Materials science is now helping pharmaceutical companies to standardize and control areas such as drug form and manufacture to deliver new products more quickly and with greater quality.
The reality is that several manufacturability problems could be brewing that will rain down during Phase III and cause costly delays, no matter how skilled the product and process may be.
Real-time release testing can be defined as a set of in-process controls that may provide greater assurance of product quality than end-product testing.
QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.
Competition in the generics market has never been greater. At a time when many of the most successful drugs are reaching the patent cliff, opening the floodgates for generic substitutes, generic companies are rushing to target the best candidates and enter the market first.
Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. By Lisa Z Crandall