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Cell and Gene Therapy

GXP GUIDANCE FOR THE INDUSTRY’S MOST NOVEL DEVELOPMENTS

The U.S. Food and Drug Administration (FDA) predicts that by the year 2025, they will approve 10- 20 cell and gene therapy (CGT) products per year
That’s up to 35% of the total number of therapies approved annually by the FDA today. Unlike traditional pharmaceutical or biotech manufacturing, you face a myriad of challenges with the time-sensitive nature and patientcentric manufacturing of cell and gene therapies. From apheresis to patient administration, Azzur Group is with you every step of the way to ensure a safe and effective product for your patients.
REGULATORY GUIDANCE
 
Unlike the stringent outlines for pharmaceutical manufacturing, regulatory guidelines within the CGT space are just that: guidelines for control to ensure quality and patient safety. Therefore, you’re left to interpret the guidance and implement it in a manner that mitigates your specific risks while improving patients’ lives.

Backed by decades of experience immersed in a culture of quality, Azzur’s qualified GxP consultants, engineers, and scientists work side-by-side with your team to assess processes and develop comprehensive, risk-averse, and appropriate quality control methods and documentation practices. We also manage a regulatory guidance database based on our years of experience that gives your team an edge over the competition.
 
APPROPRIATE INFRASTRUCTURE
 
Today, you’re facing the burden of multi-phase manufacturing, patientspecific lots, and personalized quality control, all while accounting for a number of external factors. And, while enterprise manufacturers are fortunate to have existing facilities at their disposal, start-ups face a hurdle when it comes to capital expense and appropriate infrastructure.

With Azzur Cleanrooms on Demand™ (COD), we provide cGMP operations space with uncompromised access and control for your team. Our model affords you the ability to rent manufacturing space, storage space, and equipment, while assuring you and your team can oversee the entire process, reducing risk and protecting your sensitive intellectual property.
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TIME TO TREATMENT
 
In their current state, patients undergoing CGT often are at a late or timecritical stage of relatively high-risk disease. Your cycle time and time to treatment could mean the difference between life and death. Until manufacturing is streamlined across your organization and standardized cGMP practices are in place across all approved treatment sites, the risk of delay remains an issue.

With trusted experts and laboratories throughout the country, as well as turnkey training programs, Azzur Group can manage your delivery-site audits, qualifications, and validation so that your patients can get the care they need when they need it.
 
TRAINING
 
Positive patient outcomes with CGT lay in the highly specialized skill-set of developers and those administering treatment. To date, the burden has been on you to train personnel at approved sites in the proper manufacturing, handling, and administrative techniques required for safe and efficacious treatment.

Together with your team, Azzur Group develops comprehensive classroom-style, kinesthetic, and/or electronic training curricula to qualify all staff so that you can grow your list of qualified manufacturing and administrative sites.
Cell and Gene Therapy Services
  • Azzur Cleanrooms on Demand™
  • Validation and Verification
  • Compliance
  • Engineering
  • Labs Services
  • Training
  • Regulatory Guidance Database
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