Process Development for Recombinant Proteins

Proteins are the workhorse in biological systems facilitating most of the biological processes in a cell. Recombinant proteins have been produced for over 30 years. Recombinant proteins are proteins encoded by recombinant DNA that have been cloned in an expression vector that supports the expression of the gene and translation of messenger RNA. Modification of the gene by recombinant DNA technology can lead to the expression of a mutant protein. On the one hand, recombinant proteins are useful tools for understanding protein-protein interactions; on the other hand, recombinant proteins provide important therapies for a variety of diseases, such as diabetes, cancer, infectious diseases, hemophilia, and anemia.

Creative Bioarray offers cell support services in the process of development for recombinant proteins to help our customers worldwide. We delivered rapid and accurate results to assist customers to accelerate their research.

Our Processing of Recombinant Protein

• Amplification of gene of interest (GOI).
• Insert into a cloning vector.
• Sub-cloning into an expression vector.
• Transformation into the protein-expressing host (bacteria, yeast, mammalian cells, or baculovirus-insect cell system).
• Test for identification of recombinant protein (Western blot or Fluorescence).
• Large-scale production (Large scale fermenter).
• Isolation and purification.

The Role of Cell Banks in Recombinant Proteins Manufacturing

• GOI expression plasmids are inserted into an appropriate host system to establish a recombinant cell/organism which can be frozen for later use. From vials of frozen cell banks, cultures can be established to initiate a production run. Typically, harvests are executed when cultures have achieved high cell density in batch or fed-batch cultures.
• Various host systems can be used to produce recombinant proteins. For more than 20 years, Chinese hamster ovary (CHO) cells remained the preferred mammalian cell line for the production of recombinant protein therapeutic. Our cGMP-compliant CHO cell banking service provides strong support for recombinant protein production.

Fig. 1 Illustration of a typical process to develop a mammalian cell line for recombinant protein manufacturing. (Lai T, et al., 2013)

• The HEK293 cells have been extensively used as an expression tool for recombinant proteins since they were generated. They can generate functional, mature proteins from a wide spectrum of both mammalian and non-mammalian nucleic acids due to their biochemical machinery that is capable of carrying out most of the post-translational folding and possessing. We provide sufficient material supply in the process development for recombinant proteins by our cGMP-compliant HEK293 cell banking service.
• The insect cells are gaining ground rapidly as a platform for recombinant protein production. Insect cells present several comparative advantages to mammalian cells, such as ease of culture, higher tolerance to osmolality and by-product concentration, and higher expression levels. We provide a uniform and intact cell population in the process of development for recombinant proteins through our high-quality insect cell banking service.

As a professional services provider in the field of cell science, Creative Bioarray provides strong cell support in process development for recombinant proteins to our customers worldwide. We provide our clients with direct access to our experts and prompt responses to their questions. If you are interested in our services or have any questions, please feel free to contact us or make an online inquiry.