Cell Bank Timeline Generator Master and working cell banks provide a foundation for the production of your product for years to come. Start planning early to make sure you can have these cell banks made, characterized, and available to keep to your internal timelines. This interactive tool gives you insight into estimated timelines required for production and characterization, allowing you to plan your cell banking program timelines. Simply fill out the form below to see a timeline tailored to your scenario. First Name * Last Name * Title Company * Email * Type of Bank * -Select- Mammalian Microbial Cell Line* Select the type of bank above Please fill in cell line Are your cells in suspension or adherent? * -Select- Suspension Adherent RCB Available Date (date when RCB vial can arrive at Charles River) (or) Bank release date requested Have you performed GxP sterility, B&F (bacteriostasis and fungistasis), and myco (mycoplasma) testing on your RCB and can you provide reports for this testing? * -Select- Yes No Would you like an engineering run performed prior to your GMP cell bank production? * -Select- Yes No Do you have a vaccine product or would you like to perform in vivo testing that complies with both FDA and EP guidelines? -Select- Yes No Have you already planned for your required viral clearance study? * -Select- Yes No Do you need your product release and stability assays developed/qualified/validated? * -Select- Yes No Yes, I would like to receive email communications from Charles River and allow for my information to be used for any follow-up requests to identify potential products or services relevant to my needs. I agree. * required Please note that this interactive tool is meant to provide an estimated timeline to help you better plan your cell banking program. Charles River is not committing to these dates at this time. Actual milestone dates would have to be confirmed by contacting us. W - Weeks Start date End date RCB Submission Date Pre-Bank Option #1 (expansion, testing and engineering run) 10 Pre-bank expansion and testing (sterilty, mycoplasma) 8 Engineering Run 9 Batch Record Finalization and Sign Off 3 Option #2 (Pre-bank testing with expansion of samples necessary (no engineering run)) 8 Pre-bank expansion and testing (sterilty, mycoplasma) 7 Batch Record Finalization and Sign Off 3 Option #3 (Client Provides Sterility and Myco Reports and would like to do engineering run 10 Engineering Run 7 Batch Record Finalization and Sign Off 3 Option #4 (Client Provides Sterility and Myco Reports - no engineering run) 5 5 5 Batch Record Finalization and Sign Off 2 Option #1 (Testing and Engineering Run) 6 Pre-bank testing (bacteriophage, purity and identification) 4 Engineering Run 3 Batch Record Finalization and Sign Off 3 Option #2 (Pre-bank testing) 5 Pre-bank testing (bacteriophage, purity and identification) 4 Batch Record Finalization and Sign Off 3 Option #3 (Client Provides pre-bank reports and would like to do engineering run) 5 Engineering Run 3 Batch Record Finalization and Sign Off 3 Option #4 (Client Provides Sterility and Myco Reports - no engineering run) 3 5 5 Batch Record Finalization and Sign Off 2 Cell Bank Manufacturing Microbial Cell Bank Production 1 1 1 Mammalian Cell Bank Production 3 3 3 Release Testing Mammalian - including sterility, myco and viability (includes vial expansion times) 8 8 8 Viability 2 Expansion 3 Sterility Testing 3 Mycoplasma Testing 5 Final Review of Cell Bank Package 1 Microbial - including purity, bacteriophage testing, viability and ID 4 4 4 Bacteriophage testing 2 Purity and Viability 4 Identification 3 Final Review of Cell Bank Package 1 Cell Bank Released with Certificate of Analysis Further Characterization Studies *+ Mammalian (10-12 weeks)*+ 10 11 11 Identification 4 TEM 8 In vitro mycobacteria testing 10 In vitro adventitious virus assay 6 In vivo Adventitious Virus Assay Testing (covers vaccines and cell lines)** 10 Bovine/Porcine Adventitious Viral Agents 6 PCR-Based Reverse Transcriptase Assay 3 Viral PCR Panel (specific panel is dependent on cell line species) 3 Gene Copy Number 7 Sequence confirmation 8 Restriction Endonuclease analysis 8 Identification 4 TEM 8 In vitro adventitious virus assay 6 Extended In vitro Focus Induction Assay for Xenotropic Murine Leukemia Virus 6 Extended XC Plaque Assay for Murine Leukemia Virus 6 In vivo Adventitious Virus Assay Testing (covers vaccines and cell lines)** 10 Mouse Antibody/Hamster Antibody Production Testing 8 Porcine/Bovine Adventitious Viral Agents 6 PCR-Based Reverse Transcriptase Assay 3 MVM viral PCR 3 Gene Copy Number 7 Sequence confirmation 8 Restriction endonuclease analysis 8 Identification 4 TEM 8 In vitro adventitious virus assay 6 Extended In vitro Focus Induction Assay for Xenotropic Murine Leukemia Virus 6 Extended XC Plaque Assay for Murine Leukemia Virus 6 In vivo Adventitious Virus Assay Testing (covers vaccines and cell lines)** 10 Mouse Antibody Antibody Production Testing 8 Porcine/Bovine Adventitious Viral Agents 6 PCR-Based Reverse Transcriptase Assay 3 Gene Copy Number 7 Sequence confirmation 8 Restriction endonuclease analysis 8 Identification 4 TEM 8 In vitro adventitious virus assay 6 In vivo Adventitious Virus Assay Testing (covers vaccines and cell lines)** 10 In vitro mycobacteria testing 10 PCR-Based Reverse Transcriptase Assay 3 Porcine/Bovine Adventitious Viral Agents 6 Viral PCR Panel (specific panel is dependent on cell line species) 3 Gene Copy Number 7 Sequence confirmation 8 Restriction endonuclease analysis 8 Identification 4 TEM 8 In vitro adventitious virus assay 6 In vivo Adventitious Virus Assay Testing (covers vaccines and cell lines)** 10 Spiroplasma testing 4 Porcine/Bovine Adventitious Viral Agents 6 PCR-Based Reverse Transcriptase Assay 3 Gene Copy Number 7 Sequence confirmation 8 Restriction endonuclease analysis 8 Identification 4 TEM 8 In vitro adventitious virus assay 6 In vivo Adventitious Virus Assay Testing (covers vaccines and cell lines)** 10 Porcine/Bovine Adventitious Viral Agents 6 PCR-Based Reverse Transcriptase Assay 3 Gene Copy Number 7 Sequence confirmation 8 Restriction endonuclease analysis 8 Microbial (6-8 weeks)*+ 7 7 7 Retention of Selectable Markers 4 Retention of Recombinant Construct 5 Plasmid Sequence Confirmation 7 Copy Number 7 Restriction Endonuclease Analysis 8 Retention of Recombinant Construct 5 Plasmid Sequence Confirmation 7 Copy Number 7 Restriction Endonuclease Analysis 8 Retention of Recombinant Construct 5 Plasmid Sequence Confirmation 7 Copy Number 7 Restriction Endonuclease Analysis 8 Further characterization studies complete Start date End date * Clients may choose not to perform all of this testing or to add additional testing to their program. ** Timeline may be shorter depending on the protocol used. + Timelines below start after cell bank is released. Some clients may choose to start the characterization test "at risk" before the cell bank in released. askcharlesriver@crl.com www.criver.com © 2015 Charles River Laboratories International, Inc.