Altogen Labs CRO Services:
Cell Banking and GLP-compliant Master Cell Bank (MCB and 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 is performed on cell lines at multiple passages.
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
Following the introduction of cell lines expressing monoclonal antibodies, expression vectors or recombinant proteins, clones are used as seeds to produce master cell banks (MCB). MCBs are critical to the early phase of therapeutic development and manufacturing during clinical and commercial phases. At Altogen Labs we follow a two-tiered cell banking system in which the MCB is expanded to produce a working cell bank (WCB). The WCB is critical for scale up manufacturing of therapeutic producing cells and is used for later phases of therapeutic development.
Altogen Labs services include comprehensive environmental monitoring program, as well as MCB production appropriate for cGMP studies. We also offer MCB services for in-market supply production or late phase study.
Master Cell Banking
Therapeutic antibody producing cells are created through the introduction of expression constructs and vectors into the genomes of cell lines from a variety of species. These cell are usually created through gene transfection or transformation, followed by selective screening processes in which the desired expression or inhibition of biological characteristics (proteins, mRNA, etc.) are used to identify potential therapeutic antibody producing 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 to minimize potential contamination and genetic variation that may occur during handling.
Working Cell Banks
WCBs 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 available at Altogen Labs, including:
• Insect Cells
• Mammalian Cells
• Rodent Cells
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.
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
Altogen Labs ships to any destination worldwide
For pricing quote contact us at email@example.com or call Altogen Labs technical support: 512-433-6177