This document specifies general requirements and reviews the points to consider for the transportation of cells for therapeutic use, including storage during transportation. Transportation starts from the transfer of the packaged cells by the sender to the transportation service provider and ends when the package is delivered to the receiver at its destination. This document does not apply to transportation of cells within one facility. This document includes the development of a transportation plan including verification and validation, communication between the client and the transportation service provider, and associated documentation. This document does not specify particular conditions for transportation such as specification for shipping container, ambient temperature control, etc.

  • Standard
    19 pages
    English language
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  • Standard
    19 pages
    English language
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This document specifies definitions and general requirements for ancillary materials (AMs) used in cell processing of cellular therapeutic products. This document is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document does not cover the selection, assessment or control of starting materials and excipients. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

  • Technical specification
    10 pages
    English language
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This document provides guidance for ancillary material (AM) suppliers to maintain a high level of lot-to-lot consistency in the aspects of identity, purity, stability, biosafety, performance, as well as the accompanying documentation. This document is applicable to cellular therapeutic products, including gene therapy products whereby cells form part of the final product. It does not apply to products without cells. The AMs described in this document include those of biological origin [e.g. sera, media (including media additives), growth factors, and monoclonal antibodies] and chemical origin. This document does not address dimethyl sulfoxide (DMSO) for cryopreservation, beads, scaffolds, feeder cells, apparatus and instruments, or additives used post bioprocessing. This document does not cover the selection, assessment or control of starting materials and excipients. NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.

  • Technical specification
    11 pages
    English language
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This document provides guidance for ancillary material (AM) users. It is applicable to cellular therapeutic products, including those gene therapy products whereby cells form part of the final product. It does not apply to products without cells. This document focuses primarily on ancillary materials (AMs) of biological (human and animal) origin and their potential impurities and contaminants. NOTE 1 The decision chart in Figure 1 illustrates the rationale underlying the scope of this document. However, diverse biological sources, including plants, insects and marine organisms, can also be used in the development of a cellular therapeutic product. Therefore the fundamental principles of risk management also apply for these sources of AMs. This document does not cover the selection, assessment or control of starting materials and excipients. However, it is anticipated that these are still covered by general risk management procedures. This document is applicable for users at all stages of clinical development and supply; however maximum benefits can be gained by the implementation of the recommendations in the early stages of development. NOTE 2 International, regional or national regulations or requirements can also apply to specific topics covered in this document.

  • Technical specification
    11 pages
    English language
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