Understand the Cell Line Development Process

Cell line development is important in the manufacturing of high quality recombinant proteins. Goodwin Biotechnology has extensive experience in this field. In conjunction with its collaborative partners, Goodwin Biotechnology can develop a variety of high expressing cell lines from cDNA provided by the client
that can routinely produce up to 4g/L


In order to develop a cell line successfully, a project plan must be prepared which includes all cell line development activities. This plan will be presented to the client for review and approval before initiating the work. There are various ways in which cell lines can be developed.

Cell line development can either begin with an existing vector, as supplied by the client, or vector design and construction (gene synthesis) can be performed. Through our collaborative partnerships, Goodwin Biotechnology can take your gene sequence or cDNA for your recombinant protein, antibody, or hybridoma and engineer a highly productive, stable cell line in CHO, BHK, NS0, HEK-293, SP2/0 cells or proprietary third-party systems (GS, ACE, UCOE, PER.C6®, etc.).


After transfection of the cells, the other two important processes in cell line development are screening amplification and sub cloning. The cell lines will then be developed in serum-free and chemically defined suspension conditions. The client can also opt for a stable pool of transfectants to be generated during cell line development process.
   

The goal for this process is to generate 3 to 5 high-producing candidate clones and ten (10) liquid nitrogenes vials of each of three (3) to five (5) clones will be created.. The stability of the three (3) to five (5) candidate cell lines will be evaluated in shake flask culture for up to fifty (50) generations, for example. Cell growth kinetics and productivity will be evaluated at regular intervals, e.g., every five (5) generations. Together with the client, Goodwin Biotechnology will evaluate the data and choose the best performing clone for creation of the Research Cell Bank (RCB).

Once the RCB is selected, it is going to be tested for mycloplasma, sterility and adventitious viruses, and then shipped to Goodwin Biotechnology for process development work and creation of a GMP Master Cell Bank Once this is done, the reliable biotechnology scientists at Goodwin Biotechnology  will give you a detailed report of the cell development process.

The cell line development process should be tailored to suit customers wishes. You need to find a company like Goodwin Biotechnology that is experienced and very flexible in terms of designing cell line development programs. Look for a company with qualified biotechnologists with many years of experience in the industry and a validated cGMP manufacturing facility.