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Industry leaders are jousting with questions of how to quickly evaluate new and repurposed drugs while simultaneously readying their operations for rapid transformation. Novel partnerships between private R&D teams and public health agencies are emerging to address the “discovery” half of that equation, which leaves company leaders to grapple with the other half: how can they prepare their operations for commercial-scale manufacturing of a therapy that hasn’t yet been identified or approved?
The solution is a radically lean approach to capital project delivery. This approach relies on a multi-disciplinary team of industry experts, whose combined technical knowledge is rocket fuel for even the most complex projects. While your drug discovery activities continue, this team can get to work, quickly freeing potential throughput capacity in your existing operations and/or engaging trade partners in order to set a facility expansion initiative into motion. By initiating this lean delivery approach early in the process, you’re helping to ensure that when your COVID-19 therapy is ready for commercial manufacturing, your facility is ready, too.
Four key areas of priority
First and foremost, pharmaceutical manufacturers have four production priorities to help stop the spread, treat those affected and accelerate diagnosis.
The moment a promising modality emerges, speed is everything. The fastest-moving vaccine manufacturers will be those who understand how to leverage their existing capabilities to get more done, faster. If you already produce monoclonal antibodies, for example, you may be able to reconfigure your production equipment in synergy with your process development efforts, dramatically shortening the distance from clinical to commercial-scale vaccine production. The same could be true of your existing sterile finishing platforms, or your viral vector production equipment. Knowing how to reconfigure what is available in your production arsenal and scale it safely while rapidly deploying it in a GMP compliant way takes a nimble and responsive team of experts.
As the number of COVID-19 diagnoses skyrockets around the world, so does the demand for therapies that target its symptoms and protect those at high risk. Hyperimmune globulin (H-Ig), made from the donated blood plasma of patients who have completed their recovery, is a forerunner in this particular race. As in the case of vaccine production, the drug companies who’ll sprint across the finish line first have the foresight and agility necessary to repurpose what they already have.
Developers are also investigating the possibility of pivoting existing therapies from their original indications to target symptoms of COVID-19. For example, Gilead’s remdesivir treatment, originally indicated for ebola, is now in two Phase 3 clinical studies to understand its potential in improving lung function for patients with a COVID-19 diagnosis. The challenge that drug companies with reformulated COVID-19 therapies face is one of supply; what type of scale-out or scale-up strategy should they deploy in order to meet the skyrocketing demands of an unforeseen target population? Again, the solution lies in reconfiguring existing platforms in order to move as quickly as possible into commercial production once an effective modality emerges.
Diagnostic testing kits
In order to limit the spread of COVID-19, we need to better understand its population dynamics, which comes down to having the right diagnostic tools at the ready. The labs and facilities on the front lines of the COVID-19 offensive need to operate as efficiently as possible to meet this demand. For some, this means evaluating existing capacity in order to eliminate redundancies and improve operational efficiency; for others, it means expanding according to a carefully planned strategy.
What pharmaceutical leaders need to know
How can you make faster decisions, based on incomplete information?
To scale out or up, and to what degree? To manufacture in-house, or contract to a CDMO? When you don’t have the luxury of time—when you’re trying to expand your throughput capacity even before your drug discovery process is complete—answering these mission-critical questions can be very difficult.
You don’t need to find those answers alone. You have two sources of relief available: a library of existing data related to your particular challenge, and a partner who knows how to turn that data into decisive action. Whatever your production platform—cell culture, vaccines, plasma fractionation, cell & gene therapy, aseptic filling—you can bet that our team of experts has already worked out how to rapidly expand it, based on existing mathematical models, process flow diagrams, piping and instrumentation drawings, and other templated material. If you invite those experts to your table, you can leapfrog a lengthy stage of capital project development and get right to the business of operational expansion.
How can you identify spare capacity and pivot to productive use?
The fastest way to increase your throughput is by taking better advantage of what you already have. If you can do that, then you’ll uncork yourself from the bottlenecks that cripple other industry players, like long construction schedules and long lead times from equipment manufacturers.
To get there, you need to assess your “real” throughput potential. That means analyzing your unit operations, using process simulation to uncover opportunities for better efficiency and less waste. Changing a facility modality in rapid response to this pandemic requires risks to be eliminated to ensure supply chain certainty. Utility capacities, cold storage warehouse, labor and GMP testing capabilities must not introduce unforeseen risks to patients receiving a therapy.
How can you collapse our therapeutic delivery process to move quicker?
If you plan to scale out or up, in order to reach your target commercial volume, lean project delivery will help you move fast.
This means integrating design, engineering and construction teams and working with trade partners from the start to enable collaborative and quality-driven problem-solving. While you focus on development, this team of experts can focus on translating detailed process and facility planning into long-lead equipment procurement packages, which they will use to initiate high-quality offsite fabrication activities even before your product has been fully defined. This team can also work on accelerating regulatory approval by assembling preliminary documentation in lockstep with your facility’s evolution.
How do you navigate a collaborative partnership with BARDA and other health agencies?
The Biomedical Advanced Research and Development Authority (BARDA) is a key player in the offensive against COVID-19. Partnering with this agency and potentially leveraging existing BARDA sponsored facilities can be both an opportunity and a challenge for private drug companies. Test fitting a developed process into an existing facility and identifying potential capacity or compliance gaps requires world leading expertise.
These drug companies need a partner with the process expertise and BARDA experience necessary to quickly and effectively meet these demands, evaluate the facility fit and enable rapid product changeover in response to this pandemic.
At CRB, we’ve helped numerous clients respond to escalating health threats and rapidly changing market conditions. Whether you’re on the verge of a breakthrough COVID-19 vaccine or a novel treatment for those suffering its symptoms, chances are we’ve stood in your footsteps before, and have already mapped the fastest possible route between where you are today and where you need to be tomorrow.