Sentence examples for gmp procedures from inspiring English sources

The preparation of MSC differentiated into osteogenic lineage for clinical use requires the fulfillment of strict good manufacturing practice (GMP) procedures.

The peptide was synthesized, purified, bottled and lyophilized according to GMP procedures (batch 01FS019, RMF Dictagene SA, Epalinges, Switzerland) and tested for stability and toxicity (sterility, endotoxin content, apyrogenicity) as well as for immunogenicity in mice when formulated with adjuvants cited below.

All procedures were conducted under a laminar flow, following strict rules of asepsis and sterility in a cell processing center, according to the GMP procedures.

Although FACS sorting is considered a non-GMP procedure, its safety with new sorters is comparable with that of clinical-grade immunomagnetic sorting.

The aim of this work is to verify the predictability of alginate capsules for large-scale production by Good Manufacturing Practice (GMP) standardized procedures in a cell factory.

Following GMP-compliant procedures, we generated a stable clonal cell line expressing a humanized CAR based on ErbB2-specific antibody FRP5 harboring CD28 and CD3ζ signaling domains (CAR 5.28.z).

However, the development of GMP-compliant procedures that ensure consistent isolation and expansion of NK cells that retain their potency as well as the safety of the final product for the patient remains a major hurdle [ 21].

Tracers for in vivo use were prepared in GMP-compliant procedure using a fully automated synthesis module (Scintomics GmbH, Germany) similar to the procedure described previously [33].

Radiolabelled [11C]HED was synthesized according to a GMP-compliant procedure (licence nr. 108879 F), using a modification of the method of Van Dort and Tluczek [28].

68Ga-labeling of DOTATATE and HA-DOTATATE (5 nmol) was carried out in a fully automated, GMP-compliant procedure using a Scintomics Gallelut+ module (Scintomics, Fürstenfeldbruck, Germany) [11,12].

Synthesis of [68Ga]Pentixafor was performed on a fully automated, GMP-compliant procedure using GRP module (Scintomics GmbH, Germany) equipped with disposable single-use cassette kits following the previously described method [5, 6].