The US has gone through immense change over the last few years, like most countries on the planet. A pandemic, the chip shortage, and a concurrent push for domestic manufacturing have caused spikes in industries across the country.
The cleanroom services industry has seen the country through these changes and is now a hugely different scene. The physical structures are the obvious change, as demand has soared with the need for mRNA vaccines. But once these facilities are in place, the services and skills required to run them are the next step in the evolution of the sector growth.
Reaching the next level
A Tech Services team representative from STERIS said: "As more cell and gene therapy facilities and vaccine production sites are built in the United States, the competition for human resources and talent has increased dramatically. Teams at many of these sites are already stretched thin, and turnover rates have increased."
This rapidly growing pipeline of new therapies in cell and gene therapy means the STERIS Technical Service teams have been engaged in numerous programmes to support the training needs and contamination control strategies for these facilities as well.
The representative went on to say that this means there has been strong demand for products that are easy to use, and that reduce the potential for errors. "These products include ready-to-use chemistries, handy pre-saturated wipes and custom-designed sterilisation wrapping systems that make sterilisation and aseptic presentation easy," they say. "In addition, we see a strong demand for support in development of contamination control programmes, disinfectant qualification, and in development and delivery of operator training programmes"
Decontamination companies are working with engineering firms on projects that integrate VHP as a building utility
CEO and co-founder of PathogenDx, Milan Patel, also spoke on the microbiology service sector. He explains that it is not just the capacity that is being pushed to the extreme, but also the capabilities. "We are reaching a point where companies (and the industry as a whole) are being asked to not only test for the pathogen in the product, but also narrow down to a sub-type," Patel says. "I expect demand in the sector to increase, as both technologies capable and spaces suitable to test at this level will be necessary."
As an example of this trend, Patel talks about a project that PathogenDx is looking forward to this year as the detection of Salmonella serotypes in poultry. "This is needed and long overdue because Salmonella outbreaks and illnesses have not decreased, so the USDA FSIS is now drilling down to the next layer, looking at the pathogens causing sickness or death in contaminated poultry outbreaks," he explains.
The STERIS representative is also seeing this trend for more in-depth results. "Our labs are busy characterising microbial populations found in cleanroom environments and the disinfectant susceptibility of new strains and variants," they say. "Our R&D teams continue to innovate to address emerging cleaning and microbial control challenges identified while working with our customers."
Another take on the need for increased capabilities is in the enrichment stage for microbiological processes. "Innovation in rapid enrichment technologies is key," Patel says. "A core challenge has been improving the turn-around time of microbiology for larger volume matrices -- results still take 24-48 hours. Additionally, product can often be on hold for long periods, waiting on micro results before it can be shipped. In the last few years, there have been tremendous strides in accelerating the enrichment process."
Keeping it clean
With the popularisation of vaporised hydrogen peroxide as a decontamination tool across a wide array of industries, the demand skyrocketed. "Many customers view VHP as a failsafe technology to reduce the risk and high cost of a contaminated product batch," the STERIS representative says.
Investment in this sector is not like to decrease any time soon, as new facilities for vaccine manufacturing continue to crop up. STERIS is hopping on this trend, the team representative explains that the company is working with architectural and engineering firms on projects that integrate its VHP as a building utility, to decontaminate production spaces more efficiently throughout the facility.
For the infection control sector, keeping up with the latest trends in the engineering sector is key to understanding the future trends in their own. A new class of entrants into the sector means experience is lacking and that is a void that needs to be filled. "Many smaller biotech start-ups that don"t have the funds or the ability to wait for several months for a stick-built cleanroom will be looking at modular cleanrooms, which can meet the ISO Class 5 environment requirements and can be expanded, modified or relocated as necessary," the STERIS representative explains.
The infection control expert goes on to say that these new entrants will need to quickly understand and meet regulatory requirements for their cleanrooms and processes and this will require them to rely on specialised outside resources for direction and assistance.
The domino effect
One of the biggest trends on the engineering side of the industry has been the increased infrastructure for biotechs in the US, with vaccines and CGT innovations at the beating heart of this. "Most of these drugs will require cleanroom manufacturing," the STERIS team says. "Likewise, the growth of medical devices as drug delivery systems, and the centralisation of compounding pharmacies, are driving the need for more cleanrooms."
The representative says that geographically, this is shown in growth across the country, especially regarding cell and gene therapy facilities which generally have a smaller footprint than the blockbuster biotech drugs have traditionally required.
There has been strong demand for products that are easy to use that reduce potential for errors
This trend in more, but smaller, facilities is something that many infection control specialists should keep in mind as they build their client list. These trends will most likely continue to increase over the next ten years as the population ages.
Another trend that is greatly influencing where the demand for cleanrooms comes from is the stiff competition for qualified workers the industry is currently facing. As a result, STERIS sees customers "focusing on what they do best", the actual manufacturing of the drugs themselves. "They then outsource non-drug production activities," the STERIS team adds. "Cleanroom cleaning services, gowning services, contract laboratory testing, and cleanroom certification services (ex. HEPA and HVAC) are all growing year-over-year."
The team thinks that most pharmaceutical manufacturers are now wanting to provide some of the puzzle pieces, but have partners who can manage their complete end-to-end needs, and who can provide highly trained and motivated workers, with minimal turnover.
There is no way to talk about the effects of a pandemic on a country without touching on containment and sterile manufacturing. The introduction of mRNA vaccine technology and the speed with which the COVID-19 vaccines were approved and manufactured stand out as amazing innovations. Right now, there are several mRNA-based vaccines in the pipeline and one thing that all of them have in common is the need for sterile processing.
"For many years, sterile production has trended toward the removal of operators as a potential source for contamination," the STERIS representative gives as an insight. "This has led to the greater adoption of isolators and RABS systems."
While the increased demand for containment systems to reduce the strain on trained operators is directly impacting that industry, this is not where the aftershocks stop. "Helping customers clean and decontaminate RABS is a challenge we work on daily," the STERIS team says passionately.
This is where expertise is key, as some of the considerations include substrate compatibility, efficacy and access to the areas within these systems. Though the technology in containment has advanced greatly in recent years, it is not likely to ever be a truly "simple" process.
The domino effect of the pandemic is far more than just a booming cleanroom construction industry that is straining to keep up with demand. It is a need for monitoring expertise, consumables capacity, infection control innovation, containment knowledge, and dedication to microbiological advancement.
At the heart of this, it is a technical skills shortage in a time of a worker shortage, that needs to be addressed to keep the wheel turning.