Provider of Global Contract Research Services Accelerating Preclinical Research, Drug Discovery & Therapeutics Altogen Labs 4020 S Industrial Dr Suite 130 Austin TX USA Services > Cell Banking A cell bank is a facility that stores cells of specific genome for the purpose of future use in a product or medicinal needs. They often contain expansive amounts of base cell material that can be utilized for various projects. Our GLP-compliant cell line banking systems provide the stable mammalian cell population required for production, assurance that a uniform population of cells is preserved, cell integrity is maintained, and cells are readily available per customer request.

Commitment to Quality Facilities Altogen Labs maintains our cell line banks in a secure, controlled and monitored storage environment. Cell banking work is performed within certified Class II laminar flow biosafety cabinets with HEPA filtered air. Cells are grown only in calibrated incubators with UV air and water protection. Quality Control Altogen Labs’s cell-banking process is GLP-compliant, with established SOPs and associated cell line batch records. Cell lines are certified to be free of mycoplasma or bacterial contamination. Cell growth and Cryopreservation Altogen Labs performs cell expansion to manufacture a cell bank using standard T-flasks, roller bottles, shake flasks, and cell factories. Our cryopreservation service is performed in a monitored liquid nitrogen system. We can ship the cell bank on dry ice directly to the client worldwide or to a specified third party.

Details of Service Altogen offers master cell bank services as well as working cell bank services. Cell lines that originate therapeutic producing cells, created through transfection, screening and cell expansion can be preserved through cyrovials and maintained as a master cell bank. At a later stage, such as during development or manufacturing, a working cell bank can be used that involves producing cells from the master cell bank and growing these cells for several passages and cyropreserving the cells.

Cell Banking Service: Master Cell Bank (MCB, WCB) Generation Creating a cell bank is a vital element in producing uniform biological products. Cell banking systems are set up to assure that a uniform population of cells is preserved, their integrity is maintained, and a sufficient supply of material is accessible for the life of the product. Biosafety testing ensures a homogenous cell bank and screens for mutations and contaminations. Testing includes the following: Sterility and PCR testing for viruses Contamination testing for virus, fungi or mycoplasma DNA fingerprinting and sequence verification of vector constructs During the development of cell lines expressing monoclonal antibodies, expression vectors or recombinant proteins, a clone is used as a source to produce a master cell bank (MCB). MCBs are critical to the early phase of therapeutic development and manufacturing during clinical and commercial phases. At Altogen Labs we follow an industry-standard two-tiered cell banking system in which the MCB is expanded to produce a working cell bank (WCB) for everyday laboratory use. The MCB/WCB system is critical for scale up manufacturing of therapeutic producing cells and is used for later phases of therapeutic development. Altogen Labs services include a comprehensive environmental monitoring program, as well as production of cell banks appropriate for cGMP studies. We also offer cell-banking services for in- market supply production or late phase study.

Cell Banking Service: Master Cell Bank (MCB, WCB) Generation Master Cell Banking: Cells that produce therapeutic antibodies or other molecules of interest are created through the introduction of expression constructs and vectors into the genomes of cell lines from a variety of species, including human cells, other mammalian cells, insect cells and bacteria. These cells are typically modified through gene transfection or transformation, followed by selective screening processes in which the expression or inhibition of biological characteristics (protein expression, mRNA transcription, etc.) are used to identify potential gene-expressing cells. Once identified, these cells are used to create a MCB and are cryopreserved to eliminate contamination, biological degradation and genetic variation. The cell lines are also passaged as little as possible prior to cryopreservation (in duplicate vials) to minimize potential contamination and genetic variation that may occur during handling. Working Cell Banks: Working cell banks are usually necessary for later stages of development and manufacturing of potentially therapeutic cells. Usually, the WCB is produced by expanding a single vial of the MCB that has been characterized for viability and has been passaged several times. There are a number of MCB and WCB already available at Altogen Labs, including: Insect Cells Mammalian Cells Rodent Cells

