MCBs and WCBs

The development processes are very critical for biological materials production. The quality of final product based on manufacturing process of cell production; thus, a great care is our major concern while developing the master cell banks. Therefore, proper and characterized cell lines to avoid cell line contamination and genetic variation are our major concern. Our experience processes, and development services we offer address all these issues.

The concept of a two-tiered cell bank is followed in our facility. This involves the use of MCB which is used to generate WCB. WCB is generally accepted as the most practical approach to providing a supply of cell substrate for continued manufacture of the product. Our facility will describe the strategy used to:

• Avoid microbial contamination and cross-contamination by other cell types present in the laboratory
• Provide a continued supply of cells from the GMP grade cell bank(s), including the anticipated utilization rate of the cell bank(s) for production, the expected intervals between generation of new cell bank(s), and the criteria for qualification of cell bank(s).
• Cell banking procedures
• Provide for protection from catastrophic events that could render the cell bank unusable

Preventive measures to avoid contamination
It is important to prevent a contaminated cell bank from being used in production and to avoid a loss of product availability or development time resulting from the need to recreate a cell bank found to be unusable due to contamination. It is recognized that no cell bank testing regimen is able to detect all potential contaminants; therefore, use of these preventive principles during cell banking is important to provide reasonable assurance of the absence of contamination and to provide a reliable source of the cell substrate