On-demand cleanrooms help pharma manufacturers ‘fail fast’
Trial and error is a necessary part of successful drug manufacturing and development efforts. However, the sooner an operation can get through that stage (especially the error part of the phase), the more quickly it can reach success.
To learn more about how the cleanroom-on-demand concept can help accelerate the process of trial and error, Outsourcing-Pharma spoke with Dan Dernbach, senior vice president of global operations with Azzur Group.
OSP: Please tell us a bit about Azzur Group—who you are, what you do, key capabilities, and what makes your company unique in this space.
DD: A nationwide network of companies delivering professional services across the life sciences industry, Azzur Group is dedicated to providing customers with practical and proven solutions from Discovery to Delivery. Azzur Group has more than 250 industry partners, including 80% of the top pharma/biotech manufacturers in the US.
As one of the fastest growing privately held companies in America, Azzur Group provides customers with the project management, consulting, facility solutions, engineering, validation, IT, training, and laboratory services they need to remain innovative and competitive.
OSP: Why does the cleanroom-on-demand concept appeal to drug developers, manufacturers, and other professionals in drug development/production?
DD: The main appeals of the cleanrooms-on-demand model are speed, service, and flexibility. Within a short period of time, our client partners can be in our cleanrooms manufacturing. They do not need to wait months to years for the CDMO pipeline to have availability.
Additionally, with all the wrap-around services we offer and our expertise in GMP compliance, our partners can focus solely on the science, which is their expertise. Finally, there is flexibility. They can adjust or pivot their processes as needed. Our clients remain in complete control of their IP and process.
OSP: Did the COVID-19 pandemic impact the industry’s interest in your company’s services? Please discuss.
DD: The COVID-19 pandemic brought a number of issues to the forefront. The first is the lack of available manufacturing space for clinical products. Second, is the value of speed in the drug development process. Third, is the need for flexibility in the developmental pipeline.
All of these impacted our cleanrooms-on-demand business. Companies were calling daily looking for a GMP environment to develop their therapeutics and vaccines. So many companies shifted focus to COVID-19 response and needed additional space for development and manufacturing. Fortunately, we were able to work with several.
By using our facilities and services, companies could rapidly enter manufacturing, or fail fast and pivot accordingly. They did not have the luxury of waiting for the CDMO pipeline. They were able to work within weeks, cutting months off the development timeline.
Finally, the flexibility we offer clients by allowing them to control their manufacturing process and pivot as needed allowed them to work through a multitude of vaccines and therapies in a short period of time. COVID-19 was an ever-evolving target; by being able to pivot quickly and change their development timeline without long tech transfer processes, our clients were able to quickly and efficiently develop therapeutic and vaccine candidates.
OSP: Could you please talk about the concept of “failing fast,” and why this is especially beneficial in the drug development and manufacturing field?
DD: No one likes failure, but it is a part of therapeutic development. Not every molecule is successful. By helping our cleanrooms-on-demand clients accelerate their manufacturing, a fail/forward decision can be reached much more quickly.
If a molecule fails, the flexibility of our model allows our partners to pivot immediately. The failure decision and ability to respond to it comes at a much earlier stage, saving valuable time and money. Our clients do not need to re-queue in the CDMO pipeline. They control their own manufacturing and can immediately begin working on an alternate molecule.
OSP: Please tell us about any new locations or services you have in the works that OSP readers might be interested in learning.
DD: Azzur Group is rapidly expanding to meet the needs of our clients in major pharmaceutical and biotech hubs throughout the United States. In addition to our existing COD facilities in Waltham, MA; Burlington, MA; and San Diego, CA, Azzur has planned expansions in Raleigh, NC; Alameda, CA; and Devens, MA; with further expansions planned in 2024.