Cell Banking Service: Master Cell Bank (MCB, WCB) Generation Monitoring and Security Altogen Labs offers long-term storage of cells in a secure, controlled, and monitored environment. Cell banking work is performed within certified Class II laminar flow biosafety cabinets with HEPA filtered air. Cells are grown only in pre-calibrated incubators with ultraviolet (UV) air and water protection. Cell banks are divided and stored in separate freezers to prevent loss due to freezer malfunction. A monitoring system confirms proper liquid nitrogen levels and freezer temperatures around the clock. A fully redundant backup system ensures security of the storage facility. We certify that cell lines are free of mycoplasma and bacterial contamination. Cell bank (or individual cryovials) shipment Altogen Labs uses material as needed by client specifications. Altogen Labs can ship the cell banks directly to the client or to a specified third party, or to any destination worldwide.

Cryopreservation and Cell Banking Service (GLP-compliant) Cryogenic storage at ultra-low temperatures is a recognized mechanism for providing indefinite longevity to cells; however researchers have observed variability in the quality of preserved cells when samples were kept at different frozen temperatures. Generally, liquid nitrogen at -196°C is required to successfully preserve the complex biological structures of a cell and to virtually stop all biological activity. Use of a single cell line in continuous culture for research or manufacturing purposes can be problematic due to the possibilities of microbial contamination, loss of required characteristics, genetic drift, and overshoot of the finite life span of a cell line. Maintaining separate working cell banks and cryopreserved master cell banks allows the client to utilize a consistent supply of cells with low passage numbers, free from contamination and stable for expression of desired characteristics. Maintenance of a master cell bank is crucial for development of therapeutic products through all phases from clinical development to commercial supply.

Cryopreservation and Cell Banking Service (GLP-compliant) Altogen Labs complies with regulatory guidelines to ensure that all procedures, practices, and facilities conform to GLP standard. All cell lines are certified free of mycoplasma and bacterial contamination. Our protocols use suitable combinations of cryoprotectants and cooling regimes to guarantee successful cryopreservation of biological materials, cells, and tissues including stable cell lines, cells for transfusion, umbilical cord blood cells, stem cells, and tumor/ histological cells. Altogen Labs offers long-term cell storage of cells in a secure, controlled, and monitored environment. Cell banking work is performed within certified Class II laminar flow biosafety cabinets with HEPA filtered air. Cells are grown only in calibrated incubators with ultraviolet (UV) air and water protection. Banks are divided and stored in separate freezers to minimize the risks of a freezer malfunction. Liquid nitrogen levels and freezer temperatures are monitored 24 hours per day, 7 days per week with a special monitoring system. We ensure the security of the storage facility with a fully redundant backup system. Cryovials can be used to expand a cell population, or can be shipped directly to the client or to a specified third party. We ship cells on dry ice to any destination worldwide.

Flowchart of Services Altogen performs mycoplasma and sterility testing to ensure no contaminants Evaluation study Master Cell Bank and Working Cell Bank produced based on needs Character- ization studies performed Altogen offers long- term storage of cells in a secure environment Altogen Labs services include a comprehensive environmental monitoring program, as well as production of cell banks appropriate for cGMP studies. We also offer cell- banking services for in-market supply production or late phase study.

Provider of Global Contract Research Services Accelerating Preclinical Research, Drug Discovery & Therapeutics Altogen Labs 4020 S Industrial Dr Suite 130 Austin TX USA Services > Cell Banking Cryopreservation Cell Banking Service: Master Cell Bank (MCB, WCB) Generation Master cell banking Working cell banking Monitoring and Security Cell bank (or individual cryovials) shipment Biosafety Testing Methods Sterility and PCR testing for viruses Contamination testing for virus, fungi or mycoplasma DNA fingerprinting and sequence verification of vector constructs Altogen Labs can ship the cell banks directly to the client or to a specified third party, or to any destination worldwide.