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
The LyoCapsule Freeze Dryer is a lyophilization instrument that delivers results comparable to larger R&D freeze dryers enabling a Quality by Design (QbD) approach to cycle development even when materials are highly expensive or limited in quantity.
Extractable and Leachable studies are often straightforward, but they also can be some of the most analytically challenging components of a development program.
Multisorb Technologies provides leadership, innovation, and solutions utilizing active packaging components to manage moisture, oxygen and/or hydrocarbons in healthcare product packaging to improve product stability.
AMETEK Brookfield's Powder Flow Tester delivers quick and easy analysis of powder flow behavior in industrial processing equipment. The PFT is ideal for manufacturers who process powders daily and want to minimize or eliminate the downtime and expense that occur when hoppers/silos fail to discharge.
