Jeff Shupack, President Advisory Practice, Project & Team11.09.21
Dr. Scott Gottlieb, the former Commissioner of the FDA, estimated that by 2025, as many as 20 or more cell and gene therapies will be approved each year.1 This surge in cell and gene therapy development will create huge opportunities for the pharmaceutical manufacturing industry, but it also presents some challenges that lab providers are already rising to meet.
Chief among those challenges is how to deal with the growing problem of insufficient laboratory space as the demand for new therapeutic manufacturing increases over time.
Facing a need for more space, funding, and more streamlined approach to pharmaceutical development, pharma manufacturers both large and small are being confronted with what is increasingly known as the “build versus buy dilemma.” They must choose between building laboratory facilities themselves or outsourcing development.
Both options come with challenges. Building a facility can take years, and can cost many millions of dollars. Outsourcing development means seeking the services of a segment of the industry that by many accounts has a waiting list of 18 months or even longer. In response to this challenge, a number of different solutions are emerging.
One avenue is the increasing availability of cleanrooms for hire. Providers of such facilities not only offer state-of-the-art laboratory spaces for development, but also provide a suite of additional services for start-up and fast-growing pharma companies. These services include support for good manufacturing practices, as well as materials handling and storage, and a host of other important operational capabilities.
On the other end of the spectrum, there is an emerging category of new laboratory providers that are using the Internet as a means of accessing fully equipped laboratory facilities remotely. By some reports, over a half a billion dollars of venture capital has been invested into these start-up facilities. This trend is allowing scientists and researchers to share experiments and findings with the highest levels of reproducibility, at a cost lower than the price of a single piece of laboratory equipment.
Make no mistake: For some companies, development of dedicated laboratories are still the preferred way of working, and flexible facilities (among other approaches) are a viable means of ensuring that a company can manufacture products at scale. For others, however, these alternative approaches allow a more level playing field with larger competitors.
Cleanrooms for hire: Enabling companies to “fail fast”
The “build versus buy” dilemma creates some very specific problems in the manufacturing process—specifically, it gets in the way of companies being able to “fail fast.”
Therapies need to be tested in laboratory situations, often several simultaneously, so that companies can know immediately which possibilities can be set aside and which should be fast-tracked for development. Without the appropriate lab facilities, that part of the process is not an option. This can be a real stumbling block for smaller, fast-growing businesses.
Besides the need to fail fast, many fast-growing pharma companies lack sufficient expertise in the operational competencies that larger companies take for granted—for example, Good Manufacturing Practices. For these businesses, being able to lease fully equipped laboratory space with complementary services will enable them to scale up without the need for major capital expenses.
One company at the forefront of the cleanroom leasing phenomenon is Azzur Group, with its Cleanrooms on Demand offering. The company has opened facilities in Waltham, MA, Vista, CA and Burlington, MA, with half a dozen or more opening throughout the U.S. next year. Its most recent facility in Burlington was at capacity before the official opening date; Moderna accounts for 75% of that capacity.
Ravi Samavedam, president and chief operating officer of Azzur Cleanrooms on Demand, explains that their offering “sits right between ‘buy’ and ‘build,’ as a practical middle ground. Our clients can either be successful sooner or can fail faster, allowing them to grow at a manageable rate until they’re financially ready to take on their own facility construction.”
Azzur Group’s ideal clients are early-phase companies, moving from R&D to GMP or process development to actual manufacturing batches, at scale, for human trials. The company’s Cleanroom on Demand model, therefore, offers more than just the cleanroom. It also includes all the expertise and services required to produce at scale—from materials management, to asset management, calibration, qualification, training, and more.
Azzur offers many “wrap-around services” as well, including support of sampling and testing requirements. The company also provides an asset management option, with direct client support for production of a GMP batch that may be outside clients’ expertise. On an as-needed basis, they also provide document writing services, technical writing, IT and consulting services.
By the company’s own analysis, this Cleanroom on Demand model can enable companies to get to market more quickly than when compared with CMOs or self-owned facilities. Anecdotal evidence suggests that speed-to-clinic using CMOs is typically a 6-12 month process, and a 12-24 month process in the self-owned laboratory environment. By comparison, some Cleanroom on Demand customers report requiring as few as 1-3 months for the same result.
For that segment of the market, Cleanrooms on Demand offer a considerable cost savings by eliminating capital costs, costs of tech transfer failures, schedule changes, and so on. Most Cleanroom on Demand contracts are a minimum of one year, with the option to extend further on the backend.
Cloud Labs usher in the era of “Science as a Service”
On the other side of spectrum, the power of the Internet is driving a whole new category of technological solutions to the “build versus buy” dilemma. Venture capitalists are investing hundreds of millions of dollars into the “cloud lab” concept, which aims to overcome the dilemma with offerings that provide fast, affordable and reproducible virtual laboratory testing at a fraction of the cost of either building a facility or outsourcing to a CRO.
