Quality by Design (QbD) is a systematic approach to product development that begins with predefined objectives and emphasizes product and process understanding and controls based on sound science and quality risk management (ICH Q8). The emphasis of QbD began with the recognition that increased testing does not essentially improve product quality; however, quality must be built into the product.
The importance of optimizing the chemical synthesis and formulation processes in complex molecule development.
To take advantage of the growing HPAPI market, a company must have the proper controls in place to safely handle these potent compounds and successfully bring its drug to market.
In addition to having the optimal cell line and process, it is crucial to have the optimal cell culture medium and feed to maximize performance potential.
As drug developers face the ever-pressing need to get molecules to market as efficiently as possible, firms large and small are increasingly turning to CDMOs for help. At a CPhI North America panel on single-source CDMOs, four industry experts discussed how working with a single-source CDMO partner can accelerate time to market, add cost savings, and improve a formulation’s chances of achieving regulatory success.
One solution to drug development challenges is adopting a parallel operations business model. This article provides several recommendations for how parallel operations can be leveraged in your biomanufacturing strategy.
Manufacturing biologicals is tricky. A major concern is the risk of microbial contamination, jeopardizing product safety and causing high costs. But there are solutions for decreasing the risks.
Currently, there is a transformation taking place that will pave the way for even more changes to how the industry approaches drug manufacturing.
Biotech firms often have tight timelines to prove the concept of their NCE. As a result, modern clinical development pathway requires rapid manufacturing of the “first Kilo”.
Formulation techniques and technologies can become more habit than science, but a single technology does not work for all compounds. Each new drug is unique and deserves a fresh approach to formulation.
|
|
|
|
|
|
|
|
|