An Overview of the General Cell Culture Work at Goodwin Biotechnology

Goodwin Biotechnology is a leading biological Contract Manufacturing Organization (CMO) that 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. 

Goodwin Biotechnology works with most mammalian cell lines used for manufacturing, including CHO, NS/0, BHK, 293 as well as murine hybridomas, and all selection systems used with these lines. They also work with several different selection systems such as dhfr - /methotrexate CHO, mycophenolic acid/xanthine, and G418 systems. Their experience includes surface dependent as well as suspension culture types.

Goodwin’s 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

Cell Line Development

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

Cell Banking

Goodwin Biotechnology offers a full array cell banking services for research or manufacturing use. Manufacturing banks include seed, master, working, and post production. All of these banks are GMP compliant and are tested based on the current Points to Consider for cell bank testing. Goodwin Biotechnology works closely with their clients and with our qualified contract testing organizations to assure acceptability of all testing. Banks are prepared using a controlled freeze rate system and are stored in -150°C mechanical freezer systems. All bank inventories are secured and controlled by Goodwin Biotechnology’s Quality department. Short- or long-term storage of cell banks is provided.

·         Research Cell Banks can be made at Goodwin Biotechnology to carry out non-GMP process development activities.

·         Goodwin Biotechnology produces Master Cell Banks (MCBs) and Working Cell Banks (WCBs) in compliance with cGMP requirements.

Cell Culture Process Development

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. Goodwin’s 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. Goodwin works 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, Goodwin’s bioreactors 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.

Cell Culture Process Development

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, WAVEdisposable 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. Their 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. Goodwin works with clients to determine the optimum bioreactor type to use for their project based on the 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, Goodwin’s bioreactors 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.