To help assure patient access to sterile injectable (SI) medications and meet the current needs of developers, aseptic facilities must be fit for a future of flexibility. What’s the secret to creating cost-efficient aseptic capacity and a facility that is truly flexible? Grant Merrill from AES Clean Technology discusses
Over the past two decades or more, cleanroom engineering and construction has matured to meet the evolving, growing demand for more flexible cost-efficient manufacturing space. Cleanroom environments and the sterile processing capacity within them are mandatory to produce vaccines and emerging biologic drugs in high demand by healthcare providers (HCPs) and patients – and a systems approach to the cleanroom is taking centre stage.
An extremely wide range of advanced therapeutics are administered as parenteral drug products. The stars of the pharma universe currently are the 11.8 billion doses of messenger RNA (mRNA) inoculations that have been delivered globally. Now a blockbuster-enabling technology, mRNA-based pharmaceuticals are poised to take off near-term and set to provide a solid foundation for the huge growth expected for injectable drug products of all kinds.
The market for all sterile injectable (SI) drugs and their delivery devices is growing fast. Many of today’s most advanced therapeutic molecules are parenteral, administered via injection or infusion and dispensed by healthcare providers (HCPs) around the world.
The pathway to operational readiness needs to be as short as possible because time is of the essence
According to Fortune Business Insights data, the global injectable drug delivery market is projected to reach $1.2 trillion by 2027. In particular, the administration of biopharmaceuticals by global HCPs to treat chronic conditions like arthritis, diabetes and other autoimmune diseases continues to drive global growth and development of injectable drugs. For just this category of pharmaceuticals alone, the market is projected to reach $856 billion by 2030.
One thing that all injectable drugs have in common is that they must be sterile and that they require tremendous technical acumen to manufacture successfully. Industry surveys confirm that much of pharma in this sector, whether they have the internal capacity or not, also outsource a significant portion of processing and fill/finish operations to external contract partners. Markets and Markets for example, predicts the global fill-finish manufacturing market to grow from $12.1 billion by 2025, at a double-digit compound annual growth rate.
The major factors driving this growth, note Market and Market analysts, include rising technological advancements in fill-finish manufacturing processes, growth in the biopharmaceutical sector and increasing adoption of prefilled primary packaging and combination devices.
There will be a continued and expanding need for cost-efficient commercial-scale sterile drug manufacturing capacity, necessary to deliver injectable medications safely and affordably to patients.
With parenteral drugs every dose requires an aseptic process train within a highly controlled manufacturing space to assure 100% product sterility. For much of pharma’s manufacturing history, sterile environments were dedicated to a product and built large enough to achieve the economies of scale necessary to deliver a return on the capital invested.
Traditionally, cleanrooms were fabricated on-site over long complex project timelines using stick-built construction methods. For much of pharmaceutical plant history, the fact that this method was cumbersome to engineer and slow and expensive to construct, was not an issue providing it functioned, was validatable and compliant. The traditional development of commercial pharma cleanroom space historically involved a “committee” of contractors and technology integrators to deliver the cleanroom space. Such a list might include a host of team members to cover all critical project elements, but without a single source who was ultimately responsible for the performance of the cleanroom asset:
Over the past two decades or more, the concept of modularity in cleanroom engineering and construction has matured. One thing the industry has learned over the years is that the complexities of these stick-built integrations required coordination among many members of the project team, none of whom were wholly responsible for ultimate project performance.
So, instead of a committee of disparate contractors and equipment suppliers integrating a cleanroom system on-site without the use of any modular technology, the industry now can leverage a single supplier to deliver a complete, turn-key system to the site with a guarantee for complete project performance, including strict environmental controls within the cleanroom as well as predictable results for cost and schedule.
The modular cleanroom systems available today are engineered to accommodate virtually any commercially viable floor plan both horizontally and vertically
Most plant operators know one key benefit of having single-source system supplier comes well after construction and commissioning when the aftermarket support truly shines from the expert that developed and delivered the functional cleanroom asset. A common historical complaint was that once the execution team was gone, there was no single entity to support ongoing maintenance or troubleshoot operational challenges” with the cleanroom system.
Modular technologies delivered as a comprehensive system offer a cascade of cost-efficiencies in construction and subsequently in operation. This is especially true relative to the expected demand for modular cleanroom systems to support the SI manufacturing sector.
These and similar drivers have led to significant innovation, primarily in the form of engineered, modular cleanroom systems. Developed with standard factory-fabricated modular components, cleanroom systems are purposely designed to simplify implementation of the aseptic manufacturing space that the industry needs to meet future SI capacity demand.
Emerging drug development strategies and therapeutic delivery models continue to prompt the industry technologists to improve the economics associated with the commercial implementation of complex cleanroom spaces. One tactic increasingly being employed is to characterise the cleanroom space as a complete and critical system, on par with the multiple high-speed fill/finish lines that the site’s processing suites might contain. Pharma’s facility engineers understand the best way to implement cleanrooms faster and more cost-effectively is to leverage advanced modular design, engineering and prefabricated components and deliver it as a completely integrated, cohesive system – a functional entity.
In the current era, the design, manufacturing and delivery of the integrated systems that are the foundation of commercial operation can vary greatly.
A single-source system supplier responsible for the delivery and quality of the entire integrated cleanroom system can provide multiple benefits:
Modularity helps streamline installation schedules and lends an element of precision that traditional methods can’t accommodate. The industry’s modular cleanroom integrators understand critical coordination, from process systems to infrastructure tie-ins, is required to ensure there are no gaps in responsibility that can disrupt project timelines or operations later.
The modular cleanroom systems available today are engineered to accommodate virtually any commercially viable floor plan both horizontally and vertically. This approach is more flexible and offers higher quality at a lower price with quicker validation timelines than traditional stick-built facilities.
Modular configurable cleanroom systems can mitigate the many “unpredictabilities” of project execution. Experience has shown that modular technology can help shave months off construction timetables because it streamlines installation and minimises coordination.
Commissioning is the systematic and documented approach to verifying that a cleanroom performs as intended, in accordance with the product’s process and manufacturing needs. Whether a build-out strategy calls for piloting a primary facility then expanding it or siting the same sort of sterile aseptic facility multiple times, the advantages become clear.
The integrated design, fabrication and commissioning that is inherent to modular cleanrooms sets the stage for consistently repeatable results. The pathway to operational readiness needs to be as short as possible because time is of the essence. These days, something any SI drug strategy can ill-afford to waste while on the fast track to treating patients.
All evidence suggests the innovation is winning in the market. According to fact.MR analysts, the global modular cleanroom solutions market is set to experience rapid growth at a compound annual growth rate of more than 10% from 2020 to 2030. Over the past several years, notes fact.MR, the market expanded at a healthy rate because of elevated demand from the pharmaceuticals sector.
Further, they report advancements in cleanroom construction and the adoption of modular integrated HVAC systems are also responsible for expanding the demand for modular cleanroom systems. Over the next 10 years, explains fact.MR, demand for configurable and customisable modular cleanrooms leveraging current Good Manufacturing Practices will become more widespread across pharma.
Modular cleanroom solutions support key development and commercialisation goals, timelines and regulatory agency approval milestones. Over the past 20 years, modular cleanroom facilities have become a key enabler in the safe and effective manufacture of drugs, and with each breakthrough, proving how simply effective the solution is in helping pharma build out capacity in a financially sustainable way.
As a pioneer of turnkey cleanroom solutions, our team at AES Clean Technology understands that modular approaches to cleanroom deployment can deliver significant capital expense control, as well as the ongoing operational benefits that the biopharma industry needs to meet its most aggressive market objectives faster.