OSD
New product introduction (NPI) is the process of taking an idea for a novel pharmaceutical product from a working prototype to a refined product ready for clinical trial or even for commercialisation.
It’s the basis and foundation of successful product development or product transfer for any commercial or clinical supply project.
The risks of poor NPI pharma
Whether a pharmaceutical company is launching a completely new product, or reformulating an existing therapy, introducing new processes into operations can be challenging if it’s not planned properly.
Moreover, failure to plan increases the risk of quality issues arising as operators scale up new production processes. Equipment available at the pilot stage might not be compatible with the infrastructure needed for clinical or even commercial manufacturing. It can be costly and time-consuming to address this problem to enable the project to progress.
Good NPI is designed to ensure that there is a comprehensive and effective plan in place at the start of a product’s development journey to minimise these risks.
Unlocking the secrets to effective NPI
A number of measures are vital to ensuring NPI is planned and executed appropriately:
-
Communication between each and every team as the project progress from discovery to pilot to product
-
Comprehensive tech transfer support to hand over all knowledge and expertise at every stage of the product’s development journey
-
Structured project management process applied with rigour and discipline
-
A scientific approach to product development along Design of Experiments (DoE) principles to assess and address risk and identify critical parameters.
Expert support is key
Contract development manufacturing organisations (CDMOs) with experience in NPI are well placed to support companies NPI.
With the right assistance, companies can be confident that the right processes are in place to prevent quality issues from occurring, and to eliminate risks that can cause delays. They can also be assured that any production processes are designed from the beginning to be easily scalable as the product’s manufacturing needs evolve, smoothing their project’s journey from discovery to commercialisation.
In a recent interview with Life Sciences Knowledge Hub, Dr.Uwe Hanenberg, Head of New product Implementation at Recipharm, explored the risks and challenges pharmaceutical companies face when undertaking NPI. He also explained how CDMOs can support companies in overcoming NPI issues to deliver their innovations to market successfully.