The cost of drug production has put increasing pressure on many biopharmaceutical companies, and everyone has been looking for ways that they can produce high-quality products while saving costs, especially manufacturers that are included in the national drug pool or are quasi-included in the pool, as well as companies that are facing the challenge of biosimilars. Cost savings are likewise an urgent roadblock for some manufacturers of generics, orphan drugs, and personalized and customized medicines.

Recently, Sundise Jichen signed a contract with a biopharmaceutical company for a fully automated perfusion bioreactor project, which includes a 5L glass-type bioreactor with a 0.19m2 tangential flow filtration system and a full set of automatic control system.

I. Key points of perfusion culture: As the perfusion culture process is more and more emphasized by the biopharmaceutical industry, it is very necessary to pay attention to the various key points of the process development. various key points is very necessary.

ii. There are six keys to perfusion culture process development:

(1) Cell interception system

(2) Metabolite control

( (3) Perfusion rate

(4) Medium screening

(5) Aeration efficiency

(6) Batch-to-batch stabilization control & critical quality attributes

3. Advantages of Perfusion Culture

3.1 Maintaining a Constant Culture Environment

(2) Replenishing Fresh Medium to Provide Adequate Nutrient Substrate

(3) Removing Depleted Medium to avoid accumulation of harmful metabolites such as lactic acid

(4) Maintaining constant substrate levels and avoiding large fluctuations in the culture environment, e.g., pH and other conditions

3.2 Increasing yield

(1) Extending the incubation time , increase cell culture density

(2) Increase bioreactor capacity per unit volume, and weaken reactor volume limitations. It can enable small-scale bioreactor production to reach the amount of protein obtained from the mass production of replenishment batch culture, realizing the miniaturization of the culture scale

(3) Improve the utilization rate of the reactor

3.3 Ensure the quality of the product

(1) Reduce the retention time of the product in the reactor to avoid degradation of the product due to factors such as enzymes or temperature

(2) Timely downstream process treatment or disposal of the product to speed up the production process

The use of the perfusion culture process can be used in the biopharmaceutical process to The use of perfusion culture process can effectively reduce the cost and improve the efficiency and productivity in the biopharmaceutical process, so the perfusion culture process is getting more and more attention.

SanDeJiChen has always been concerned about the pharmaceutical industry, with the mission of bringing together the world's leading technology to help China's pharmaceutical development, and is committed to becoming the world's most trusted bioreactor experts and pharmaceutical process partners.