Goodwin Biotechnology offers a full range of mammalian cell culture services ranging from the creation of up and downstream processes sufficient for the manufacturing of proof of concept, toxicology product material and processes for licensed manufacturing.
We work with most cell lines used for manufacturing, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and all selection systems used with these lines. We also work with several different selection systems such as dhfr – /methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Our experience includes surface dependent as well as suspension culture types.
Our clients are global and include biotech startup firms, research institutes, universities, multinational biotechnology and pharmaceutical companies, and government institutes with projects from translational medicine to producing materials for clinical trials.
Goodwin Biotechnology will develop a robust and reproducible cell culture process for the production of complex therapeutic protein drug candidates. Goodwin Biotechnology has experience with a number of cell cultivation technologies including stationary culture disposable flasks, spinners, WAVE disposable and stirred tank bioreactors. Goodwin Biotechnology offers cell culture production services for non-bioreactor projects.
- Media selection and development (both animal component and animal-free components)… Goodwin Biotechnology offers medium evaluation and adaptation to commercial serum free formulations for your cell line. Our goal is to increase your line’s productivity, growth performance, and/or compliance level.
- Development and optimization of robust and scalable processes… Goodwin Biotechnology offers three different types of bioreactor systems for production and process development services for each. We work with clients to determine the optimum bioreactor type to use for their project based on their cell expression system and product quantities needed.
- Stirred tank batch or fed-batch bioreactor… Stirred tank bioreactors up to 500L are available. With the possibility of achieving yields up to three grams per liter, our bioreactors could produce up to 1,500 grams per every 8 to 10 day run.
- Fibracell disk immobilized bed perfusion bioreactors…
Bioreactors with cartridge surface areas ranging from 2.1 to 25.2m² are available. The larger of these bioreactors can produce in excess of 150 grams during a six-week production run.
- Hollow fiber
- 6 X 5L Sartorius Bioreactors… Goodwin Biotechnology has available small bioreactor systems of each type for the development of specific run parameters and scaling data for the larger production bioreactors. These small systems are also available for the production of non-GMP material for testing and toxicology studies.
Goodwin Biotechnology manufactures cGMP material for clients using:
- Dakota stirred tanks, 200L and 500L.
- 50L disposable WAVE bioreactor
The scale of bioreactor selected depends on the productivity of the cell line and the requirement for GMP material. Once the GMP material is produced, Goodwin Biotechnology performs in-process and release testing as well as QA review of the GMP manufacturing documentation. In addition, Goodwin Biotechnology offers stability studies, viral clearance studies, creation of a reference standard, etc. to meet regulatory compliance needs.Please contact us.