An Overview of Our Cell Culture Manufacturing Service

Goodwin Biotechnology offers a full range of mammalian cell culture services ranging from cell line development, with our partners, through the creation of up and downstream processes sufficient for the manufacturing of proof of concept, toxicology product material and processes for licensed cGMP 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.

Cell culture manufacturing operations at Goodwin Biotechnology are managed by SooYoung S. Lee, PhD, Chief Operating Officer, who has several decades of experience in the biotechnology industry. After earning his PhD in Biochemical Engineering at Cornell University, he held several  leadership positions at leading biopharmaceutical companies and CMO’s such as SAIC – Frederick, Schering-Plough Research Institute, Wyeth – Lederle Vaccines, AppTec, Neose Technologies and Genencor. He also has extensive experience in international biotechnology operations, having established and served as the Director of the Biopharmaceutical Manufacturing Technology Center (BMTC) in Singapore, and as a Senior Member, he helped establish the International Vaccine Institute (IVI) in Seoul, Korea.  SooYoung’s team is equally competent. It has vast combined experience in all aspects of cell culture expression systems. As importantly, the team is highly trained in compliance programs and quality systems.

Our cell culture manufacturing clients come from all over the world. They range from universities to research institutes and from biotech startup firms to pharmaceutical companies. Our clients are usually looking for material for everything from pre-clinical and tox studies to late-stage clinical trials.

We understand the need for robust and reproducible cell culture process for the production of complex therapeutic protein drug candidates, and as such, our cell culture manufacturing process is of the highest quality, no matter the complexity of the product being produced. We employ different cell cultivation technologies which range from stationary culture disposable flasks, spinners, WAVE disposable and stirred tank bioreactors. Our variety of bioreactor systems include stirred tank batch/fed-batch bioreactors with capacities of up to 500 liters and with yields of up to 3 grams per liter, Fibracell disk immobilized bed perfusion bioreactors with cartridge surface areas from 2.1m² to 25.2m² and with yields of over 150 grams over 6-week production runs, and 6 X 5L Sartorius Bioreactors for the development of specific run parameters and scaling data for the larger production bioreactors. These small systems are also available for those who want non-GMP material for toxicology studies and testing.

An important part of our manufacturing process is media selection & development (for both animal-free and animal components). We do the media selection with the optimization of your line’s productivity, compliance level, and growth performance in mind.

We also offer support services such as the outsourcing of testing to qualified independent safety testing laboratories, Assay development and characterization, quality control, and quality assurance.

Quality is very important to us and as such, Quality is the intrinsic focus of all management practices that make up these systems. These cell culture manufacturing practices include the following elements: proper planning, performance of appropriate tasks, timely assessment, and continuous improvement of established processes. By addressing these elements in the research, development, operations, and support activities, defined goals are met and both the Goodwin Biotechnology and the client requirements are satisfied. All work is performed with dedication to excellence and with an objective of dynamic and continuous improvement.

We understand that our clients are looking for comprehensive solutions and as such, we do more than cell culture manufacturing. Other related services are bioconjugation (including highly cytotoxic antibody drug conjugates [ADCs]), avian and tobacco plant transgenics, as well as biosimilars and biobetter development.