Many companies offer fractional laboratory services in the cloud, or use the Internet for enhanced laboratory tools such as Electronic Lab Notebooks (ELNs) and Laboratory Information Management Systems (LIMS). Among the host of cloud lab offerings, however, Emerald Cloud Lab (ECL) may be the most comprehensive.
“Life sciences is finally beginning to realize some of the technological benefits of the Internet that other industries have reaped for years,” said Toby Blackburn, head of business development and strategy for ECL. “The cloud lab is democratizing access to a top-of-the-line laboratory environment, so that pharma companies don’t have to dwell so much on the problem of whether to buy a facility or outsource laboratory research.”
From a sprawling facility in South San Francisco comprising some 16,000 square feet, ECL hosts an automated laboratory featuring 190 different categories of research instruments. This state-of-the-art laboratory enables scientists to run virtually any standard research protocol, using a single piece of computer software. With an annual subscription that costs less than a typical lab instrument, researchers can send in their samples and code in their protocols, and ECL will run their experiments using semi-automated, high-throughput technology.
The company’s approach offers a comprehensive set of capabilities allowing researchers to perform all their basic cell biology and biochemistry experiments remotely—with the same flexibility they would have running experiments in their own lab. The environment is dynamic and virtually instantaneous. Once a researcher has an idea for an experiment and has signed up, they can have that experiment running within hours.
Users have a single digital platform, the ECL Command Center, from which they can design, execute, and interpret nearly any in vitro experiment without any previous coding experience.
ECL is focused on pre-clinical biopharma R&D research, from basic chemistry to cell biology. Clients recognize the flexibility, vast number of capabilities, efficiency, and the accessibility that ECL brings to their experiments. These client companies can reproduce their experiment with nearly push-button simplicity, which means they have more time to focus on their next experiment.
The benefit of using this cloud lab “Science as a Service” model depends on the maturity of the client. For example, pharma startups using ECL are likely to save on capital costs. Large pharmaceutical companies may be able to get to results faster with ECL. Academic scientists can use the cloud lab when they want to pose scientific questions that they cannot afford to answer using their currently available instrumentation.
Anecdotally, ECL clients have reported 300% to 700% improved productivity, with the ability to run multiple experiments simultaneously through the same cloud-enabled platform.
This way of thinking about “Science as a Service” may be a novel approach in the life sciences laboratory environment, but it’s familiar territory in the world of cloud-based technology. Emerald Cloud Lab’s business model is similar to that of most successful cloud-based ventures: Build once, sell many.
By providing a subscription-based service to clients at an affordable price, ECL can continue to update its own facilities more rapidly. This in turn enables the company to broaden its base of prospects, by offering an ever-evolving view of what a state-of-the-art facility looks like.
It’s a remarkable shift from the traditional approach to laboratory design and maintenance, in which a sizeable investment is made by an organization on individual pieces of laboratory equipment, which must then be studiously cared for until the end of their useful life expectancy.
Not a “one-size-fits-all” scenario for pharmaceutical manufacturers
What’s fueling these various laboratory models in pharmaceutical manufacturing? In short, it’s the various ways in which the visions of “lab solution” providers in the pharmaceutical industry align with deliberate approaches to cell and gene therapy development among manufacturers. And because manufacturing strategies differ, so too do the laboratory models. Consequently, the industry as a whole is demonstrating that there may be no “one-size-fits-all” scenario in modern laboratory innovation.
The rapid growth of new cell and gene therapies will continue to mark an acceleration in various lab scenario options to fit manufacturers’ needs. The above outlined scenarios demonstrate two successful options in how and where laboratory science can occur. Importantly, however, a common thread is emerging—labs and the companies that outfit them with equipment and instrumentation must be highly efficient, flexible, responsive, and capable of meeting ever-increasing capacity demands.
The increased focus on viable “build versus buy” solutions is an expression of the need to foster speed and productivity in bioprocessing, and pharmaceutical manufacturers dictate which scenarios make the most sense for their needs. There are many factors at play, including risk tolerance, number of products in development, timelines, existing infrastructure and more.
As mentioned at the outset, in some cases manufacturers will still want to maintain more control over their own facilities. To that end, the industry is responding by flexible or agile facility design.
Flexible facilities can pivot to meet new expectations, and allow for repurposing and expansion without significant or burdensome infrastructure changes that can threaten to interrupt ongoing operations. These companies need to understand not only their current needs but their future plans to create a design that can grow and scale with their production output.
For others—especially companies that may not have the same resources as more established pharmaceutical manufacturers—alternative laboratory offerings like those described in this article are creating a way to level the playing field in the booming years ahead for the cell and gene therapy market. They represent real innovation in addressing the pharmaceutical manufacturer’s “buy versus build” dilemma.
