Compliance

PRODUCTS

  • Ensuring the integrity of results and maintaining regulatory compliance are paramount concerns for any lab today, especially with increasingly complex laboratory processes. Cloud-based device management offers several advantages for laboratory equipment monitoring.

  • The LabAlert™ wireless laboratory monitoring system is designed to provide secure, real-time oversight of critical lab equipment and environments. This cloud-based platform enables centralized monitoring of temperature, humidity, and CO₂ levels across single or multiple facilities, with customizable alerts delivered via web or mobile app. The system supports FDA 21 CFR Part 11 compliance and eliminates manual data logging with secure, centralized recordkeeping. Easy to install and scalable, LabAlert also includes tools for preventative maintenance tracking and cost management.

  • Delivering on the promise of cell and gene therapy through Germfree products and services.

    Germfree Laboratories offer advanced modular and mobile facilities, equipment, and comprehensive services for cell therapy manufacturing. Acknowledging the complexity of personalized treatments, Germfree’s adaptable solutions optimize production processes, ensuring aseptic conditions, scalability, and compliance with regulatory standards. This enables efficient, high-quality cell therapy delivery to patients in need, supporting manufacturers in overcoming industry challenges.

  • Navigating the technical challenges of mAbs production and scalability

    Monoclonal antibodies (mAbs) offer promising immunotherapy treatments, targeting antigens and diseases. Manufacturing these complex therapies presents challenges in scaling up, cost, and consistency. Germfree’s expertise in tailored cleanroom solutions addresses these obstacles, ensuring sterility and seamless equipment integration. By providing advanced facilities for both small-scale clinical trials and larger-scale production, Germfree contributes to the successful development and commercialization of mAbs, ultimately improving patient outcomes and transforming healthcare landscapes.

  • IntegriCell™ cryopreservation services from Cryoport Systems optimize leukapheresis-derived cell therapies by enhancing the safety, quality, and viability of manufacture-ready cryopreserved leukopaks. Our state-of-the-art cryopreservation process, integrated with our end-to-end global temperature-controlled supply chain platform, provides unmatched reliability, efficiency, and scope. Our standardized protocols meet the highest compliance standards, ensuring consistent quality and addressing product stability issues associated with fresh donor-derived cellular material for an optimized approach that enhances manufacturing efficiency and streamlines operations.

WHITE PAPERS AND CASE STUDIES

NEWS