Selecting the right expression system is crucial to set up your program for long term success. Rapid entry into cGMP production is crucial to make your biologic candidate available to patients.
It is important to understand the different options in expression systems can give you as you move your program from a discovery stage to the pre-clinical stage. Are you using the best expression system for your program? Will it support both Early Phase and Late Phase production? Does it have any licensing fees that must be considered long term?
There are well proven and options available for expressing biologics and vaccine products. In our experience, some of the most common expression systems used in the industry are:
|E. Coli||Manufacturing costs are lower than other systems due to shorter cycle times and lower Cost of Goods (COGs).||Purification process could be complex and costly.|
|CHO||Good glycosylation, well established in the industry for Monoclonal Antibody production.||Longer manufacturing cycle times and higher COGs (i.e., cell culture media/feeds).|
|Pichia/ Saccharomyces||Mid-level COGs. Generally have average to good productivity.||May result in product with unnatural sugar structures and product variants.|
|Baculoviruses expression systems (BEV)||These systems have rapid/easy molecular biology. The product may have sugar structures that may be beneficial for the vaccine applicants.||The productivity can be very low.|
|Hybridomas||Allow for rapid expression.||Their unstable nature is a limitation for routine, robust manufacturing. may have regulatory hurdles.|
As your partner, we help expedite this process by bringing our years of experience, range of capabilities, and our own expression platform technologies expression platform technologies for microbial expression, pAVEway™, and mammalian expression, Apollo™, to your development process. Our expression platforms were designed for efficiency and manufacturability giving our customers one expression system, for life.
Our recombinant protein and sub-unit vaccine expression system experience is further enhanced with our practical knowledge with Viral Vaccines Expression systems. This experience expands beyond CHO and BEVs systems to include HEK, Vero, MDCK and EB 66 Virus Replication Host Platforms. Our Viral Vectors experience includes Adenovirus, Adeno-associated virus (AAV), Lentivirus and Poxvirus.