When we hear the phrase “personalized healthcare,” many of us think about the medicines and therapeutics focused on our specific needs that deliver treatments to dramatically improve or restore our health and extend our lives. In a Pharma Focus Asia webinar, Pursuing the Adaptive Plant to Enable Personalized Healthcare, Emerson’s Christian Berg provides a broader perspective of personalized healthcare and its challenges for the Life Sciences industry.
Christian opened his presentation by noting that Cell Therapy and Gene Therapy treatments have emerged in this past decade as viable treatments for life-threatening diseases. These treatments are referred to as Advanced Therapeutic Medicinal Products (ATMP). For manufacturers in the Life Sciences industry, ATMP manufacturing has highlighted growing challenges, including:
Two types of cell therapies are Allogeneic Cell Therapy (donor is not the patient) and Autologous Cell Therapy (donor is the patient). Gene Therapy is a modification of the expression of an individual’s genes with the administration of a specific nucleic acid (DNA or RNA). These nucleic acids require special carriers called vectors. These vectors can be viral or non-viral.
He then broadened the scope of personalized healthcare. The evolution is away from traditional healthcare, which includes these characteristics:
Personalized healthcare includes these characteristics.
Christian demonstrates how personalized healthcare works. Like traditional healthcare, it begins with the patient discovering the need for medical attention. The healthcare provider isolates the condition using traditional diagnostics such as blood samples, x-rays, CAT scans, MRIs, etc. Based on the results of the diagnostics, the patients are grouped based on expressed disease characteristics. In traditional healthcare, large-batch prescription therapies are applied to address the condition.
Where personalized healthcare separates from traditional healthcare is precision molecular diagnostics to create molecular bioinformatics used in developing individualized treatment plans. Treatment efficacy and progress are monitored with minimal residual disease (MRD) diagnostics. The individualized treatment (no longer population-based) is modified as appropriate based on these MRD diagnostics. The continuous improvement cycle of treatment, monitoring, and medication continues until the disease is no longer detected.
For biopharmaceutical manufacturers, this new approach introduces a host of challenges. Treatment is not solely a function of therapeutics; it is a function of patient-specific treatment response. Tracking must be performed from manufacturing through the individualized treatment lifecycle. Data connectivity and integrity are critical and must transcend the manufactured batch. This data connectivity for traceability and control extends to the chains of identity and custody. It is compliant with regulations such as HIPAA and GDPR for patient ID, diagnostic results, and treatments.
He identifies the challenges biopharmaceutical manufacturers face in this transition to personalized healthcare.
Christian highlighted the work of the BioPhorum Operations Group and their Digital Plant Maturity Model, highlighting increasing levels of maturity—pre-digital plant, digital silos, connected plant, predictive plant, and adaptive plant. Addressing the challenges requires advancement to the highest level with an adaptive plant. Characteristics of an adaptive plant include:
In part 2 of this post, we’ll explore the technology approaches which must adapt, the changes required in traditional system integrations, and the technologies and solutions needed to address these challenges with an adaptive plant.
Visit the Life Sciences & Medical section on Emerson.com for more on the technologies and solutions to help drive your personalized healthcare supplier strategies.
The post Manufacturing Challenges in Personalized Healthcare appeared first on the Emerson Automation Experts blog.
This is the official online community site of the Emerson Global Users Exchange, a forum for the free exchange of non-proprietary information among the global user community of all Emerson Automation Solution's products and services. Our goal is to improve the efficiency and use of automation systems and solutions employed at members’ facilities by sharing our knowledge, experiences, and application information.
User Groups |
World Areas |
Community Guidelines |
Legal Information |
Contact Community Manager
Website translation provided by
© 2015-2022 Emerson Global Users Exchange. All rights reserved.