A long time ago and in another career, I had the opportunity to talk to an architect who had just won an award for designing a hotel that looked like a medieval castle. After I congratulated him his response was something like, “Thanks, but all I did was throw up a bunch of bricks and made it look nice.”
When designing pharmaceutical facilities, specifically modern pharmaceutical facilities, there is much to be taken into consideration – and merely throwing up a “bunch of bricks” (or steel, or concrete) just doesn’t cut it anymore.
As the industry has become more sophisticated so too has the need for engineering services firms to provide pharma companies with a wide range of services. Indeed many pharma companies are now looking for firms to provide them with facilities that are flexible, efficient and can produce quality products no matter where in the world they are situated.
We spoke to several engineering services firms to learn about the trends they are seeing in the industry and importantly what qualities you should look for when seeking engineering services.
What to Look For
When it comes to finding and vetting a potential engineering services firm for your project it is important to do your due diligence - just as you would with a home improvement project - research the company’s past projects, financial stability and talk to former clients. In addition, the engineering services firm should have knowledge of all related regulations, be versed in the latest technologies and understands strategic business goals. As Dave Goswami, PE, CEO/ Managing Director of IPS notes, “It is important that the engineering service company aligns with the business culture of the customer – the pharmaceutical company.”
“Anyone looking for a good firm should look at the legacy of their performance,” says Tim McNeill, Global Director of Technology at Fluor. “Make sure the com-pany is savvy on the latest technologies. Talk to previous clients.”
Finding out if your potential engineering services firm is well-versed in the latest technologies is one of the best ways to determine if a company is right for your project. “Experienced firms that are embracing new technologies like single use disposable applications to optimizing facility space and safety are key components in the biopharmaceutical industry,” says Chad Wisler, PE LEED AP, Principal at Vanderweil Engineers, LLP. He also says that having committed people to the project is another key to success.
The Biopharm Revolution
As the industry moves toward more biopharmaceutical production – the corresponding engineering needs of these biopharm companies is different from what tradition pharmaceutical companies have needed in the past.
“As a business strategy, you always have to meet current and future business demands,” says Goswami. “Yes, the products are changing regularly and affecting our service business. More biologics have not only created more market in biotechnology (Bulk Bio), it has also created a need for a lot more sterile fill facilities. Oncology drugs, which head the list of high-selling drugs, require cyto-toxic materials. This has created a need for potent compound handling expertise. New equipment technologies, such as continuous coaters, integrated systems, isolated fill lines, etc., have definitely affected our engineering services.”
“The change in the biopharmaceuticals market is in the pressure to not just focus on one product at a large scale but the requirement to manufacture multiple products and have the requirement to be flexible to change to the 'Just In Time' needs of the industry," says Wisler. “There is tremendous pressure on lower costs of facilities with shorter construction timelines. Companies are looking for an integrated team to address their capital needs with shorter construction schedules and more flexible use in their facilities. Biopharma companies are requiring their service companies to have a greater depth of knowledge on regulatory requirements and the ability to produce predictive models with advanced process controls.”
The Impact of Biosimilars
Just as the rise of generics forced traditional pharma companies to rethink their business models, so too will the advent of biosimilars force biopharm companies to change their business strategies. Biopharm companies do, however, have one advantage over their predecessors – the luxury of history. Regarding the imminent arrival of biosimilars many biopharm companies are preparing their facilities for more cost-effective production schemes.
“Big pharma was not as aggressive they should have been concerning generics – they didn’t see how much of the market place would be take away from them,” says McNeill. “We are seeing a significant push by traditional biopharma to not miss the opportunity to improve their offering, manage their portfolios flexibly or apply single use or barrier isolators to their facilities. For biosimilars there is a clear awareness that this could happen in the same fashion as generics and there is a much more aggressive approach to being market competitive now and taking advantage of technologies to make sure they are more cost-competitive.”
As engineering services firms are intimately involved in the designing, specifying, commissioning and validating of their client’s facilities they take a vested interest in making sure that the services they provide and the final outcome of their endeavors not only meet their clients expectations but those of all the applicable regulatory agencies.
Goswami offers his perspective. “Regulatory pressures, changes in regulations, and attempts to harmonize regulations in different countries as well as cost pressures have required our clients to relook at the way the business has been conducted in the past. As a result, clients are looking for engineering companies who can guide them through the latest regulations so that the facilities not only perform, but also conform. We also see a rise in the demand for lean manufacturing principles which can be applied to reduce cost of products.”
“What it comes down to now is that all the regulatory agencies produce guidelines – they are not specific directions,” says McNeill. “Each company has a different interpretation of those guidelines and we have to work within those considerations and with the agencies as they have their own interpretation. We work with every client to define the appropriate cGMP applications and produce facilities that are qualified and meet FDA expectations.”
“The pharmaceutical industry has very stringent regulatory and quality risk management requirements due to the high potency issues and workers safety requirements," says Wisler. "There are also greater increased drug development costs and lower R&D productivity that places pressure on this industry. The FDA is extremely influential in the US market, but there are also increased pressures from the European and foreign regulatory officials as many companies are more global than ever.”
As the industry continues to look for ways to save money, many things will come under scrutiny: operating costs, supply chain logistics and the ability to be flexible regarding individual products and portfolios of products, yet operate on a global scale
“A lot of pharma companies have examined their methods of production and their facilities and are coming to the same conclusions – they have to be cost-effective, they need to be global and they need someone to help them get there and do that,” says McNeill. “They are looking to simplify their whole capital project process. They need higher levels of standardization on designs and unit operations; resulting in a higher degree of consistency across supply chains so a facility that is making product in one country can make it exactly the same in another country – so their technology transfer is simplified and their time to market is simplified.”
IPS’ Goswami offers three points for the future, “In the near future, the industry will need three things from engineering service providers, first the industry will depend more on the A/E to supply state-of-the-art, cutting edge knowledge as operating companies continue to get lean in their organizational structure. The A/E will be asked to fill the void in the operating company’s organization through high level of consulting and technical expertise. Second, the expectations from A/E service providers to provide more flexible design that can be reused or repurposed by utilizing technology, modularization, out-of-the box thinking and other means will increase. And third and finally, bio-pharma clients will continue to look for innovative ways to get into business faster, i.e. the pressure to complete projects in a very short time line will continue to escalate.”