Cell Bank definition

Cell Bank means a cell bank of vials with carrot cells producing taliglucerase alfa with information on its characterization and release, as well as information on its origin, plasmid, nature and sequence of the gene used, that is able to provide a sufficient number of vials for the production of the PRODUCT for a period time not less than 20 years.

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Cell Bank means Customer’s cell bank and/or cell stock of a rodent or human cell line in accordance with the Master Batch Record.

Cell Bank means either a master cell bank or a working cell bank, whichever the case may be in its use.

Examples of Cell Bank in a sentence

Cellares shall not transfer the Cell Bank or such finished Product (or other Partner Materials) to a Third Party or Affiliate of Cellares without Partner’s prior written consent.
After such [***] period, if Partner wishes Cellares to continue Cell Bank Storage or storage of finished Product (or other Partner Materials), such storage shall be subject to availability and, if storage is available, a mutually agreed storage fee will be charged to Partner.
Upon Partner’s prior written consent, Cellares may perform such testing of the Cell Bank or Product as mutually agreed by the Parties in accordance with the Quality Agreement for quality assurance, regulatory or safety purposes.
Any changes to such Cell Bank Storage or finished Product storage Services shall be made via an amendment to the applicable SOW as set forth in Section 3.2. If Partner does not timely pay all fees due for such storage, Partner shall within [***] of Cellares’ written notice arrange collection and shipping of the applicable Cell Bank or finished Product at Partner’s sole cost and Cellares shall not be obliged to continue such storage at the end of such [***] period.

More Definitions of Cell Bank

Cell Bank means a cell line that has been grown, aliquoted and stored under controlled conditions to ensure the sterility and genetic stability of the cell line.

Cell Bank means a facility that stores cells of specific genome for the purpose of future use in a product or medicinal needs.

Cell Bank means an aliquot of a single pool of cells which generally has been prepared from the selected cell clone under defined conditions, dispensed into multiple containers and stored under defined conditions.

Cell Bank means the cell banks to be established by Lonza or provided by Customer as described in the Project Plan. “Cell Bank Storage” means the storage of Customer’s Cell Bank in accordance with Appendix B of this Agreement. “Certificate of Analysis” means a document prepared by or for Lonza listing tests performed by Lonza or approved External Laboratories, the Specifications and test results. “Certificate of Compliance” means a document prepared by or for Lonza: (i) listing the manufacturing date, unique Batch number, and concentration of Product in such Batch, and (ii) certifying that such Batch was manufactured in accordance with the Master Batch Record and cGMP, if applicable. “cGMP” means any laws, regulations and regulatory guidelines, applicable in the United States, the European Union, and any other countries the Parties may mutually agree upon in writing, including but not limited to Japan, relating to the manufacture of medicinal products for human use (together with amendments thereto), including (without limitation) current Good Manufacturing Practices as specified in the ICH guidelines and, in particular (without limitation), ICH Q7A “ICH Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”, the US Federal Food Drug and Cosmetic Act at 21CFR (Chapters 210, 211, 600 and 610, 820), the Rules Governing Medicinal Products in the European Union (Eudralex), Volume 4 in particular - without limitation- Part I (for Drug Products) and/or Part II (for APIs) as promulgated under the European Union Directives 2001/83/EC and 2001/20/EC and European Commission Directives 2003/94/EC and 91/356/EC; European Medicines Agency Note for Guidance CPMP/ICH/4106/00; the US FDA 21 CFR 210/211/600, and 21 CFR part 11 and 610; and other agency regulations and regulatory guidelines as applicable in the agreed- upon jurisdictions to API manufacture. For the avoidance of doubt, ▇▇▇▇▇’s operational quality

Cell Bank means the collection of vials containing the Cell Line.

Cell Bank means, with respect to a Cell Line, the cell stock of such Cell Line.

Cell Bank means, with respect to a Collaboration Program, the various master, working and other cell banks that comprise a Development Candidate developed by or on behalf of Century in connection with such Collaboration Program.