Reduced Time-to-Market: Vaccine Development

Cell Banks: an Often Neglected Issue

In many companies, product development is very much focused on the generation of the products, and little consideration is given to the production cell banks. In many cases, companies on the verge of GMP production of their research vaccine for clinical trials, encounter the problem that a well-documented and qualified cell bank is needed. Although establishement of a GMP cell bank system is simple in theory, in practice this is a lengthy and expensive process that will bind significant resources and will take quite some time. This is not only due to the time needed for GMP production, but also related to the requirement for extensive quality testing. E.g., on average full testing of a cell bank takes 6-10 months.

Save Time and Avoid Production of Your Own Cell Bank

Production of your own cell banks for manufacturing seems to be an easy task. However, in your vaccine development, you will inevitably be confronted with many issues, from licensing agreements to timing of production slots at a GMP manufacturer. Also, production provides a number of opportunities for mistakes (e.g., size of the cell banks, passage levels, missing data about end of production cells) that are important for entering clinical trials, but might also significantly decrease the value of your further product development. Cell banks are also integral parts of product development in the eyes of the regulatory authorities or potential partners involved in due diligence activities.

Nuvonis GMP Cell Banks Are Ready to Use

By using Nuvonis GMP cell banks for vaccine development, you can immediately jump into GMP production of your vaccine. Your production process is based on a fully tested platform that is state of the art. In addition, the size of our cell banks allows you to get complete independence for manufacturing of clinical grade material and commercial product.

Speed Is Your Benefit

To speed up vaccine development, it is important to avoid timelines and risks associated with the production of your own cell banks. Focus on the item that generates your company value – immediately move into GMP production of your product and do not lose time for cell banking and related quality as well as the regulatory burden.

Source of Cells

Usual sources of cells for cell banking are cell culture collection organisations or suppliers that require milestone dependent and royalty bearing licensing contracts. For your vaccine development, Nuvonis offers an easy and attractive contract.

Step 1

Evaluation of Virus Growth

After a standard Confidential Disclosure Agreement (CDA) and Material Transfer Agreement (MTA)., You can get immediate access to a Working Cell Bank ampoules for evaluation of growth of your virus. We provide media conditions and protocols, so within a few weeks you can verify that your viruses are growing nicely in Nuvonis Vero and avian cells to begin with vaccine development

Step 1

Step 2

The Usual Way: CMO Production

Usually, you would now find, select, audit and negotiate with a CMO for cell bank production. After conclusion of your contract, your timelines are dependent on the availability of production slots for cell bank manufacturing

Step 2

Step 3

The Usual Way: Cell Bank Testing

As part of vaccine development and after the cell banks (Working Cell Bank, Master Cell Bank, End of Production Cell Bank) were produced successfully, you will contract a number of tests according to ICH guidelines, including fPERT, 16-week tumorigenicity in nude mice of end of passage cells. Only after completion of all these tests and after release of the cell bank by a qualified person, can you start to produce your own vaccine/vector product under GMP. In essence, you need to produce three cell banks covering the Master Cell Bank (MCB), Working Cell Bank (WCB) and End of Production (EPCB) passage level.

Step 3

Step 4

The Nuvonis Way

Skip steps 1, 2 and 3 indicated above and rely on our already produced and ready-to-use GMP banks that are fully tested and state-of-the-art. To start with vaccine development, you can immediately move into GMP production of your vaccine or vector and save significant time and money. At the same time, we can ensure that the cell banks provided to you meet the highest quality and regulatory standards.