Informējam, ka Sistēma pielāgota darbam ar interneta pārlūkprogrammu Internet Explorer (8. un jaunākām versijām) un Mozilla Firefox (3.6 un jaunākām versijām).
Izmantojot citu interneta pārlūkprogrammu, brīdinām, ka Sistēmas funkcionalitāte var tikt traucēta.
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>This document does not cover the selection, assessment or control of starting materials and excipients.</p>
<p>NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.</p>
Reģistrācijas numurs (WIID)
70982
Darbības sfēra
<p>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.</p>
<p>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.</p>
<p>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.</p>
<p>This document does not cover the selection, assessment or control of starting materials and excipients.</p>
<p>NOTE International, regional or national regulations or requirements can also apply to specific topics covered in this document.</p>
