Promise for a cure
Research within cell and gene therapy, stem cells and tissue engineering are all relatively new technologies, but all considered groundbreaking in the quest for uncovering treatments and possibly even cures for some of the most complex diseases including oncology, heart disease, diabetes, autoimmune disorders and neurodegenerative diseases like Alzheimer's and Parkinson's. Most stem cell-based research aims either at developing personalised cell therapies, i.e. medicines based on the individual patient’s biology and medical condition, or at harvesting universal cells for broad-spectrum application.
Hospitals are on the forefront of the current development and advancements within individual treatment and are to a greater and greater extent assuming the role of researcher, manufacturer, pharmacist and treatment provider all rolled into one.
This presents huge challenges and tough requirements for not only hospital staff but also for hospital design and logistics, particularly in the context of cleanroom and containment needs.
In a pharmaceutical production facility a shutdown of cleanroom operation often means loss of a batch and loss of productivity for the company; but another batch can be produced, and the end user/patient will still get the product without any compromise on quality. However, in the hospital world, where treatments are made-to-order, there is no batch - only the therapy itself. Thus, there is one chance and one chance only to get it right. The fact that treatment of hospital patients is often acute makes round-the-clock access to cleanroom facilities vital; first of all because it ensures timely delivery of the treatment and because the product might be compromised if the processing period is too long. At worst, it can cost the patient’s life.
Such criticality calls for flexible and reliable cleanroom solutions. At the same time, conventional cleanroom design and containment needs are difficult to combine as requirements are abundant and in some ways contradictive. This all adds to the complexity of building hospital facilities equipped to process advanced personal therapies.
NNE Pharmaplan’s part
NNE Pharmaplan has experience from hundreds of cleanroom projects with many different applications within the pharma and biotech industries, and particularly in Scandinavia, we have specialised experience within design and establishment of advanced therapy facilities and hospitals.
For instance, we have helped the Norwegian Rikshospitalet University Hospital with services from design requirements, concept paper, detailed design, supervision of construction and delivery. In another project, NNE Pharmaplan delivered a turnkey cleanroom solution to Swedish-based SentoClone, a scientific research company spun out from the Karolinska Institute, which is one of the world´s leading medical universities. The customer needed a cleanroom for research and development in cell therapy and personalised drugs for cancer treatment.
Based on our overall cleanroom experience and our presence within hospital cleanroom design and consulting, NNE Pharmaplan can help customers assess their existing installations and define an optimal strategy for new ones – balancing process, quality and regulatory requirements with efficient operations and investments.