Drawn by a biotech revolution taking place in Maryland, Azzur Group opened an office in Bethesda to handle the unique challenges facing biotech innovators across the I-270 corridor.
Azzur Group was founded in the Philadelphia region in 2010 as a GMP advisory and consulting professional services organization. Over the years the company has grown in scale and capabilities and saw the Maryland life sciences ecosystem as a great place to bring its unique approach to business. The organization offers its expertise to pharmaceutical, biotechnology, and medical device manufacturers to provide efficient and innovative solutions that will help those companies start, scale, and sustain their GxP organizations from discovery to delivery.
Tita Tavares, director of Azzur’s Washington, DC Practice, focuses her attention on companies in the region along the I-270 corridor and helps them to implement pharmaceutical manufacturing best practices related to GxP environments. Tavares provides support to clients by delivering technical solutions and advisory services based on current GxP, GAMP 5, ISO, and 21 CFR Part 11 regulations. The rapid growth of the greater Maryland area as a key biopharma hub in the United States drew the company’s attention, making it an important area for the company to establish a presence.
“It became apparent in 2019, that Maryland has the appropriate infrastructure, forward thinking, and drive to lead the Industry 4.0 revolution, making it the right state to be a part of,” Tavares said.
Azzur’s consulting business was founded in 2010 and the company has expanded to 12 offices in key biotech hubs across the United States, including three in the Mid-Atlantic region. In addition to the Bethesda office, Azzur also has offices in Philadelphia and New Jersey. The company draws on the expertise its employees have garnered in CQV, Regulatory and Quality Assurance Advisory services, process validation and verification, operational support services, and facility support.
Since the company’s founding, Tavares said Azzur Group’s leadership has made it a priority to listen to clients and their needs. In order to meet its clients’ requirements more fully, the company formed several new divisions to provide enhanced services for customers. In 2012, the company formed Azzur Labs, a full-scale microbiology and analytical laboratory. Azzur Labs provides pharmaceutical, biotech, medical device, and healthcare clients with a range of services including environmental monitoring, microbiology, analytical testing, chemistry, and cell and gene testing. Azzur Labs works in tandem with consulting clients to provide seamless testing and validation.
In addition to Azzur Labs, in 2018 the company formed Azzur Cleanrooms on Demand in order to support the need for early-stage clients who need GMP space to move from bench to batch. This company division offers on-demand ISO7/8 cleanrooms, materials management, building services, quality management systems, and wrap-around GMP support.
In 2021, Azzur Group also launched Azzur Training Center (ATC). Tavares said this division enables clients to become certified on the company’s techniques and then bring those protocols to ATC, which eliminated the need for facility shut down. Tavares said the cornerstone of Azzur’s specialized aseptic manufacturing concepts training is its 300 square foot ISO Class 5/7 cleanroom that provides hands-on aseptic gowning training courses to bolster a company’s techniques.
“Azzur strives to be another reliable resource of the invigorating, emerging life sciences ecosystem,” Tavares said.
She said operating in Maryland is exciting. With the presence of legacy pharma companies, as well as its startup culture, Tavares said Maryland has an intense energy that is “galvanizing opportunity, possibilities, and exponential growth” for life science companies, allowing them to respond to their critical missions.
“Azzur sees the advantages of the BioHealth Capital Region’s efforts of connecting venture capital funding, patents, and workforce creating the ideal biopharma cluster of impressive scientists, engineers, and business leaders that the needs of this world are calling for,” Tavares said.