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 offer cell line development services where we can develop cell lines from cDNA that you provide.
Our Approach to Cell Line Development
Goodwin Biotechnology will work with one of our collaborative partners for molecular biology and the cell line development process. For each project, we will prepare a cell line development project plan (design input) for your review and approval. The typical plan includes:
- Cell line development can either begin with an existing vector you supply, 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 cells or BHK, NS0, HEK-293, SP2/0 cells. We also work with 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.
Generational Stability Studies of Cell Line and RCB Creation
For each project, we will prepare a project plan for your review and approval. The plan includes:
- 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 you, 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 you for each project.
Contact us learn more on our approach to cell line development.