There are currently more than 3,000 advanced therapies in the development pipeline globally, along with 124 approved therapies. To enable this innovation and transformation of therapeutic options, Azzur Group today announces the introduction of analytical laboratory testing services for advanced therapeutic medicinal products (ATMPs).
The capabilities and expertise are built upon a foundation of safety, quality, and product stability to meet stringent regulatory requirements.
“When developing advanced therapeutics for patients, speed and compliance are critical. Expertise and time dedicated to method development, quality control testing, and validating analytical procedures are fundamental to success,” said Jorge Marques Signes, PhD, Vice President of Advanced Therapies Services. “The Azzur team is excited to enable industry pioneers in the delivery of novel cell and gene therapies that continue to not only change the course of medicine as we know it, but greatly enhance the lives of the patients who need it the most.”
With the introduction of advanced therapeutics testing services, Azzur Group has developed a new platform model that addresses the manufacturing infrastructure, processes, and application of expertise tailored to the specific demands of the pipeline lifecycle: fit-for-purpose and fit-for-phase, cost-effective, value-adding infrastructure support and scientific expertise. This solution includes Azzur Cleanrooms on Demand™, which combines manufacturing infrastructure, compliance expertise, and training without the burden of facility ownership. Azzur’s full suite of services provides a unique, unconstrained, and phase-appropriate GMP solution for cell and gene therapy development and manufacturing.
Azzur Group’s ATMP Analytical Services include assay and protocol development (compendial and non-compendial), study design and execution, and analytical/bioanalytical testing. For a full list of services and testing, visit Azzur.com/ATMP.
“It is our mission at Azzur Group to lead the charge in innovative solutions that enable our customers to progress science and innovation safely, compliantly, and efficiently,” said Sarah Stevens, PhD, President, Azzur Labs and Azzur Cleanrooms on Demand™. “The comprehensive Azzur approach to advanced therapeutics offers clients a model of speed and adaptability that will revolutionize manufacturing flexibility in the industry.”
