Biopharmaceutical Development & Processing
This In-Depth Focus looks at QbD and PAT for cutting biopharma attrition rates as well as continuous freeze-drying technology for biopharma products.
- The importance of critical quality attributes in Quality by Design for rapid bioprocess development strategies
QbD and PAT could revolutionise the way biopharma industries operate by cutting down their attrition rates, which could drastically change their business model. Arathi Kizhedath and Jarka Glassey consider the issues involved.
- A continuous and controlled pharmaceutical freeze-drying technology for unit doses
Among the list of over 300 FDA and EMA approved biopharmaceutical products, around 50% are freeze-dried – indicating that this is the preferred way of stabilising biopharmaceutical drug products that are unstable in aqueous solution, despite the high cost and long processing time linked to this manufacturing technique. Pieter-Jan Van Bockstal, Thomas De Beer and Jos Corver present a continuous and controlled pharmaceutical freeze-drying technology for unit doses.