Pharmaceutical Technology, June 2022

Industry experts discuss the need for stricter environmental controls, whether to incorporate single-use technologies, and areas for improved automation.

This article describes the in-vitro permeation test study data processing procedures and FDA statistical mathematics of evaluating a generic topical drug product, acyclovir cream, against its reference product.

Putting the patient at the forefront of drug development is essential, particularly to ensure medication compliance is optimized.

The right processes used with the right excipient combinations address evolving formulation needs.

Collecting relevant data, planning ahead, and communicating with regulatory bodies in pre-IND meeting programs can help companies to avoid roadblocks in IND applications.

Analyzing elemental impurities in drug products is—much like other analytical testing—primarily aimed at ensuring patient safety.

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

This article explores the concerns with cleaning pharmaceutical products utilizing LNP delivery vehicles and provides a general cleaning recommendation based on laboratory and field testing.

The inaugural Connect in Pharma event will take place on 14 and 15 September in Geneva, Switzerland.

EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.

Cases of monkeypox are rising around the world, but it is unlikely the virus will become a pandemic problem.

FDA will use virtual site visits even after resuming active inspections.

Is AI a panacea for pharma’s productivity gap?

Precompetitive consortiums seek solutions to industry-wide challenges.

Lions and tigers and monkeypox, oh my!

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, discusses the basics for maintaining an acceptable working relationship between a client and their CDMO.

ROSS reconditioned DPM-40 Double Planetary Mixers offer comparable production to new mixers at a lower cost.

Standard BioTools’ Hyperion+ Imaging System can process more samples and has lower limits of detection than its predecessor.

Colorcon’s OptiClenz delivers cGMP-validated high-performance coating equipment cleaning.

AMETEK Haydon Kerk Pittman’s 57mm size motor in its IDEA Motor series is designed for real-time, embedded motion control.

AI could provide solutions to critical manufacturing inefficiencies.