How are biological medicines manufactured?
Manufacturing biological medicines is generally more complex than the production of traditional (chemical) pharmaceuticals. There are a number of reasons for this, including the nature of the starting material and the very high level of precision required in the manufacturing process.
The starting material for most biological medicines is a genetically modified cell line. Each biotech company uses unique cell lines and develops its own proprietary (unique) manufacturing processes to produce biological medicines.
The unique starting material and the complex manufacturing processes mean that it is not possible to exactly reproduce a biological in the same way a pharmaceutical (chemical) generic can be produced.