INTERPHEX 2016: From the Ground Up – Facing Pharma/Biopharma Facility Challenges Head-On

In 2014, the global pharmaceutical market topped $1 trillion in sales, with the world’s 10 largest drug companies generating $429.4 billion of that revenue.¹ It is approximated that $100 billion is spent on biomedical research in the U.S. each year. In addition, many of the pharmaceutical companies claim that each new drug they create costs approximately $1.2 billion, though some industry experts believe the cost is closer to $60 million.

According to an article in Bizmology:

“The aging of manufacturing facilities, which are sometimes operated past their expected life span of 20-25 years, is one of the major factors that have led to these [drug] shortages. Upkeep and modernization efforts are quite costly, and if the drugs being manufactured aren’t very profitable, the likelihood that production will be curtailed rises.”²

Working to combat these issues, companies often hire consulting firms that specialize in technical operations and suggest ways to save money—often using nontraditional technologies that lengthen the life of a manufacturing facility. But making adjustments to a facility or its operations is a balancing act when it comes to determining whether or not regulatory approvals are necessary, particularly since an investigation by regulatory authorities result in production delays.

As many of you well know, building a new pharmaceutical facility, or restructuring/expanding one, is incredibly expensive. With the creation of new drugs costing approximately $5 billion, the construction of the buildings in which these drugs are made is certainly not going to be friendly on the wallet nor simple to design.³One company estimated that projects typically fall in the range of $500,000 to $60 million.⁴

As new innovations and industry trends, such as single-use technologies, process automation, and cGMP facility designs become the new normal, the once complicated process of designing a new facility or updating a currently-existing facility becomes even more involved—with that many more choices for a company to make prior to launching into construction.

Several companies have joined forces and are endeavoring to address this industry challenge.

The Klyo Collaborative, an alliance of companies experienced in the biopharmaceutical industry, seeks to remove barriers that previously required companies to manage multiple partners in order to achieve desired facility outcomes.

The companies participating in the Klyo Collaborative are:

Rockwell Automation (pharma manufacturing products)
The Beck Group (construction firm—products)
Holtz Biopharma Consulting (consulting)
EEA Consulting Engineers (engineering company)
McDay (strategic marketing)
CBR International (regulatory compliance)
Laurus Bio, LLC (biologics manufacturing)

One of the companies participating in the collaboration, The Beck Group, a leading architectural construction firm, has a technology division, Beck Technology. This division created DESTINI Profiler—a technology created specifically for facility design

“It’s an estimating tool for pre-construction, estimating construction budgets, and looking at multiple scenarios of how to build buildings,” said Barry Holtz, Ph.D., Principal Consultant at Holtz Biopharma Consulting.

Having a grasp on financial expectations as well as capital expenditure is critical for companies—specifically biotech companies—looking to understand how laboratory work translates to real-world scenarios.

“I’ve been working on life science projects for over 28 years, and I have been going through the painful process of re-budgeting and estimating new facilities. It’s important to understand the need from a client’s perspective: the sooner you can get a product to market, there’s a lot of advantages (not only economical but also on the development process of the new product),” said Jose Rivera, P.E., Project Executive of Life Sciences at The Beck Group. “When I joined Beck, they already had this amazing tool. We can address this issue . . . in a very visual way.”

Life sciences are heavily involved in equipment and processes, and DESTINI Profiler, as a tool, has been revved up to be utilized specifically in life sciences.

The amount of data that has to be gathered for life sciences can be one of the biggest challenges, according to Rivera, particularly since it is changing on a daily basis.

“We are working with many equipment manufacturers so we can get the latest data information and latest cost into the database for D-Profiler,” said Rivera. “And you can visualize all of this on a 3-D model.”

“Working in 3-D should never be underestimated,” added Holtz. “One of the things you see when you’re building facilities is you realize very few people can extrude a building in their head from a flat drawing. . . . So being able to look at things in 3-D and then move walls around and do what-if scenarios is very visually important for scientists, process development people, and other people not strictly involved in architecture.”

