Pharmaceutical Technology-09-02-2015

September 02, 2015

Creating closed processes and reducing room air classification in a biopharmaceutical facility can reduce operational costs.

September 02, 2015

Operator attention to detail and adherence to procedures are crucial for proper cleaning.

September 02, 2015

Current guidance for absorption of elemental impurities does not address dermal exposure, resulting in a simplistic approach to limit setting.

September 02, 2015

Matt Shaffer, manager, formulation development, Bend Research, a division of Capsugel’s Dosage Form Solutions business, and Martin Koeberle, PhD, head of analytical development and stability testing, Hermes Pharma, spoke to Pharmaceutical Technology about the different approaches used in taste-masking and the challenges involved.

September 02, 2015

Suppliers indicate prices for single-use equipment are likely to increase.

September 02, 2015

Legislation to streamline drug development may get tangled up in user fee negotiations and drug pricing battles.

September 02, 2015

The industry is moving towards more flexible manufacturing with the use of modular facilities and single-use systems.

September 02, 2015

Siegfried Schmitt, principal consultant, PAREXEL, discusses how to assure compliance for automated systems.

September 02, 2015

EU and US regulators are striving to work together on improving GMP inspection efficiencies and avoiding duplication of efforts.

September 02, 2015

More complex drug candidates require more specialized and selective chemistry.

September 02, 2015

Industry Expert Q&A with Robin M. Silva, Partner, Morgan, Lewis, and Bockius LLP

September 02, 2015

Adents’ Pharma Suite serialization software features track-and-trace capabilities.

September 02, 2015

Kason’s Vibro-Bed fluid-bed agglomerator is equipped with imbalanced-weight gyratory motors and mounted on a spring suspension.

September 02, 2015

Meissner’s FlexGro single-use biocontainer assemblies feature the TepoFlex polyethylene (PE) multi-layer film and are delivered presterilized for immediate use.

September 02, 2015

Ross’ Three Roll Mill features hardened carbon-steel 52100 precision ground rolls, each cored for water cooling and heating.

September 02, 2015

Ensuring data integrity involves effort on an individual and global basis.

September 02, 2015

FDA’s proposed guidance for quality metrics raises questions about quantifying the tangibles and intangibles of quality culture.

September 02, 2015

QbD is improving the safety of solid-dosage drug products as well improving manufacturing processes, despite some industry reluctance.

September 02, 2015

Click the title above to open the Pharmaceutical Technology September 2015 issue in an interactive PDF format.