Pharmaceutical Technology-10-02-2017

Pharmaceutical Technology
API Synthesis and Manufacturing

October 02, 2017

CDMOs have established strategies for handling new chemical entities with unknown biological activity.

From the Editor
Pharmaceutical Technology

October 02, 2017

Reeling from financial and tropical storms, Puerto Rico needs stable industry for recovery.

Cover Story
Pharmaceutical Technology

October 02, 2017

The pharmaceutical industry is under tremendous pressure to make drug development faster and cheaper. Applying the right formulation strategy using structured and rigorous science can help avoid costly failures and re-starts, but it’s important to start from an early stage.

Pharmaceutical Technology

Applying the right formulation strategies early in the drug development process can help avoid costly late-stage failures.

Regulatory Watch
Pharmaceutical Technology

October 02, 2017

The European Commission is striving to tackle environmental pollution by pharmaceuticals as a means of curbing antimicrobial resistance.

Pharmaceutical Technology
Features

October 02, 2017

Choosing between presterilized and bulk sterilized prefilled syringes.

Regulatory Watch
Pharmaceutical Technology

October 02, 2017

Industry and FDA face new fee structures and new challenges in implementing fee initiatives.

Pharmaceutical Technology

Tools aid scale-up and comparison of single-use and stainless-steel bioreactors.

Pharmaceutical Technology
Outsourcing Outlook

October 02, 2017

Mergers and acquisitions are positive for the CDMO industry, but there is a downside.

Ask the Expert
Pharmaceutical Technology

October 02, 2017

Focusing on whether the product meets its defined quality attributes should help one make reasonable, documentable, and defendable risk-based decisions, according to Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Pharmaceutical Technology
Product Spotlight

October 02, 2017

The Thermo Scientific Pharma mini implant line is an integrated solution built around the Thermo Scientific Pharma mini HME twin-screw micro compounder.

Pharmaceutical Technology
Product Spotlight

October 02, 2017

Fluid Air’s PolarDry spray dryers use electrostatic technology, providing low-temperature spray drying, encapsulation, and selective agglomeration in the creation of particles.

Pharmaceutical Technology

Ross, Charles & Son’s VersaMix is a multi-shaft mixer designed for viscous applications requiring a high level of accuracy and batch-to-batch consistency.

Pharmaceutical Technology
Product Spotlight

October 02, 2017

An updated version of Shimadzu’s LabSolutions analytical data system incorporates additional functions to comply with data integrity regulations, and to support development and quality inspection procedures.

Pharmaceutical Technology
Features

October 02, 2017

Capsules offer certain benefits over tablets for oral-solid dosage drugs, and several types of capsules are available.

Pharmaceutical Technology

Manufacturers introduce innovations in glass and plastic packaging for injectables.

Features
Pharmaceutical Technology

October 02, 2017

EMA and FDA guidance encourages design of drug products to improve patient compliance.

Statistical Solutions
Pharmaceutical Technology

October 02, 2017

Is there a difference between a specification and a standard?

Pharmaceutical Technology
Features

October 02, 2017

This article discusses fully automatic inspection of glass and plastic containers and factors that affect particle detection rate. 

Pharmaceutical Technology

This article seeks to promote dialogue among stakeholders to facilitate consensus regarding requirements for excipients.

Pharmaceutical Technology

The authors demonstrate that a proper measure of HPMC solution concentration is its electrical conductivity rather than its viscosity.

Pharmaceutical Technology
Features

October 02, 2017

Just as FDA strengthens ties between reviewers and plant inspectors, proactive manufacturers are involving different disciplines in preparation for FDA audits.

Pharmaceutical Technology

Instead of rigidly applying statistical tools, experts suggest that pharma embrace statistical thinking, but focus on reducing variability and adding value for patients.

Features
Pharmaceutical Technology

October 02, 2017

Lawrence Yu, deputy director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), and his FDA colleague, Michael Kopcha highlight the importance of Six Sigma approaches to continuous improvement in the pharmaceutical industry.

Issue PDF
Pharmaceutical Technology

October 02, 2017

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