The GxP expert has signed a Preferred Supplier Agreement with ODP through 2024 to help develop its Pharmaceuticals On Demand system
On Demand Pharmaceuticals (ODP) has signed a Preferred Supplier Agreement with Azzur Group through 2024. The transformation of ODP's Rockville Headquarters into a state-of-the-art cGMP Medicine Manufacturing facility began with Azzur in the fall of 2020.
Azzur collaborated in designing ODP's GMP Roadmap and helped develop the strategy and execution plan for ushering in this latest addition to Maryland's Biotech Hub. Building on the strategy, Azzur worked alongside ODP to initiate a Managed Services approach to execution, providing a single source for Commissioning services, Equipment rentals, Technology subscriptions, and a series of outsourced packages covering Environmental Monitoring, Training, and Documentation.
Dr John Lewin, ODP's Chief Medical Officer, said: "The flexibility Azzur demonstrated to accommodate the fluid nature of a startup and the challenges we all faced during the COVID-19 pandemic was remarkable. Having the ability to pull on a variety of resources and expertise, when we needed it, is the reason we entered this relationship."
Tita Tavares, the Director of Azzur Washington, D.C., said: "Enabling ODP to implement their innovative approaches required beginning with compliance in mind. Our unique approach to the Compliance Services world parallels ODP's strengths for innovation and delivering value to customers. At Azzur Group, we deliver the cGMP solutions required to address the greatest challenges life science companies face at every stage of their life cycle. ODP is on their way to filing their first regulatory submission and we look forward to our future efforts together."
ODP are developing its PoD (Pharmaceuticals On Demand) system. This is a rapid response capability system that can be quickly customised to produce anything from key starting materials to active pharmaceutical ingredients (API) and final formulated drugs. ODP is spearheading the development of automated and deployable PoD machines.
In the last few weeks, Azzur has also opened its fourth cleanroom facility event in Morrisville. Its three other current locations are in Waltham, MA; Burlington, MA; and Vista, CA. All have been selected for their proximity to established or growing life sciences business areas. (Morrisville is minutes from the celebrated Research Triangle area of North Carolina.)
The Azzur Cleanrooms on Demand business model came about in 2018, when Azzur Group’s client base in Cambridge encouraged the company to create cleanroom facilities in locations previously underserved with state-of-the-art GMP manufacturing capabilities. “Over these past years, we’ve helped advance the expansion of the life sciences industry in many fast-growing markets,” said Joel Gates, Senior Director of Operations, Azzur Cleanrooms on Demand Raleigh. “We’re proud to be doing the same in the Research Triangle area.”