Examples of Research Cell Bank in a sentence
As 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.
The prevention workforce consists of personnel directly involved in prevention of self-directed harm and prohibited abusive or harmful acts, with job responsibilities specific to prevention.
Control of materials Manufacture of turoctocog alfa Development genetics and cell banking system: The Applicant presented a sufficiently detailed description of the cloning procedure to generate the Research Cell Bank.
The selected strain will be used for establishment of a Research Cell Bank (RCB) and in parallel for manufacturing of a Master Cell Bank (MCB) and a Working Cell Bank (WCB).
As 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. 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.
Research Cell Bank, plasmid amplification (pDNA) at 20-30 L scale, Drug substance (mRNA) at 10-20L, bulk drug product (encapsulated mRNA) processes.
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.
The broad support for our approach by the FDA included a number of activities, including: ● Use of the Research Cell Bank in the early manufacturing process development;● Use of early pilot batch manufacture under Good Manufacturing Processes (GMP) for the anticipated Phase 1 clinical trials; and,● Submission of draft toxicology reports during IND filing.
Manufacturing of Streptococcus pneumoniae Vaccine Candidate May 21, 2020 Process Establishment: We will generate a Research Cell Bank based on the cultures provided by Blue Water (Task 4).
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.