References
Jeff Shupack is the president of the advisory practice of Project & Team. He can be reached at hello@projectandteam.com, or through the company’s web site at projectandteam.com.
Chief among those challenges is how to deal with the growing problem of insufficient laboratory space as the demand for new therapeutic manufacturing increases over time.
Facing a need for more space, funding, and more streamlined approach to pharmaceutical development, pharma manufacturers both large and small are being confronted with what is increasingly known as the “build versus buy dilemma.” They must choose between building laboratory facilities themselves or outsourcing development.
Both options come with challenges. Building a facility can take years, and can cost many millions of dollars. Outsourcing development means seeking the services of a segment of the industry that by many accounts has a waiting list of 18 months or even longer. In response to this challenge, a number of different solutions are emerging.
One avenue is the increasing availability of cleanrooms for hire. Providers of such facilities not only offer state-of-the-art laboratory spaces for development, but also provide a suite of additional services for start-up and fast-growing pharma companies. These services include support for good manufacturing practices, as well as materials handling and storage, and a host of other important operational capabilities.
On the other end of the spectrum, there is an emerging category of new laboratory providers that are using the Internet as a means of accessing fully equipped laboratory facilities remotely. By some reports, over a half a billion dollars of venture capital has been invested into these start-up facilities. This trend is allowing scientists and researchers to share experiments and findings with the highest levels of reproducibility, at a cost lower than the price of a single piece of laboratory equipment.
Make no mistake: For some companies, development of dedicated laboratories are still the preferred way of working, and flexible facilities (among other approaches) are a viable means of ensuring that a company can manufacture products at scale. For others, however, these alternative approaches allow a more level playing field with larger competitors.
Cleanrooms for hire: Enabling companies to “fail fast”
The “build versus buy” dilemma creates some very specific problems in the manufacturing process—specifically, it gets in the way of companies being able to “fail fast.”
Therapies need to be tested in laboratory situations, often several simultaneously, so that companies can know immediately which possibilities can be set aside and which should be fast-tracked for development. Without the appropriate lab facilities, that part of the process is not an option. This can be a real stumbling block for smaller, fast-growing businesses.
Besides the need to fail fast, many fast-growing pharma companies lack sufficient expertise in the operational competencies that larger companies take for granted—for example, Good Manufacturing Practices. For these businesses, being able to lease fully equipped laboratory space with complementary services will enable them to scale up without the need for major capital expenses.
One company at the forefront of the cleanroom leasing phenomenon is Azzur Group, with its Cleanrooms on Demand offering. The company has opened facilities in Waltham, MA, Vista, CA and Burlington, MA, with half a dozen or more opening throughout the U.S. next year. Its most recent facility in Burlington was at capacity before the official opening date; Moderna accounts for 75% of that capacity.
Ravi Samavedam, president and chief operating officer of Azzur Cleanrooms on Demand, explains that their offering “sits right between ‘buy’ and ‘build,’ as a practical middle ground. Our clients can either be successful sooner or can fail faster, allowing them to grow at a manageable rate until they’re financially ready to take on their own facility construction.”
Azzur Group’s ideal clients are early-phase companies, moving from R&D to GMP or process development to actual manufacturing batches, at scale, for human trials. The company’s Cleanroom on Demand model, therefore, offers more than just the cleanroom. It also includes all the expertise and services required to produce at scale—from materials management, to asset management, calibration, qualification, training, and more.
Azzur offers many “wrap-around services” as well, including support of sampling and testing requirements. The company also provides an asset management option, with direct client support for production of a GMP batch that may be outside clients’ expertise. On an as-needed basis, they also provide document writing services, technical writing, IT and consulting services.
By the company’s own analysis, this Cleanroom on Demand model can enable companies to get to market more quickly than when compared with CMOs or self-owned facilities. Anecdotal evidence suggests that speed-to-clinic using CMOs is typically a 6-12 month process, and a 12-24 month process in the self-owned laboratory environment. By comparison, some Cleanroom on Demand customers report requiring as few as 1-3 months for the same result.
For that segment of the market, Cleanrooms on Demand offer a considerable cost savings by eliminating capital costs, costs of tech transfer failures, schedule changes, and so on. Most Cleanroom on Demand contracts are a minimum of one year, with the option to extend further on the backend.
Cloud Labs usher in the era of “Science as a Service”
On the other side of spectrum, the power of the Internet is driving a whole new category of technological solutions to the “build versus buy” dilemma. Venture capitalists are investing hundreds of millions of dollars into the “cloud lab” concept, which aims to overcome the dilemma with offerings that provide fast, affordable and reproducible virtual laboratory testing at a fraction of the cost of either building a facility or outsourcing to a CRO.
