Yocell Biotechnology (Qingdao) Co., LTD

In recent years, with the rapid development of the biopharmaceutical industry, antibody drugs have become an important means of treating major diseases such as cancer and autoimmune diseases. In the production process of antibody drugs, purification is one of the key steps, and tangential flow filtration, as an efficient separation technology, plays a crucial role in the formulation of antibody drugs.

Biopharmaceuticals are medicines prepared using biomanufacturing techniques. Compared with traditional medicines, biopharmaceuticals are characterized by being derived from biological products, highly specific, safer and more effective. Currently, biopharmaceuticals are becoming a focal area of development in the pharmaceutical industry, and injectable biologics have accounted for almost 90% of the entire biopharmaceutical market. The main method used in the manufacturing process of biopharmaceuticals is fermentation technology. Fermentation technology utilizes the metabolic capacity of microorganisms for the conversion and production of organic and inorganic substances. The microorganisms used in biopharmaceuticals are cell culture toxin-producing bacteria, protein-expressing bacteria, and cell culture viruses.

Recent advances in recombinant DNA technology have paved the way for the production of recombinant proteins that can be used as therapeutic drugs, vaccines and diagnostic reagents. Recombinant proteins for these applications are mainly produced using prokaryotic and eukaryotic expression host systems (e.g., mammalian cells, bacteria, yeast, insect cells, and transgenic plants) in both laboratory-scale and large-scale environments. The development of efficient bioprocessing strategies is essential for the industrial production of recombinant proteins with therapeutic and prophylactic implications.

Enzyme engineering is a science in which enzymes, enzyme containing organelles or cells (microorganisms, animals, plants) are used in certain reaction devices, using the biocatalytic function of enzymes, and using engineering means to convert corresponding raw materials into useful substances and used in social life. It includes preparation of enzyme preparation, solidification of enzyme, modification and transformation of enzyme and enzyme reactor. Its application is mainly concentrated in the pharmaceutical industry, food industry and light industry.

Filtration is widely used in biopharmaceutical manufacturing processes for the removal of process impurities and contaminants (particles, viruses) as well as the control of bioburden. The role of filtration has evolved as bioprocesses have moved towards intensification and the physical size and biochemical complexity of therapeutic products have increased. Optimising filtration steps to improve yield and product recovery while achieving acceptable process economics is now an increasing challenge. Collaboration between filtration technology suppliers, biopharmaceutical manufacturers and regulatory agencies is facilitating the development and adoption of new solutions to address these challenges.

The use of Single-Use Systems (SUS) in biopharmaceutical manufacturing has changed dramatically over the years. While we have seen a steady increase in the acceptance of SUS over the past few decades, COVID has created an environment that has accelerated the shift away from fixed stainless steel bioprocesses.