Cell Line Development in CHO, BHK, NS0, HEK-293, SP2/0

Cell Line Development

Goodwin Biotechnology scientists have considerable experience in the development of cell lines for cGMP manufacturing for clinical studies through commercial manufacturing. In addition, working with our partners, we can develop cell lines from cDNA that you provide. Our partners offer their own proprietary vectors to develop cell lines that can routinely produce up to 4g/L in CHO cell lines.

For more information on our Cell Line Development services please fill out the form below.

Our Approach to Cell Line Development

Goodwin Biotechnology will work with one of our collaborative partners for molecular biology and cell line development activities.
For each project, we will prepare a cell line development project plan (design input) for review and approval by the client.
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, we 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, screening amplification and subcloning will be performed. Cell lines will be adapted to suspension culture in serum-free, chemically-defined media. Also, note that per client request, stable pool of transfectants can be generated and characterized prior to the generation of a high producing single stable clone.
Typically, cell line development activities will result in the identification of three (3) to five (5) high-producing candidate clones and ten (10) liquid nitrogen vials of each of three (3) to five (5) clones will be created.
During cell line development at the shake flask stage, a small-scale, one (1) column protein A purification of the harvest can be performed for each cell line for initial characterization of the protein structural (primary, secondary, tertiary and quaternary) and binding characteristics via methods such as mass spectrometry, binding kinetics (ForteBio Blitz or Octet systems), glycosylation, potency, amino acid analysis, etc., to better aid in selection of the optimal cell line along with subsequent generational stability and productivity data.

To learn more on our approach to cell line development, please complete the form above.

Generational Stability Studies of Cell Line and RCB Creation

For each project, we will prepare a project plan for review and approval by the client.
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 our client we will evaluate the data and choose the best performing clone for creation of Research Cell Bank (RCB).
At least forty (40) vials of the RCB will be produced.
The RCB will be tested for mycoplasma, sterility, and adventitious viruses, and then shipped to Goodwin Biotechnology for process development work and creation of a GMP MCB.
A final report for cell line development will be prepared for review and approval by the client for each project.

To learn more on our approach to cell line development, please complete the form above.

Cell Culture Links