Goodwin Biotechnology offers a Single Source Solution™ that starts with cellline development and extends through Process Development and cGMP manufacturing.
We have collaborative partners for molecular biology and cell line development activities with whom we work to develop your cell line. Working with our partners, we can develop cell lines from cDNA or gene sequences that you provide for antibodies, hybridomas, or recombination proteins and to engineer highly productive and stable cell lines in HEK-293, BHK, CHO, NS0, SP2/0 cells or proprietary third-party systems like PER.C6®, ACE, GS, and UCOE.
Our partners offer their own proprietary vectors to develop cell lines that can routinely produce up to 4g/L in CHO cell lines. If you have an existing vector, we can start the cell line development from that. If you do not, we will do gene synthesis where we do vector design and construction.
We adopt a risk-based, Quality by Design (QbD) approach for all projects, and specifically Cell Line Development. Before we start a project, we created a cell line development project plan (Design Input Plan). Our clients review the plan and we only start on the project after it is approved.
Once transfection of the cell has been done, screening amplification and subcloning will be performed, which is then followed by the adaptation of cell lines to suspension culture in media that is serum-free and chemically-defined. If you so desire, we will have a stable pool of transfectants generated and characterized for you before we generate a high-producing single stable clone.
We identify between 3 and 5 high-producing single stable clones and we will create 10 liquid nitrogen vials of each of the clones. There is a shake flask stage of the cell line development process where you can get a small sample of the harvest and purify it for initial protein structural characterization (quaternary, tertiary, secondary, or primary). You can also do binding characteristics through such methods as binding kinetics, mass spectrometry, amino acid analysis, glycosylation, and potency. This, coupled with productivity and generational stability data, helps in the selection of the best cell line for your Research Cell Bank (RCB).
Our team also performs generational stability studies during the cell line developmentprocess. We do this for up to 50 generations. We evaluate such things as cell growth productivity and cell growth kinetics for every five generations. We will produce up to 40 vials of the RCB and we will have it tested for such things as adventitious viruses, mycoplasma, and sterility. We will develop a final cell line development report which you get to review and approve before we ship the product to you.
The final product is then ready for process development work and for GMP MCB creation. Our Process Development team is led by Dr. Legmann who has over 10 years of experience in the production and characterization of clones to fully active mammalian and bacterial recombinant protein expression products. She and her team have vast experience in mammalian cell culture bioreactor optimization which makes it possible for us to develop a robust and reproducible cell culture process for the production of complex therapeutic protein drug candidates.
At Goodwin Biotechnology we also provide expert Regulatory support to our clients to assist them in quickly and effectively moving their drug candidates through the regulatory application and review process. Goodwin Biotechnology provides full regulatory support services for projects beginning with process development initiatives in support of toxicology study materials through the preparation of Chemistry, Manufacturing & Controls (CMC) information for IND filings and amendments. Our staff provides regulatory assistance in all aspects of client projects including meeting with regulatory agencies to discuss manufacturing and testing issues. Our staff is knowledgeable in US, Canadian, and European requirements, as well as guidelines for products produced using novel platforms. Please contact us