Pharmaceutical Technology, July 2023

To overcome the challenges of the widening range and scope of products that require aseptic processing and the evolving regulatory landscape in this field, companies should deepen their knowledge base on best practices.

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

Sample dilution, sensitivity, excipient interference, and containment are key issues that must be addressed.

Manufacturers face the challenge of meeting growing demand for personalized biopharmaceuticals.

Data from environmental monitoring can assist in keeping sterile environments sterile.

Automation can be balanced with operator oversight.

Detection of nitrosamines in several commercial drugs has resulted in manufacturing batch recalls followed by a review of the APIs’ synthesis processes by MAHs.

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

Problems continue despite actions by regulators to better prevent and address drug shortages.

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

If we view a change opposite of one’s interest as antithetical to innovation, we risk losing sight of our ultimate goal.

The debate surrounding drug pricing changes rages on.

Ross Engineering custom fabricates tanks, pressure vessels, and reactors for various manufacturing and storage functions.

Bruker Corporations timsTOF Ultra mass spectrometer features a captive spray ionization ino sources that provides optimized vortex gas flow.

TurboFil Packaging Machines Mini-Monoblock MDN-50 is designed to accurately and expediently fill, seal, cap, and label spray multi-dose nasal dispensers.

Beckman Coulter Life Sciences’ Light Array Module enables high-throughput screening and process optimization for various phototrophic organisms.

A novel complement therapeutic CTx001 offers a novel approach to treating geographic atrophy.