Standardized Cleanrooms Give Biopharma the Speed it Needs
Sid Backstrom, Vice President of Business Management
PODs - The Early Days
When we began building our cleanroom PODs a little over ten years ago, more than one industry stalwart expressed confusion and/or concern as to how our prefabricated approach would even work. I came up with several quick retorts like “When you buy a bioreactor, do you design it yourself and have it assembled at your site?” Some would get it. Some took more convincing. We decided to convince further by consistently getting better.
When we grew to adolescence and had built our own in-house teams for project management, project engineering, quality, safety, commissioning and automation, we started to see adoption by the industry, first by small companies who were willing to try something different, then by larger companies who, after having built a number of purpose-built mausoleums, knew that another approach had to be tried. Being young and aggressive, there was not a lot we said “No” to. We learned to make bigger PODs, connect PODs and stack PODs. We went from eight-foot-tall (8’) ceilings to sixteen (16’) feet tall, from eighteen (18’) foot wide to now sixty (60’) wide and beyond. We learned to integrate corridors, MALs and PALs, wall panels, safety showers, pass throughs, and many others.
And over time we steadily in-sourced almost everything. Automation including EMS offerings, Test and Air Balance, IQ/OQ, etc., we developed the expertise we knew our clients expected.
The Need for… You Guessed It, Speed
Through the years, one request has been constant. “How fast can you get it to me?” If we could deliver PODs in a year, the client wanted them nine months. If we could deliver in six months, the client wanted them in four. As you might expect, COVID-19 didn’t change that. Not surprisingly, requests for expedited deliveries became more aggressive.
In response to that, we could have taken the position that our ability to deliver is already market leading at six to eight months so why should we make changes. But harkening back to our roots, we are driven to improve and meet the challenges our clients present to us. We have often said that our clients’ challenges are our challenges and their success is our success.
The timelines they have requested are not requested without justification but are made to be able to provide therapeutics for urgent medical needs, COVID-19 chief among them.
How Can We Roll PODs Out Faster?
As we started to think about how we could produce faster, one industry consistently came to our collective minds, the automobile industry. Automobiles for the most part are not custom made like cleanrooms are. Automobiles are offered as standards, often with a few levels for each standard. Subaru is a good example. For example, the WRX comes in five models, the WRX, WRX Premium, WRX Limited, WRX STI and WRX STI Limited. The vehicle body type is the same in each. Each has all-wheel drive. The seat construction, dashboard, air conditioning system are the same for each level. The packages offer differences in engine size, wheels, seat surfaces, stereo, sunroof, etc. But what is clear is that these standard offerings are well-defined and are readily available at a known cost. The vehicle you desire is often on the showroom floor and if it isn’t, it can be ordered and delivered in weeks. Also, if you walk into a dealership for Subaru or any other major automaker and ask them to sit down with you and start designing your car, you are going to at least get some funny looks.
Why are cars bought in this way? Because designing, building and shipping them one at a time would be cost prohibitive and extraordinarily time consuming. With the myriad of features and capabilities modern day cars have, designing a car from a blank sheet of paper to a finished vehicle would take months if not years. After those decisions are made, procuring every part individually and at a reasonable price would also be a monumental task. Assembling all parts, without an assembly line approach with dedicated equipment and personnel, would likewise be extraordinarily inefficient. And ultimately and most importantly, the functionality of such a one-off production is unknown.
In similar fashion, if we sat down with every cleanroom customer with a blank sheet of paper and said, “What did you have in mind?” that process would be long and inefficient. Designing the space, engineering the requirements, choosing the materials of construction would all be limitless exercises that could last months and even years. Procuring those disparate selections with no purchasing power would likewise be laborious. And just like in the custom car scenario, building without the benefit of specialized personnel and without the use of SOPs and proper kitting and equipment would generate an artisan crafted product with an artisan craft price. In the era we live in, such an approach has no value.
Challenges Bring Opportunities -Standardization
With the auto industry in mind, we looked at our prior sales and asked what are our “best sellers?” What features and equipment do we include the most in our PODs? What floorplans, material and personnel flows do we most often see? What areas do we see where the need for options exist?
After that holistic review, the answers were clear. We saw that our standard POD portfolio of six (6) PODs will fulfill multiple applications within the industry. These standard PODs have dimensions of 12’X 50’ X 13.5’, 17’ X 50’ X 13.5’ and 24’ X 50’ X 13.5’ with bi- and unidirectional personnel and material flows. In a world of process intensification and patient-based batch profiles, cleanroom infrastructures do not need to large and complex, but fast and scalable. We liken these PODs as our Premium models because we think our PODs are premium in the market. If you stick with the standard features, these PODs can currently be delivered to you in three months because the engineering is done, the parts are already in our shop at the time of order, the standard operating procedures for manufacture, quality control and commissioning are already in place, the shipping RFQs are already written, etc. In the future, when the standard POD portfolio gains acceptance, we will mass produce these units and abbreviate the delivery time even further.
If there is a need for an ISO5 space, maybe we call that a WRX STI, G-CON can still provide the same and we think we can do that as well or better than anyone else in the cleanroom space. But experience has shown us that such requirements are fairly uncommon and like the WRX STI will not be as highly demanded as its less-specialized brethren. For that reason, we will not be dedicating resources in advance to meeting those requirements as we are with the standard PODs.
Are the standard PODs for everyone and for every application? The answer is clearly “No.” But are there several applications for which the standard PODs work and work well for? Our experience tells us the answer is an emphatic “Yes” and that in the “we needed it yesterday” world we live in, there is a place for standard PODs. So, if you want a cleanroom that is high quality, fully functional and provided quickly, compromising one of those goals is no longer required. Buy the POD and get ready for delivery because it’s coming fast.
About the Author
Sid Backstrom is the Vice President, Business Management for G-CON Manufacturing, Inc. He functions in multiple areas overseeing Human Resources, Information Technology, Quality and Commissioning, Intellectual Property, and other areas including contract negotiations, partnerships, risk and insurance, regulatory, sales and marketing, management, company policies and procedures, etc. He has authored two book chapters and several papers related to the cleanroom industry. He is a Board Member and Secretary for the Texas Parenteral Drug Association. Backstrom has also provided consulting services to Gradalis, Inc., Strike Bio, Inc. the Mary Crowley Cancer Research Center, and several other related entities. He has sat on the Business Advisory board to Path4 venture capital firm based in Austin, TX, a firm that specialized in the Life Sciences musculoskeletal sector with a focus on early-intervention orthopedic solutions. Sid has a B.S. in Finance from Louisiana State University and a J.D.
also from Louisiana State University.