis for the electronic batch record to confirm this chain of custody includes the Syncade Smart Operations Management Suite‘s Materials Management module (MM) with Electronic Work Flow (EWF) and Document Manager.
Emerson Process Management has worked with pharmaceutical and biotech manufacturers to solve these types of challenges. Typically, this begins with a discovery study to define the functionality needed, develop the scope, evaluate requirements, and determine any standard solution and customized functionality needed to meet these challenges. Connect with our team to discuss some of the challenges your organization faces.
From Jim: You can also connect and interact with other pharmaceutical, biotech and manufacturing execution system experts in the Life Sciences and Operations Management groups in the Emerson Exchange 365 community.