Pharmaceutical Technology-05-02-2016

Pharmaceutical Technology

The author addresses critical issues to consider prior to performing forced degradation studies and provides best practice recommendations for these types of studies.

Pharmaceutical Technology

Safe handling of HPAPIs requires determining exposure potential and selecting appro-priate containment strategies.

Pharmaceutical Technology

Experts discuss some of the emerging trends in bioprocessing in 2016, including 4D bioprinting, 2D-NMR, and the CAR-T design space.

Pharmaceutical Technology
Outsourcing Outlook

May 02, 2016

Growth may be slowing, but outsourcing activity remains healthy.

Pharmaceutical Technology

As the pharmaceutical industry moves toward continuous manufacturing, new documents are needed to provide flexible guidance that meets the new process requirements.

Ask the Expert
Pharmaceutical Technology

May 02, 2016

Siegfried Schmitt, Principal Consultant, PAREXEL International, discusses how to report quality metrics to FDA.

Inside Standards
Pharmaceutical Technology

May 02, 2016

Revisions and updates for the 9th Edition of the European Pharmacopoeia result in changes to more than half of the content.

Pharmaceutical Technology

Bioprocess operations-from cell line selection to final filtration-can influence the consistency and purity of biologic drug substances.

Pharmaceutical Technology
Guest Editorial

May 02, 2016

Policies for patient access to life-saving therapies must keep pace with biomedical innovation.

Troubleshooting and collaboration are essential in implementing commercial lyophilization processes.

Pharmaceutical Technology

Application for Sirdupla Uniformity of Delivered Dose Methodology

Pharmaceutical Technology
Supply Chain

May 02, 2016

With deadlines only a few years away, some companies have not started serialization programs, while others are taking a tactical, short-term approach, losing out on potential business benefits.

Formulation
Pharmaceutical Technology

May 02, 2016

Armin Gerhardt, associate professor of Pharmaceutical Science, Concordia University Wisconsin School of Pharmacy, discusses the effects of moisture on product quality and how to achieve good control of moisture during pharmaceutical manufacturing operations.

Pharmaceutical Technology
Product Spotlight

May 02, 2016

The penetrometer PNR 12 from Anton Paar, used for quality monitoring, features the Pharma Qualification Package--Smart PNR 12, which fulfills GMP and United States Pharmacopeia (USP) regulations and can be used to perform qualification processes.

Pharmaceutical Technology
Product Spotlight

May 02, 2016

The NEMA 4X Operator Stations, from Ross, Charles & Son, include a 15-inch color touchscreen with Ethernet communications and emergency stop button with hermetically sealed contact block.

Pharmaceutical Technology

The FlexPro 50, from Groninger, is a modular filling and closing system designed to process vials, cartridges, and syringes, as well as vials in bulk and trays.

Pharmaceutical Technology

The Optima AUC from Beckman Coulter Life Sciences is an ultracentrifuge that determines molecular weight, size shape, and polydispersity.

Regulatory Watch
Pharmaceutical Technology

May 02, 2016

In a move to encourage drug development, EU regulators are offering scientific advice to companies on major efficacy, safety, and quality issues at an early stage.

Issue PDF
Pharmaceutical Technology

May 02, 2016

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

Regulatory Watch
Pharmaceutical Technology

April 07, 2016

The campaign against opioid abuse opens door to more innovative therapies.