Scientific research means any activities in the fields of natural or applied science for the extension of knowledge.
Research facility means buildings and structures, including machinery and equipment, used or to be used primarily for research or experimentation to improve or develop new tangible goods or materials or to improve or develop the production processes thereto. Manufacturing of Streptococcus pneumoniae Vaccine Candidate Process Establishment: We will generate a Research Cell Bank based on the cultures provided by Blue Water (Task 4). The upstream and downstream processing is similar between the different peptide constructs Blue Water will provide Research Cell Bank vials, reagents and standards and associated Certificates of Analysis, as required, to Ology Bio within 5 days of contract signing Information Transfer and Gap Assessment: The Information Transfer stage is critical for the success and timeliness of the project.Īll samples will be kept at room temperature and sent to the FHCRC Research Cell Bank, Eastlake Building, E1-305. The creation of the Research Cell Bank is now complete and manufacturing has been transferred to our dedicated biologics contract development and manufacturing organization Avid Bioservices, Inc. Once RH5 expression from the construct was confirmed, a Research Cell Bank (RCB) was generated by ES2B whereby Drosophila S2 cells were transfected with an RH5 expression vector and a stable cell line established.Īs presently designed, we believe the Terra CoV-2 vaccine permits cost effective storage and distribution at refrigerated temperatures, which should facilitate the distribution and thereby avoid challenges facing the two mRNA vaccines currently approved under Emergency Use Authorization in the U.S. Submission of draft toxicology reports during IND filing.Use of early pilot batch manufacture under Good Manufacturing Processes (GMP) for the anticipated Phase 1 clinical trials and,.Use of the Research Cell Bank in the early manufacturing process development.The broad support for our approach by the FDA included a number of activities, including: WuXi Biologics shall submit an invoice to Licensee for the License Fee within days after the date that WuXi Biologics completes Research Cell Bank generation from the Licensed Cell Line. Examples of Research Cell Bank in a sentenceĪs a follow-on to the successful production, testing, and selection of a CS protein expressing cell line under the original subcontract and Mod 2 which composed of : (i)-Evaluation of CSP expression (Stage 1), (ii)-Fermentation assessment of CSP (Stage 2), (iii)-CSP purification (Stage 2A/Mod 2) and (iv)-Preparation and characterization of Pseudumonas-CSP Research Cell Bank (RCB) (Stage 3), SAIC requires Pfenex to provide using the process established in Stage 2A.Īll blood samples will be kept at room temperature and sent to FHCRC Research Cell Bank, Eastlake Building, E1-305.
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