According to a 2017 Nice Insight Contract Development and Manufacturing Survey, the top driver for pharmaceutical outsourcing is “access to specialized technologies.” For contract manufacturers, this need, paired with an ongoing focus on flexibility and containment, often results in a push to select equipment that is best-in-class in the industry.
“To put it simply, we need to have what clients will need to quickly and safely accomplish their goals in a finished dosage form,” says Shook.
FOLLOWING A ROADMAP
On its own, even the best-in-class equipment is not enough to enable facilities to juggle multiple products at once. Implementing new equipment and technologies requires a well-thought-out plan.
Sridhar Krishnan, vice president of Business Analysis & Excellence, responsible for Operational Excellence at Catalent Pharma Solutions, a global provider of drug delivery technology and development solutions with more than 30 global locations, stresses the importance of following a roadmap and progressing in a sequential order.
“Without understanding the process capability and limitations, automating the process does not make any sense,” Krishnan explains.
Catalent employs a seven-step process when it comes to implementing new technology. They focus on understanding process capability and optimizing each process step. Rather than rush onboard with new technology trends, they instead lay the groundwork for future technology and expansion, which also assures that facility space doesn’t need to be re-engineered after the fact.
We are investing proactively in areas but doing so in a very sequential way,” says Krishnan.
For example, when it comes to continuous manufacturing — an approach that has been heavily discussed in the industry for years but still has few real-world examples — Catalent is taking a methodical approach.
“We are not jumping the gun and buying fancy equipment. Instead we are using lean principles, optimizing the processes, putting semi-automated technologies in place and building the framework for continuous manufacturing,” notes Krishnan.
While it’s tempting to always be the first one out of the gate with new ideas, smart contract manufacturers are recognizing that properly preparing facilities for the future lessens the risk of failure when it’s time to launch new technologies.
DESIGNING FOR FLEXIBILITY
Planning ahead doesn’t just apply to technology implementation. Contract manufacturers are also meticulous planners when it comes to facility and suite design. Open spaces, modular equipment, and equipment on wheels — enabling plant floor operators to put together a new process train without engineers and mechanics — are common.
“Because you don’t know all your customers’ needs upfront, you have to design with flexibility and the capability to service their needs, not only from a GMP and quality perspective, but from a business perspective,” says Ken Domagalski, general manager at Avista Pharma’s Longmont, Colo. facility.
“Not designing facilities correctly upfront can cause major infrastructure issues down the road if you try to realign existing facilities to meet requirements,” adds Shook.
Avista’s recent investment in suite upgrades and capacity expansion at its Longmont site involved upgrading three existing GMP drug substance manufacturing suites and adding a fourth. In addition, Avista has also completed an expansion of new drug product manufacturing facility containing four flexible manufacturing suites for tablet and capsule manufacturing. Flexibility and containment were designed into the suites from the start. The
uites have unidirectional air flow patterns — a single pass, single direction air flow of parallel streams — which enables air to flow past potential obstacles with no risk of contamination from outside the zone.
“Each suite can be utilized for a different client at the same time, giving us ultimate flexibility, as well as containment,” says Shook.
To ensure that processes and systems were not only flexible, but also designed with containment and safety in mind, Avista enlisted the help of Safebridge Consultants — safety, health and environmental consultants who focus specifically on the pharmaceutical industry. Safebridge has been involved since pre-construction and Avista works with them on an ongoing basis to integrate suggestions and upgrades.
Emergent BioSolutions is also no stranger to the need for design flexibility. The company’s newly expanded Center for Innovation in Advanced Development and Manufacturing (CIADM) at its Bayview Campus in Baltimore is designed to support the U.S. Department of Health and Human Services’ strategic imperative to have “nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat.” Because of the government’s need to respond to biological and chemical threats, as well as emerging infectious diseases quickly and economically, the 112,000-square foot facility was designed to incorporate flexible, innovative manufacturing platforms that can be used to manufacture multiple products.
“We are working with ABEC to push the boundaries on single-use,” says Scott Battist, Emergent BioSolutions vice president, and general manager of the Bayview site. “Now, rather than incur the costs needed to ‘scale-out’ capacity with multiple 2,000-liter systems, single-use customers can achieve true economies of scale.”
“Ultimately, this has helped us to focus on agility and nimbleness and our ability to service a variety of customers with unique needs across multiple platforms,” adds Kirk.