Over the coming decade, we anticipate continuation of the trend within the industry to quickly deliver safe and effective patient-specific therapies. The biggest evolution within the industry is to develop and produce these targeted treatments at a more affordable cost to increase their accessibility.
We are already seeing these therapies influencing the way facilities are designed. Given the smaller batch sizes of the products being produced, the traditional large ballroom cleanrooms with large stainless steel vessels and piping have become a thing of the past. The cell and gene therapy applications of today are smaller in scope, less infrastructure-intense, less costly, and quicker to deploy. This has significant and beneficial implications, making it possible to expedite bringing manufacturing capacity online quicker and more affordably than ever before.
Companies are taking advantage of the standardization of manufacturing platforms (e.g., single-use bioreactors, columns) and techniques to produce drug substance and drug products, and thus it is becoming much easier to develop and provide standard facility options that meet the needs of the vast majority of the market. Rather than reinvent the wheel for every manufacturing application, there are designs available that can be quickly deployed to minimize costs and timelines. To leverage these benefits, AES has developed three standardized turnkey cleanroom options with our Faciliflex Express line of standard facility options. Faciliflex Express standard cleanroom sizes are 5,000, 15,000, and 30,000 square feet to accommodate a wide range of client needs.
We are excited to see ongoing developments with respect to contamination-control technologies that further eliminate bioburden risk within cleanrooms and the potential implication this brings to product quality and reductions in costs and downtime associated with cleaning within the cleanroom. Many of the technologies will introduce repeatability and thus a high level of quality assurance to the cGMP environments. This will enhance product quality and patient safety.
One of the things that AES is always focused on is innovating technologies and services that bring our cleanroom facilities into reality quicker and provide long-term value to our customers. Among the many near-term products or services that we will be launching to the market is our Performance Assurance Program (PAP), which is an added layer of service support for existing AES cleanrooms, additional enhancements to AES’ best-in-class proprietary cleanroom system, and a further expansion of AES’ Faciliflex product line (stay tuned!).
The COVID-19 environment has really accentuated the value of the design–build approach, along with the fully integrated services that AES offers. The pandemic has made managing multiple service providers to deliver a cGMP facility very complex and challenging, with a variety of unknown COVID-related complications. AES’ clients have found that working with a company like AES that provides their own engineering, manufacturing, and field installation services reduces known and unknown risks to projects and provides reliable project outcomes.
If anything, COVID-19 has further demonstrated that AES’ design–build approach to providing fully integrated cGMP facilities is the least risky approach. We have been proud to have been part of many Project Warp Speed applications in the United States to provide cleanrooms supporting COVID-19 vaccine production at an extremely aggressive pace. We have successfully delivered on all these projects and are excited to be part of the world’s response to this menacing global pandemic.
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