The standardized preparation of cell lines is vital to ensure the quality and safety of biological products during commercial production. Creative Biogene provides microbial cell bank generation services, including GMP production or non-production master cell banks (MCB), working cell banks (WCB), end-of-production (EOP) cell banks, and research cell banks. Services are available at research grade, GLP or GMP grades.
Highly efficient expression of recombinant proteins (can reach 2-8g/L), including inclusion body expression, soluble expression, and secretory expression, depending on the properties of the protein of interest.
The core procedures for therapeutic protein/antibodies production are the establishment of a Master Cell Bank (MCB) and a Working Cell Bank (WCB) in full accordance with quality standards. Our facilities have the equipment, expertise, and flexibility to ensure high-quality and speedy cell bank production.
Research Cell Banking (RCB)
Cells that produce therapeutic proteins or antibodies are created through the introduction of expression constructs and vectors into the genomes of microbial cell lines from a variety of species. These cells are typically modified, 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, research 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 to minimize potential contamination and genetic variation that may occur during handling.
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.
End-of-production cell banks are applied to performing fermentation production operations at the biopharmaceutical development program. An EOP bank must be made for each GMP bicrobial fermentation product. Testing of an EOP bank is generally not required for an early-phase product. If the EOP bank is required to be tested (by a regulatory agency, IND sponsor or NCI), the EOP bank will be tested complying with the guidelines.
