Web Content Management

PRODUCTS

  • Germfree-Gene Therapy
    Cleanrooms And Equipment For Gene Therapy Drug Manufacturing

    Delivering on the promise of cell and gene therapy

    Germfree is a leader in creating mobile and modular facilities specifically for cell and gene therapy (CGT) manufacturing. As CGT sits at the crossroads of medical research and pharmaceutical development, it demands highly specialized cleanroom designs. These designs must focus on efficient workflows, strict separation procedures, and rigorous aseptic processing to ensure the best results. Despite the quick growth and logistical challenges in the CGT field, Germfree’s mobile solutions effectively tackle these issues. They enable distributed manufacturing, ease the collection of patient cells, and help make CGT treatments accessible globally.

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    Get Phase-Appropriate CMC Support

    Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval.

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    Achieve Efficient Viral Vector Production At Any Phase

    The Challenge: Building Scalable Viral Vector Programs

    Cell and gene therapies offer unprecedented hope for previously untreatable diseases. At the heart of many of these advanced therapies, including both gene therapies and gene-modified cell therapies, are viral vectors, particularly Adeno-Associated Vectors (AAV) and Lentiviral Vectors (LVV), which serve as crucial gene-delivery vehicles.

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    Pharmaceutical Change Control Software

    Using Document Change Control Software in Regulated Environments

    Change is important in any business, but it is especially critical in life science, manufacturing, and other regulated companies, which are required to "control" change as part of compliance. This is why many companies are turning to document change control software to help them address the complexity of change control.

    In regulated environments, the term "document change control" may refer to the document management or document control process, or it may to refer to the change control process, which involves rigorous documentation. Either way, most companies need document change control software to manage these processes.

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    Regulatory Sciences

    We want your product to move through the regulatory process, gaining approvals and ultimately helping patients. Using our industry leading knowledge and skills, we will meet you where you are – gaining approval: for the first in human trials, in development, at scientific advice, at the end of phase 2, or post approval. At every level, our scientific expertise and in-depth knowledge of therapeutic backgrounds have guided every client we have to a successful outcome.

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