Pharmaceutical Technology-12-02-2017

Regulatory Watch
Pharmaceutical Technology

December 02, 2017

The European Commission’s effort to relax supplementary protection certificates to help generic-drug makers and biosimilars producers has sparked strong opposition from the research-based pharmaceutical sector.

Pharmaceutical Technology
Features

December 02, 2017

Softgel capsules are a popular dosage form among patients but they also provide a number of manufacturing benefits over liquid-filled hardgel capsules.

Modified-release lipid-based formulations in softgel capsules can address physiochemical and pharmacokinetic challenges posed by drug compounds.

Ask the Expert
Pharmaceutical Technology

December 02, 2017

SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Regulatory Watch
Pharmaceutical Technology

December 02, 2017

New gene therapies and combination products require innovative regulatory approaches.

Outsourcing Outlook
Pharmaceutical Technology

December 02, 2017

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

Pharmaceutical Technology

December 02, 2017

In a productive year, 2017 was filled with acquisitions, facility expansions, and new biopharma technology.

Pharmaceutical Technology
Features

December 02, 2017

Optimizing water and HVAC systems can reduce resource use in all pharma facilities, and, for biopharma manufacturing, the supply chain of consumables should be evaluated.

Pharmaceutical Technology

Rinse sample analysis or visual inspection are risk-based approaches that can be correlated to surface cleanliness to replace surface sampling in a biopharmaceutical equipment cleaning process.

Pharmaceutical Technology

Attracting and retaining qualified bio/pharma experts demands a mix of recognition, rewards, and opportunities.

From the Editor
Pharmaceutical Technology

December 02, 2017

Is pharma up to the task of developing knowledgeable, motivated employees?

Pharmaceutical Technology
API Synthesis and Manufacturing

December 02, 2017

For many processes involving hazardous chemistry, running in flow mode has safety and economic advantages.

Pharmaceutical Technology

Amid business and regulatory uncertainty, bio/pharma experts reveal opinions on salary, recognition, and training.

Pharmaceutical Technology

A QbD approach can address manufacturing complexities in transdermal patch manufacturing.

Features
Pharmaceutical Technology

December 02, 2017

Medherant has developed an improved instrument for testing drug release from transdermal patches.

Pharmaceutical Technology

Cross-functional reliability rooms identify risk and planning metrics, provide insights for production forecasts, and predict trends and areas for improvement.

Pharmaceutical Technology
Features

December 02, 2017

A technology roadmap aims to drive and consolidate improvements in a process that has remained unchanged for more than 70 years.

In Part I of this article series, the authors discussed the regression control chart method for identifying out-of-trend data in pharmaceutical stability studies. In Part II, the by-time-point method and the multivariate control chart method are investigated, and improved approaches are suggested. The method is illustrated using real data sets.

Pharmaceutical Technology
Product Spotlight

December 02, 2017

The Hiden ExQ quantitative gas analyzer is a mass spectrometer system providing continuous on-line analysis of dynamic gas streams at pressures from sub-atmospheric up to 30 bar.

Pharmaceutical Technology
Product Spotlight

December 02, 2017

The VERSA Telemanipulator from Central Research Laboratories (CRL), a Destaco company, is suited for remote-handling applications that involve specific customization requirements.

Pharmaceutical Technology
Product Spotlight

December 02, 2017

The Ross, Charles & Son Ross X-Series is a clean-in-place (CIP) ready ultra-high shear mixer for inline emulsification, particle size reduction, and homogenization.

Pharmaceutical Technology
Product Spotlight

December 02, 2017

The InMotion Karl Fischer (KF) Oven Autosampler from Mettler Toledo is suited for KF titration and comes in two models, InMotion Flex and InMotion Pro, and allows up to 26 samples to be analyzed on a 25-centimeter platform.

Issue PDF
Pharmaceutical Technology

December 02, 2017

Click the title above to open the Pharmaceutical Technology December 2017 issue in an interactive PDF format.