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Cell and gene Therapy I GMP Manufacturing I Cleanrooms
Cell and Gene Therapy manufacturing is highly specialized, requiring strict adherence to GMP (Good Manufacturing Practice) guidelines to ensure therapeutic products’ safety, quality, and consistency…
CAR-T Therapy and GMP Manufacturing
CAR-T Therapy CAR-T (Chimeric Antigen Receptor T-cell) therapy is a groundbreaking immunotherapy that harnesses the body’s immune system to combat cancer. Unlike traditional treatments like…
Calibration of Temperature-Controlled Trucks and Trailers for GDP-Compliant Pharmaceutical Transport
Calibration of temperature-controlled trucks and trailers (used for GDP-compliant transportation of pharmaceutical, biopharmaceutical, and healthcare products) is a critical requirement under Good Distribution Practice (GDP)…
Building Monitoring Systems: Benefits, Regulatory Requirements, and Validation Strategies
Building monitoring systems (BMS) are essential tools for managing and optimizing the performance of building infrastructure. They offer numerous benefits and help ensure compliance with…
Building Monitoring Systems (BMS)
A Building Monitoring Systems (BMS) is an automated control system that monitors and manages a facility’s mechanical, electrical, and electromechanical services. Its primary purpose is…
Biosafety Cabinets
Biosafety Cabinets: Why Are They Required? Biosafety Cabinets (BSCs) are essential engineering controls in laboratories that handle potentially infectious agents or hazardous biological materials. They…
Biologics: Unlocking the Secrets of Biologics and Their Impact on Modern Medicine
Biologics I Applications I Regulatory Requirements I GMP Manufacturing Biologics have become a cornerstone of modern medicine, particularly in treating conditions that were once difficult…
Biologics: complex production, crucial for treatment.
Biologics manufacturing presents several challenges due to the complex nature of biological products. These challenges encompass various stages of production, from cell line development to…
Biologics Site Layouts
Designing a biologics facility involves creating a layout and process flow that ensures biologic products’ safe, efficient, and compliant production. The design of such a…
