Pharmaceutical Technology-11-02-2016

November 02, 2016

Siegfried Schmitt, PhD, principal consultant, PAREXEL, discusses how to prepare for an inspection by a foreign regulatory agency.

November 02, 2016

The article proposes an integration of method validation, transfer, and verification process into the overall lifecycle management process.

November 02, 2016

This article will clarify reasonable expectations for the responsibilities of topical product formulation developers and for excipient suppliers regarding the information and samples for experiments needed for QbD.

November 02, 2016

Reliable, high-quality products require innovative analytics and production.

November 02, 2016

A lifecycle approach can be used to develop GMP-compliant cleaning procedures for continuous manufacturing of solid-dosage pharmaceuticals.

November 02, 2016

Shear-sensitive ingredients in a tableting formulation experience different conditions in a batch tumble blender than they would in a continuous paddle blender.

November 02, 2016

Sartorius Stedim Biotech’s polyethersulfone membrane is now integrated into two new, sterile Sartocon benchtop and production-scale filtration assemblies.

November 02, 2016

Dual-Shaft Mixers from Ross, Charles & Son are suitable for mixing 50-, 100-, and 200-gallon batches.

November 02, 2016

Yarra 1.8µm SEC-X300 from Phenomenex is a high-resolution gel filtration chromatography (GFC)/aqueous size-exclusion chromatography (SEC) column for the separation of high molecular weight biomolecules on high-performance liquid chromatography and ultra-high pressure liquid chromatography systems.

November 02, 2016

The InvivO2 workstations range from Baker Ruskinn allow researchers to conduct cell culture processes under a continuously controlled, physiologically relevant atmosphere.

November 02, 2016

A dissolution method should have adequate discriminatory power to detect formulation changes that affect the dissolution rate of a drug product.

November 02, 2016

A variety of strategies have been employed to deliver proteins and peptides in improved parenteral formulations and/or via noninvasive routes.

November 02, 2016

The pharmaceutical industry has weathered its share of “black swan” events.

November 02, 2016

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

November 02, 2016

In 2009, the International Pharmaceutical Excipients Council introduced an Excipient Information Package that includes a product requirement datasheet, site quality overview, and site and supply chain security overview.

November 02, 2016

Outcry against high pharmaceutical pricing brings questions of high R&D costs and restrictive payers, but also drug development and manufacturing efficiency.

November 02, 2016

Recent astronomical price increases have driven accusations that some pharma companies are price-gouging.

November 02, 2016

CMO executives are focusing on M&A activity, new business models, and fundraising limits.

November 02, 2016

FDA redefines cocrystals as APIs and not drug-product intermediates.

November 02, 2016

CPhI Pharma Award winners were recognized for sweating the details for the bigger picture.

November 02, 2016

Robust data integrity begins with both management and employees embracing a quality culture and successful implementation of data governance measures.

November 02, 2016

Click the title above to open the Pharmaceutical Technology November 2016 issue in an interactive PDF format.