As the institutionalized collection, storage, and distribution of bio-samples becomes more commonplace, the attention and adherence to strict and systematic sample handling practices is paramount. An important component of such efforts is the maintenance of bio-samples in a safe and controllable state (e.g., –80°C storage) apart from any downstream processes the samples could be subjected to in the future. CryoXtract Instruments’ CXT 750 Frozen Aliquotter provides repeated and reproducible access to a variety of frozen bio-fluid samples by maintaining samples at –80°C, thus eliminating undesirable freeze-thaw cycles during sample handling processes. The following study was performed by the Cincinnati Biobank Core Facility and the Center for Autoimmune Genomics and Etiology (CAGE) at Cincinnati Children’s Hospital Medical Center, in order to assess the feasibility of frozen aliquotting in conjunction with DNA extraction services provided by the Cincinnati Biobank. The Cincinnati Biobank planned and independently executed the experiment while CryoXtract’s role was to provide technical guidance running the CXT 750. Both groups participated in preparation of the manuscript…
Tag: <span>downstream processes</span>
Human granulocyte colony-stimulating factor (GCSF) is produced by biotech laboratories and production facilities for reducing neutropenia duration and sequels in patients with myelosuppressor treatments, among other applications. However, real challenges for these laboratories started in 2015 when the PEGylated-GCSF patent expired, opening alternatives for developing biomanufacturing processes and new applications. Thus, the purpose of this study was to analyze downstream process controls designed to ensure recombinant human GCSF (rh-GCSF) quality and to provide some evidence of the downstream process validation status. Study outcomes proved that the rh-GCSF expression system was stable and chromatographic profiles were reproducible among samples.