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.
A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.
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