The Future of Facilities

Over the next decade, pharma manufacturing will have to evolve. Facilities haven’t changed substantially in more than a generation even as regulatory scrutiny and the need to minimize risk has increased dramatically.
Current facility design can be improved to reduce manufacturing costs, improve quality control, eliminate shortages, enhance compliance and reduce risk.
But it’s going to take more than upgraded equipment to make real progress. The answer may be in embracing disruptive technologies and approaches, moving away from batch-based systems to a continuous manufacturing approach.
When it comes to continuous manufacturing methods, Novartis is a world leader, thanks to the Novartis-MIT Center for Continuous Manufacturing, a 10-year $50-million research project designed to transform pharmaceutical production.

With continuous manufacturing, which has already been adopted in other sectors, requires more automation, which should reduce production errors and improve quality control. It’s more efficient because all the ingredients – for example, the tree bark, water, etc. – are gathered in a single production line at one end, and the finished pill comes out the other. This is in contrast to combining ingredients processed by different partners and shipping to a finish dosage manufacturer. Continuous manufacturing, which is becoming available and is built to a GMP standard, requires a smaller physical footprint, which also helps it be more environmentally friendly option.

Making the move to continuous manufacturing has some risks. Building a continuous manufacturing line may cost millions – and a company’s annual revenue and profit margins may not to justify the level of investment. Further, while the FDA is encouraging the industry to embrace new technologies, regulators haven’t addressed how they would approve continuous manufacturing. (By the way, continuous manufacturing benefits the FDA, too, because it wouldn’t have to inspect multiple facilities – just one machine.)

That said, between current batch-based systems and continuous manufacturing, manufacturers have to make some decisions to remain competitive and in compliance. The path forward is to integrate new processes into the current processes, in part by embracing modular technology.

The following questions are designed to help plan for the halfway step between current systems and what could be the future of continuous manufacturing.

What will your Quality by Design (QdB) initiative need to achieve? It’s not enough that your QdB program can handle today’s challenges. We all need to think about steps to take to increase efficiency and effectiveness while meeting regulatory scrutiny that will continue to increase. Audit your current program and consider how to address changing reporting requirements, and the impact of using risk-based assessments.

  • What direction is the FDA giving about accepted approaches regarding the adoption of new technological advances? Operating in a highly regulated industry, manufacturers are understandably reluctant to make moves that require substantial investment and operational changes without guidance from the FDA. Even if you’re not planning to initiate any near-term changes, make sure to monitor the latest guidance from the FDA. You can also consider checking with the FDA to clarify regulatory expectations because you don’t want to be the company that discovers a previously unknown issue.
  • What do you need to have in place from an equipment, personnel, supply, etc. to develop a strategy that provides long-term solutions to quality control and drug shortages? A lot of us focus on the day-to-day but good pro-sports GMs always think ahead about what pieces they need to field a competitive team a few years down the road. That’s something all good pharma manufacturers need to do: develop a multi-year plan, and execute against it. For example, you may need to update employee training programs and supplier relationships.
  • What technologies and processes will you need in 2020 to succeed? Some of the goals in the future should probably include enhancing efficiency, reducing waste and lowering risk. Your QMS may be adequate right now but it may not be able to handle future demands. The FDA has found that QMS failure has resulted in product recalls, drug shortages and other issues that led to lost revenue, damaged reputations, lost jobs and in some cases, the loss of the company itself. Continuous manufacturing – long embraced in other industries – may be an approach to consider.
  • Do you have enough manufacturing capacity? When looking at capacity, keep in mind that not all capacity is equal. You may need to expand cGMP capacity but not necessarily increase the number or size of your reactors. Some additions may require dedicated equipment used to fulfill specific process needs while others may need flexible technology that can work with different drugs. Modular technology may help you address capacity needs but companies need to clearly define their needs before placing the order. And continuous manufacturing requires a dramatic rethinking of a facility.
  • What can you afford to change and do you need to change your business model? Clearly that’s a critical question, especially for smaller manufacturers. The costs to make substantial changes can be hard to justify unless you’re making blockbuster products – but the cost of not innovating could be the future of your company. To make it work, your company may need to alter its business model. As it is, many companies are moving away from the traditional business, including labs, even an office – they are outsourcing everything, with one firm making the API, another to formulate it, yet another to handle the IND, animal testing, QA and another partner for the clinical trials. There’s a lot of opportunity to adjust your business model.

 Once you’ve decided how to plan for the future, it still makes sense to let big pharma lead the way. They’re the ones with deep pockets and generous margins from blockbuster drugs that can afford the financial risk. Apply their lessons, as appropriate, to your situation.

The upside of re-imagining the future of pharma manufacturing is the possibility of reducing the $2.5 billion and the decade of development to bring a drug to market. More than that, new approaches may be able to reinvigorate R&D to produce more new molecules that can be developed into good medicines, helping patients and pharma companies.