Biotech Boom Magnifies Biomanufacturing Capacity and Workforce Challenges
The ongoing pandemic response by the biopharma industry has been historic. Biotech companies and contract development and manufacturing organizations, along with the entire supply chain, have worked together to develop several SARS-CoV-2 vaccines, achieved Emergency Use Authorization(EUA) from the FDA, and began delivering desperately needed protection into people’s arms in less than a calendar year.
It has been a truly remarkable feat, of which the BioHealth Capital Region (BHCR) has been a driving force to fuel much of this astounding, groundbreaking work.
The pandemic has rapidly changed and revealed so much about our daily lives, the way we work, how we behave, and the strengths, weaknesses, and fault lines of society. Many of these revelations were unexpected and not always pleasant.
The same has been true for the Biotech industry. It too has had its strengths and pressure points brought into focus by this global health crisis.
The industry has been fundamentally and irrevocably changed by the pandemic. Biotech is now on the cusp of bringing forward radical transformation that could revolutionize healthcare, yet some challenges to achieving this have become more magnified as biopharma’s production and human capital infrastructure fight to catch up to the accelerating pace of scientific innovation.
Current Advanced Biomanufacturing Capacity and Talent Development Challenges
Where therapies sometimes took 10 years to commercialize, complex, effective vaccines sped through pipelines at record speed, creating new and exciting possibilities for what industry and government can accomplish when working together toward a common, urgent goal. However, these astonishing achievements have created new expectations for time to market, cost reduction, regulatory compliance, and good manufacturing performance, all while manufacturing demand for vaccines and cell and gene therapies is booming.
In some ways, biotech is having difficulty keeping up with its own stunning pace of innovation.
For example, in cell culture and bioprocessing, antiquated approaches are dying hard even though new automation and closed-loop systems are increasingly available and affordable. A workforce trained for the development of traditional biologics like monoclonal antibodies and common influenza vaccines needs to be recalibrated to handle cell and gene therapies and newer technologies like CRISPR. And a static, somewhat rigid manufacturing infrastructure that’s insufficient for current and future demand needs to be reimagined.
There are approximately 1,000 cell and gene therapies advancing toward commercialization right now; not all of these potential products will reach the market, but many will be approved in the near future. What’s more, COVID-19 vaccination manufacturing is producing hundreds of millions of doses, stretching manufacturing capacity extremely thin and even bumping other therapies out of production to accommodate vaccine demand.
Biotech companies and their contract development and manufacturing partners are already at capacity right now; production lead times of 16 months or more are becoming the norm, according to CRB’s recent Cell and Gene Therapy Report.
Biotech is booming, but can the industry meet this current and future demand? Will the automated technology, flexible advanced manufacturing capabilities, highly-skilled talent, and manufacturing capacity be there to deliver on the promise of great, innovative science?
These are deep questions that aptly apply to the BHCR, an advanced biomanufacturing hub that must grapple with these active talent and capacity challenges.
Today, we’ll take a deeper dive into the manufacturing capacity issue and potential solutions.
A Perfect Capacity Storm
According to CRB, a leading biopharma facility design-build company, there is a perfect storm of high demand, the need/expectation for rapid delivery, and continued reliance on antiquated, manual processes and technology that is putting significant pressure on manufacturing. And, when it comes to cell and gene therapies, personalization, adaptability, safety, and speed are must-haves that add even more pressure on an already stressed manufacturing ecosystem.
Experts cited by CRB predict that viral vector manufacturing will grow 20% year-over-year through 2025. That figure doesn’t even include other modalities like CRISPR and mRNA. Some experts predict that 10-20 gene and cell therapies will be approved by the FDA every year beginning in 2025.
A paradigm shift from what has been a research-based focus to a more flexible, automated, and commercial-facing approach is required to rise above these manufacturing demand obstacles. Increasing manufacturing capacity must be achieved if the industry and the BHCR are to continue thriving.
Increasing manufacturing capacity, agility, and in-house accessibility across the industry are deep and complex challenges. Yet solutions exist, as long as industry and the BHCR do what it takes to adapt.
The Past: The Success of mABS Shows Challenges Can Be Overcome
The ascension of monoclonal antibodies (mABS) to becoming approximately half of the biotherapeutics market was not smooth. This now booming therapeutic modality struggled early on with manufacturing and talent issues. Inconsistent runs, poor yields, and purification problems stunted growth for a time.
Ultimately, though, the biotech industry figured out best practices, streamlined processes, and found a way forward that reduced costs, increased scalability, and accelerated time to market.
In some ways, the current state of gene and cell therapy manufacturing mirrors the early days of mABS with one critical difference: cell and gene therapy manufacturing is more complex and difficult to scale due to intricate, delicate supply chain requirements and the personalized nature of these therapeutics.
It is difficult to apply lessons learned for mABS to what is required for effective cell culture/bioprocessing and the mass manufacturing of viral vectors, for example. What the success and ascension of mABS can tell the biotech industry is that manufacturing challenges can be overcome with ingenuity, investment, persistence, and collaboration.