Many companies offer fractional laboratory services in the cloud, or use the Internet for enhanced laboratory tools such as Electronic Lab Notebooks (ELNs) and Laboratory Information Management Systems (LIMS). Among the host of cloud lab offerings, however, Emerald Cloud Lab (ECL) may be the most comprehensive.
“Life sciences is finally beginning to realize some of the technological benefits of the Internet that other industries have reaped for years,” said Toby Blackburn, head of business development and strategy for ECL. “The cloud lab is democratizing access to a top-of-the-line laboratory environment, so that pharma companies don’t have to dwell so much on the problem of whether to buy a facility or outsource laboratory research.”
From a sprawling facility in South San Francisco comprising some 16,000 square feet, ECL hosts an automated laboratory featuring 190 different categories of research instruments. This state-of-the-art laboratory enables scientists to run virtually any standard research protocol, using a single piece of computer software. With an annual subscription that costs less than a typical lab instrument, researchers can send in their samples and code in their protocols, and ECL will run their experiments using semi-automated, high-throughput technology.
The company’s approach offers a comprehensive set of capabilities allowing researchers to perform all their basic cell biology and biochemistry experiments remotely—with the same flexibility they would have running experiments in their own lab. The environment is dynamic and virtually instantaneous. Once a researcher has an idea for an experiment and has signed up, they can have that experiment running within hours.
Users have a single digital platform, the ECL Command Center, from which they can design, execute, and interpret nearly any in vitro experiment without any previous coding experience.
ECL is focused on pre-clinical biopharma R&D research, from basic chemistry to cell biology. Clients recognize the flexibility, vast number of capabilities, efficiency, and the accessibility that ECL brings to their experiments. These client companies can reproduce their experiment with nearly push-button simplicity, which means they have more time to focus on their next experiment.
The benefit of using this cloud lab “Science as a Service” model depends on the maturity of the client. For example, pharma startups using ECL are likely to save on capital costs. Large pharmaceutical companies may be able to get to results faster with ECL. Academic scientists can use the cloud lab when they want to pose scientific questions that they cannot afford to answer using their currently available instrumentation.
Anecdotally, ECL clients have reported 300% to 700% improved productivity, with the ability to run multiple experiments simultaneously through the same cloud-enabled platform.
This way of thinking about “Science as a Service” may be a novel approach in the life sciences laboratory environment, but it’s familiar territory in the world of cloud-based technology. Emerald Cloud Lab’s business model is similar to that of most successful cloud-based ventures: Build once, sell many.
By providing a subscription-based service to clients at an affordable price, ECL can continue to update its own facilities more rapidly. This in turn enables the company to broaden its base of prospects, by offering an ever-evolving view of what a state-of-the-art facility looks like.
It’s a remarkable shift from the traditional approach to laboratory design and maintenance, in which a sizeable investment is made by an organization on individual pieces of laboratory equipment, which must then be studiously cared for until the end of their useful life expectancy.
Not a “one-size-fits-all” scenario for pharmaceutical manufacturers
What’s fueling these various laboratory models in pharmaceutical manufacturing? In short, it’s the various ways in which the visions of “lab solution” providers in the pharmaceutical industry align with deliberate approaches to cell and gene therapy development among manufacturers. And because manufacturing strategies differ, so too do the laboratory models. Consequently, the industry as a whole is demonstrating that there may be no “one-size-fits-all” scenario in modern laboratory innovation.
The rapid growth of new cell and gene therapies will continue to mark an acceleration in various lab scenario options to fit manufacturers’ needs. The above outlined scenarios demonstrate two successful options in how and where laboratory science can occur. Importantly, however, a common thread is emerging—labs and the companies that outfit them with equipment and instrumentation must be highly efficient, flexible, responsive, and capable of meeting ever-increasing capacity demands.
The increased focus on viable “build versus buy” solutions is an expression of the need to foster speed and productivity in bioprocessing, and pharmaceutical manufacturers dictate which scenarios make the most sense for their needs. There are many factors at play, including risk tolerance, number of products in development, timelines, existing infrastructure and more.
As mentioned at the outset, in some cases manufacturers will still want to maintain more control over their own facilities. To that end, the industry is responding by flexible or agile facility design.
Flexible facilities can pivot to meet new expectations, and allow for repurposing and expansion without significant or burdensome infrastructure changes that can threaten to interrupt ongoing operations. These companies need to understand not only their current needs but their future plans to create a design that can grow and scale with their production output.
For others—especially companies that may not have the same resources as more established pharmaceutical manufacturers—alternative laboratory offerings like those described in this article are creating a way to level the playing field in the booming years ahead for the cell and gene therapy market. They represent real innovation in addressing the pharmaceutical manufacturer’s “buy versus build” dilemma.
References
Jeff Shupack is the president of the advisory practice of Project & Team. He can be reached at hello@projectandteam.com, or through the company’s web site at projectandteam.com.