All drug supply chains are complex. Whether the drug is a generic painkiller made with APIs sourced in India or China or a monoclonal antibody produced in cell lines in Europe using media from the U.S., keeping track of materials is always difficult.
For personalized medicines there is another level of complexity, says Kathie Schneider, director, global commercial lead, Terumo Blood and Cell Technologies. She urges personalized therapy firms to keep distribution in mind when adopting innovative technologies on the factory floor.
“Most companies are investing in digitalization of their manufacturing processes, including the systems used in manufacturing,” notes Schneider. “For cell and gene therapies, digitation is also important to connect the chain of custody and identity, therefore digitization is not only increasing in the manufacturing process, but also as the product travels from clinic to manufacturing and back to the patient.”
An effective chain of custody relies on the exchange of information between systems which, Schnieder points out, means developers need to ensure the software used during all stages of harvesting, receipt, production, and distribution can communicate.
“For cell and gene therapy manufacturing, multiple tools and technologies are utilized. These technologies can span from manual to automated unit operations to integrated process operations. They work may work with different software, or do not have software connection points to lab notebooks or LIMS,” she continues. “Without having an open communication system, it is hard to transfer data from one system to another or to an electronic management system for communication among multiple platforms and can present risk of data entry errors.”
Schneider also warns personalized medicines firms not to underestimate the amount of information each patient-specific therapy is likely to generate.
“Capturing data in a system that facilitates compliance that can be easily accessed by the users and admins is also a challenge, particularly given the complex regulatory policies covering data security and privacy,” she explains. “For a single patient, there is a large amount of data that is collected and stored – into 100s of pages that are collected throughout the process.”
Whether the personalized medicines sector ever achieves its full potential depends on multiple factors. For example, in addition to proving efficacy and safety, manufacturers are yet to find cost effective ways of making patient specific medicines[i]. Others suggest securing reimbursement is likely to be the biggest hurdle for the industry.
But in terms of the logistical challenges the signs are encouraging according to Schneider, who says more firms are investing in digital technologies that connect production to distribution.
“The continued evolution of bespoke tools in the cell and gene therapy space to encourage moving away from manual system to automated unit operations may presents additional opportunities of digitalization,” she tells GEN.
“As the industry demands systems capable of integrating with centralize data collection and aggregation platforms, integration of unit operations can be more achievable which is evidenced by progress seen in bioprocessing.”
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