Pharmaceutical firm and their R&D partners are under increasing pressure to produce results and new products quickly. When there’s a need to fast-track development, they might be called upon to add equipment and capabilities they don’t have on hand, nor do they have the time or money to build.
Enter on-demand facilities and equipment. With companies like consulting company Azzur Group helping connect clients with much-needed resources, R&D teams can get access to these resources only when they need them.
Outsourcing-Pharma (OSP) spoke with Christine Kressirer, senior director of operations for Azzur Cleanrooms on Demand, about the company’s services, and how on-demand solutions are helping meet the evolving needs of the industry.
OSP: Could you please tell us the “elevator description” of Azzur Group—who you are, what you do, key services and specialties, and what sets you apart from similar companies?
CK: Azzur Group is a service provider to the healthcare and life sciences industries. In terms of getting critical therapies to clinic, our company’s expertise spans the spectrum of discovery to delivery. Our service offerings are intended for a range of clients, from early-stage companies looking for a cleanroom space and manufacturing capacity, all the way to commercial companies that may need consulting, testing, calibration, training, and other services.
Our differentiator in the market is our breadth of expertise, from the discovery to delivery life cycle of critical therapies. Whether it’s early phase companies just getting into their first clinical batches or mature companies that are looking to expand, Azzur Group serves a wider market than most competitive consultants or CMOs; our Cleanrooms on Demand offering in particular is unique in the market for early-stage companies.
OSP: Could you please share your perspective on how the drug and vaccine development industry has evolved in recent years, especially how surging demand for therapies (and a need for speed) in certain areas has impacted CDMOs and other players?
CK: Over the last decade there's been a tremendous push in novel therapeutics, including mRNA, oligonucleotides and microbiome technologies. These novel therapeutics are so novel in fact that CDMO providers are faced with a shortage of talent with the expertise to understand and develop manufacturing solutions to support their clients’ needs.
Manufacturing these new therapies presents a two-fold challenge: Not just capacity but also capability. Some CDMOs may have the space but may not have the expertise or equipment because this aspect of the industry itself is so new.
This, combined with general lack of sufficient manufacturing capacity to support these novel therapeutics, has really positioned Azzur Group well within the industry. Our hybrid Cleanrooms on Demand model allows our clients to keep much of their expertise in-house, while getting to the clinic faster.
OSP: We’re about one year after COVID-19’s arrival. How has the virus, pandemic, shutdown and other events related to it impacted drug development?
CK: The biggest issue is the supply chain. A huge part of the domestic biopharma industry is supported by materials which originate from outside the US – China, India, and so on. Lead times have dramatically increased, whether for raw materials, buffer solutions, or infrastructure-related items like cleanroom panels.
As demand has skyrocketed, we’re seeing delays left and right, which have been exacerbated by COVID-19. The supply of these materials, already stretched thin because of companies working to solve the pandemic, has become a huge bottleneck. We’re experiencing some of these delays at our own facilities.
OSP: Could you please discuss some of the challenges CDMOs and other organizations face in the current, dynamic market? What needs and demands are they struggling to meet?
CK: The lack of expertise that we touched upon briefly earlier is definitely a challenge, especially for these novel therapeutics. The rapid innovation of technology the market is currently experiencing is leading to obsolete technology investments in established CDMOs.
Because of the lack of talent and expertise in the new technologies, there is also a strong need to provide robust training and development of staff. If you don't really know how to make or scale a batch, often through lack of experience, this becomes an inherent manufacturing challenge.
There is also a tech transfer bottleneck that often happens, which can take a significant period of time to complete. The client has to transfer the process knowledge, the science, and their intellectual property to the CDMO.
Now, in a very competitive market, if there’s a high rate of employee turnover among CDMOs (which absolutely happens), retraining becomes an issue as your company has to handle the knowledge transfer all over again. What’s more, early-phase companies often have to make process changes as they continue to characterize and develop their own processes; each of these issues adds additional time to the process, further reducing speed to market.
For companies that succeed or fail based on speed to clinic and speed to market, it’s important to reduce as many unnecessary complications as possible including the tech transfer time. The best way to do reduce these issues to keep the knowledge in-house.
OSP: Please talk about your Cleanrooms-on-Demand solution—who might be most interested in this service, and how does it work?
CK: Our ideal clients are early-phase companies transitioning into their first human trials. They are transitioning from research and development to GMP or process development to actual manufacturing batches, at scale, for human trials. Many have never gone through these processes before and it takes considerable knowledge and expertise to do this safely and efficiently.
Azzur Group’s Cleanroom on Demand model, therefore, is not just the cleanroom, but also all the expertise and services required – materials management, asset management, calibration, qualification, training, and so on. We have created the infrastructure for GMP compliance and quality management systems in our facilities, to accelerate the process for our clients. Intellectual property stays with the client, rather than having to be shared with a CDMO.
This speed to clinic concept is particularly important for the “fail fast” mindset that exists in pharmaceutical development. Because of the time, effort and expense related to development and manufacturing, companies like these would rather fail fast. After all, if a molecule is destined to fail, you'd want to know that sooner than later.
So that's where our model comes in. You can build your own facility or bring on a third party, but they both take time. Azzur Cleanrooms on Demand provides an interim solution to get the first set of batches into the clinics. We cater to the front end of the product development and commercialization life cycle.
As the product life cycle progresses through the clinical phases, these clients will eventually graduate from our facility to either later-phase CMO support or their own facility – or perhaps facilities that Azzur Group has designed for larger scale commercial batch manufacturers.
Most of our contracts are a minimum of one year. Based on client feedback, we currently support ranges from one to three years, with the option to extend further on the backend.
OSP: What other on-demand or temporary services do you offer CDMOs and other companies looking to add capacity or capability on a temporary basis?
CK: We offer many wrap-around services, including materials management – which is actually the biggest part of the day-to-day operations at any facility. Materials management includes everything from material procurement, receipt, quarantine to performing the quality release. We can support sampling and testing requirements for which we might bring in other Azzur Group services, such as Azzur Labs.
We also provide the option for clients to use our asset management services. These services provide direct client support for production of a GMP batch that may be outside our clients’ expertise, including installation, commissioning, qualification, equipment calibration, routine maintenance, alarm management, and so on. On an as-needed basis, we can provide document writing services, technical writing, IT and consulting services.
Many clients in this early phase may need some regulatory support, and we’re building up that service area as well. We provide training while they're onsite, but we can also provide custom training specific to their processes.
In short, we can offer almost anything the client needs except for the manufacturing itself. The client brings their science and manufacturing needs and we create the GMP envelope around it, so that they're GMP compliant and ready to go as they get into their clinical trials phase.
OSP: Is there anything you’d like to add?
CK: One common phrase that’s heard around the issue of manufacturing is “buy versus build.” Azzur Cleanrooms on Demand sits right between “buy” and “build.” We offer a practical middle ground, enabling companies either to be successful sooner or to fail faster, supporting early phase manufacturers until they grow enough to make their own buy or build decision.