CLB's N-1 perfusion manufacturing process

By Travis Pysar, Chief Operating Officer, Cheerland Biotechnology

Cheerland Biotechnology (CLB) has incorporated perfusion technology at the N-1 bioreactor step in both our5,000Land15,000Lfacilities. Perfusion capabilities at the N-1 bioreactor step can be utilized for a perfusion process harvested directly from the N-1 bioreactor or the N-1 perfusion can be utilized for process intensification of the production bioreactor.

Perfusion Processes

The N-1 bioreactor can be utilized as the production bioreactor for a perfusion process or continuous manufacturing process. Perfusion processes rely on smaller bioreactor volumes where the product is harvested on a continual basis and the harvested material is replaced with fresh media. Utilizing the smaller N-1 bioreactor as the perfusion production bioreactor decreased the media required to maintain the cell culture, thereby reducing the media prep vessel size requirements and reducing the cost of the media. Perfusion processes can easily achieve a10 g/Ltiter over a typical 14-day process, thereby increasing the output compared to a standard fed-batch process.

CLB has incorporated a direct transfer from the N-1 bioreactor to facilitate a perfusion process or allow for a smaller production bioreactor size for fed-batch process.

Process Intensification

The N-1 bioreactor can also be utilized to intensify the cell culture density in the seed train prior to inoculating the production bioreactor. Similar to a perfusion process, the media is continually replaced with fresh media to support high cell densities in the N-1 bioreactor. The production bioreactor is then inoculated with a high seed density to promote higher titers in the production bioreactor. This process intensification can yield titers from8-10 g/Lin the production bioreactor.

Flexibility

CLB is committed to meeting the needs of all of our clients, whether that is through a standard fed-batch, an N-1 perfusion batch, a N-1 fed-batch, or an N-1 process intensification. Our state of the art facilities offer the most flexibility and the highest productivity.

关于乐土：

乐土创始团队于2016年初回归祖国，在深圳创立乐土精准医疗科技（简称“乐土”）。2021年入选“新华社民族品牌工程”，致力于成为世界级生物医药龙头企业。由诺贝尔奖得主、"DNA之父"詹姆斯·沃森博士任科学总顾问，投资引进和自主研发并举，打造一个集生物药开发智造（CDMO）、基因检测、医疗和医养基地于一体的精准医疗产业生态，不断追求“健康乐土，健康中国”的使命。乐土在中国深圳、北京、上海、成都等城市设有子公司或医学检验所，在美国（硅谷、纽约）和欧洲（英国）设有投资和商务拓展部门。