Pharmaceutical Technology-07-02-2019

Cultural and language discrepancies during an audit can be resolved using what many call a “playbook,” says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Gericke USA’s RotaVal line of rotary valves discharge powders from hoppers, fill process machinery, dose from silos, and isolate pneumatic conveying zones between sifters, mixers, screw conveyors, and other equipment.

The Planetary Dual Disperser is the newest addition to the Ross planetary mixing line of industrial mixers.

The Masterflex L/S Easy-Load pump head from Cole-Parmer has an updated design and enhanced features for greater ease of use.

New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.

Tecan’s Spark Cyto cell plate reader offers real-time detection and analysis of biological, chemical, and physical events while consistently capturing the maximum amount of data from every well.

Today’s inspection systems catch tinier flaws, manage data, and increasingly rely on artificial intelligence to further boost performance.

Sterile filtration is often required for biologics but presents degradation and compatibility challenges.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

The increasing growth in the cell- and gene-therapy markets is inspiring CDMOs to expand their services in this emerging biologic drug arena.

FDA and USP take sides in debate on biologic drug standards.

Will EMA’s draft guideline clarify questions about the assessment of drug device combinations in relation to the EU medical devices regulation?

This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.

The Wellcome Global Monitor has demonstrated an overall positive trust in science but some concerns still remain on attitudes on vaccines.

Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards.

Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety today?

Automation promises to connect biomanufacturing processes more closely, and to bring greater efficiency to the manufacturing floor.

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