One of the biggest decisions which any company developing biological medicines makes is to move forward to the manufacture of their product.
This can be one of the most costly and complex decisions you take, and it is vital to get this right. What technology should you use, who should you partner with, how long will it take?
The first point in the journey to your first clinical batch is the creation of a cell line expressing your product. This cell line will be used to manufacture all the product you will need to support in–vivo demonstration of biological activity, demonstrate safety, set a pharmacological dose, and ultimately treat all your patients. This cell line will likely remain through the whole lifetime of your product, remaining unchanged through clinical trials and onto the market.
However, cell line development is a very specialised and complex activity and it can be difficult to navigate the huge variety of choices available. Your choice of cell line and expression platform will influence the efficacy and safety of your product, the cost of goods and the ease of manufacture.