Other companies, such as Intergraph Process, Power & Marine (PP&M), have also jumped on the 3-D bandwagon, utilizing this popular technology in the modeling and visualization of a pharmaceutical facility.

“The big game changer is the timeline has gotten so much earlier with this tool,” said Susan Stipa, President of McDay, adding that they can be involved earlier in the planning stages.

Most pharmaceutical facilities take years to build (or to reconstruct an existing facility). Pfizer’s API manufacturing facility in Tuas, Singapore, for example, was built over a period of three years (2001-2004). Though, many facilities often take much longer than that—including both the planning and construction phases.

“We can actually model the processes very early in the game,” explained Holtz, “and put those into context of a hypothetical building and look at the impact on capital expenditure as we go through the process development project.

“Very few processes stand on their own. They always have to be supported by utilities, raw materials, people—and have space.

“If you can take these pieces and put them into the context of a new building and look at what some of the decisions are early on in unit processes and what their effect is on the CapEx [capital expenditure], it even gets more exciting.”

Depending on the pharmaceutical facility owner’s expertise/background, they often bring some key background information to the planning of the pharmaceutical facility, explained Brent Pilgrim, Director of Services of The Beck Group’s Beck Technology division. The manufacturing process, for example, is critical—the information of which will often commingle with the rest of the project information.

“Clients have their own standards and own way of doing things,” said Rivera. “There’s always a learning curve—what is the basis of their design and trying to guide that information.”

This includes the finishes, the equipment arrangement, as well as the specific manufacturers/vendors who they prefer to work with.

Despite the ease of process that technologies such as DESTINI Profiler might provide, there are always going to be challenges that companies face when delving into a project on such a large scope.

“One of the biggest challenges is to get companies to make a decision,” said Holtz. “Decision-making is paralytic in biotech for some reason. Companies face financial pressures, but they also face product delivery pressures.

“A lot of biotech companies are partnered with other companies or they’re in competitive situations where they need to be the first to market. But getting them to actually pull the trigger—to build a facility and commit to it—is the thing I find the most interesting. Even though they have all of these opportunities and all of these people knocking at the door, it becomes paralytic internally to pull the trigger because they’re designing buildings by committee. They don’t bring in expertise early enough because everyone thinks they know how to design their own building and process—me included. But I’ve learned that to bring people in early and often who you can count on to give you a model and a price and a structure that works allows you to make that decision.”

It is hard to get to the decision point, added Holtz, because you are always leaving something undone that the professionals know how to do.

“One of the reasons why they are so slow to make decisions is [because of] the fear of making decisions made on bad data,” said Pilgrim. “Without properly vetting out assumptions which have to be made at an early phase, you run the risk of making bad decisions on bad data. And certainly that would paralyze anyone putting that much money into an investment.”

“The biggest challenge I see,” said Rivera, “is return of investment.”

Many of the biotech facilities receive funding from other companies, such as Big Pharma, and it can be difficult to show the return of investment to their investors, explained Rivera.

“How many biotech facilities in the last 10 years have you seen that claimed they were on time and on budget?” asked Holtz. “Very few.”

Holtz, along with Geoff Middleton, Architect, cGMA, Inc., John Gilroy, P.E., SVP & Principal, IPS-Integrated Project Services, and David Marks, PE, President and Principal Consultant, DME, participated in the INTERPHEX Live panel titled “Overcoming Facility Upgrade Challenges” at the Crystal Palace in the Javits Center in NYC.

References

“Big Pharma.” Drug Watch. https://www.drugwatch.com/manufacturer/.
Ramirez, Diane. “Aging Manfacturingg Facilities Worsen Global Drug Shortages.” Bizmology. 2015. http://bizmology.hoovers.com/drug-shortages-create-opportunities/.
Herper, Matthew. The Cost of Creating A New Drug Now $5 Billion, Pushing Big Pharma To Change. Forbes. http://www.forbes.com/sites/matthewherper/2013/08/11/how-the-staggering-cost-of-inventing-new-drugs-is-shaping-the-future-of-medicine/#6b607fc96bfc.
“Pharmaceutical.” GBA Builders, LLC. http://gbabuilders.com/market-pharmaceutical.html.