The Future: Multi-modal Manufacturing Facilities
Forward-thinking organizations like CRB are rethinking what a life science facility should be, which is a flexible, agile, scalable, and efficient platform for delivering complex, variegated pipelines that can meet quickly shifting market demand.
CRB’s new approach to facility design is called SlateXpace and is one example of how the future of facility design is evolving rapidly.
This new multi-modal approach was designed to address current and future biotech manufacturing pain points. SlateXpace is a groundbreaking design-build solution for life science facilities. SlateXpace is a modular, multi-modal facility solution for the development and manufacture of Advanced Therapy Medicinal Products (ATMP) that offers life science organizations unprecedented construction speed, development flexibility, manufacturing adaptability, and budget control.
The SlateXpace design-build model is not only multi-modal, but it is also based on modular, prefabricated building processes. Building facility mods in a controlled, offsite environment enable higher quality construction and faster, more reliable project completion timelines that allow life science organizations to get up and running faster than ever before. The SlateXpace design-build approach empowers parallel construction of a facility core and shell while prefab mods are being built offsite, saving both time and money.
The benefits of SlateXpace for life science companies could be game-changing, allowing emerging biotech companies to scale strategically as their pipeline products advance through the development process. This ability to scale as the need emerges is critical to startups and emerging life science companies that often have more limited budgets in earlier phases of development.
Biotech companies are constantly weighing options to build their own manufacturing facility, outsource to a contractor, or even license/sell their product to a larger company with in-house manufacturing capabilities. Many emerging biotechs turn to CMO or CDMOs for production, but today, as we’ve discussed, lead times are 16-18 months, and many CMOs and CDMO’s report being at more than 90% capacity.
“We’ve brought on two new facilities, one in California that does cell processing and one here in Gaithersburg, Maryland that does viral vector manufacturing. We’re not even done building the Gaithersburg facility and we’re already booking manufacturing slots into the second quarter of 2022,” stated Mike O’Mara, Vice President of Industrial Business Services at Miltenyi Biotec, a global provider of products and services that advance biomedical research and cellular therapy.
“There are ongoing supply chain issues with materials and supplies also. The pandemic has caused a ripple effect that’s constantly shifting. Even before COVID, there was a supply chain crunch for single-use materials,” he added. “At Miltenyi, we’re advising our clients to reevaluate their clinical timelines because there are going to be delays. We’re working on new supply agreements to secure two to three years’ worth of materials to keep our clients on track.”
“We are developing these vaccines so fast, but we could do it even faster if we had access to more manufacturing capacity. The biggest bottlenecks we face as an industry to develop a second-generation COVID vaccine is lack of manufacturing infrastructure,” stated Vipin Garg, the CEO of Altimmune, who recently sat down for an interview with BioBuzz.
“We can do our trials faster if we had more space and materials available. One of the things we learned from the pandemic is that we can’t rely on overseas suppliers; the U.S. must be self-sufficient and create more manufacturing infrastructure to make our own drugs. This isn’t just about vaccines—any disruption in the supply chain like we’ve seen can affect any drug manufacturer,” he added.
SlateXpace, and other multi-modal, prefabricated facility designs will not eliminate the necessity of larger CMO and CDMOs, but they could be a major part of solving the capacity issue. This flexible, prefabricated, modular, multi-modal design-build approach could help more emerging biotechs become manufacturing-independent longer. Facility design approaches like SlateXpace could democratize adding in-house, highly flexible, and scalable manufacturing capacity without blowing tight budgets.
As the company succeeds, grows, and scales up, a SlateXpace facility can grow right along with these milestones, ensuring that investment and capacity always align with demand.
“The key aspect is the flexibility of the systems and the equipment within the facility. If you look back at traditional biotech over the last decade you have a lot of specific, custom-built facilities that would scale up rather than scaling out in footprint,” shared JP Bornholdt, Director or Technical Operations at SlateXpace and Facility Planning Specialist, Architect and Engineer at CRB.
“With SlateXpace companies now have the ability to start at a very small scale, maybe with just a few mods for preclinical work, and then expand these modules in a repeatable, scalable, and standard fashion that allows them to grow in a very natural and organic way without having to overinvest early. Startups and emerging companies often have little experience in capital projects and our approach reduces a good deal of risk for them.”
Reimagining what a biotech facility should be and democratizing manufacturing capacity is a first yet critical step toward resolving industry and BHCR manufacturing demand challenges. And creating the infrastructure to make the U.S. biotech supply chain more independent and self-sufficient is another.
In order to harness the power of this brewing tsunami of life science innovation, industry, and government entities need to come together, leverage what the COVID-19 vaccine process has taught industry, and accelerate investments in U.S.-based labs, state-side manufacturing facilities, workforce development, and a self-sufficient life science supply chain that can weather future disruptive events.
The cell and gene therapy wave is set to reach a crescendo in 2025. Will the BHCR and wider industry ride that wave, or will it crash? The technology, talent, and funding exist to ride that wave to new heights.
The question, then, is one of will, collaboration, and the convergence of biotech, industry leaders, governments, and workforce development programming to make good on the promise of scientific innovation.
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