Pharmaceutical Technology, August 2022

The nitrosamines contamination in “sartan” drugs emphasized the importance of risk assessment in the manufacture of active pharmaceutical ingredients.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Industry is adapting to the increasing complexity and poor solubility and bioavailability of molecules in the pipeline.

The purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.

Further advances in construct design and manufacturing scalability are still needed.

This article provides an overview of solutions to address key challenges facing vaccine developers or CDMOs wishing to build their own commercial-scale mRNA production facilities.

The option of using prefilled syringes for vaccinations is not (yet) available for all types of vaccines. Stakeholders are working to expand that option while also pursuing other non-traditional routes of administration.

Automated finished product inspection has been widely adopted in the bio/pharmaceutical industry.

Successful digital transformation in biopharma requires an integrated approach to the data lifecycle.

Screening for apparent total nitrosamine content with a thermal energy analyzer offers a rapid way of identifying contaminated drug products.

Automation of pharmaceutical packaging saves costs and time, say contract packagers.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Promising applications for targeted delivery may be cresting the horizon.

Pharma’s leveraging real-world evidence to drive product approval, reimbursement, and market access.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

The ROSS PDDM Planetary Dual Disperser offers flexibility in the form of removable disperser shafts.

PerkinElmer’s GC 2400 Platform is designed to perform various sampling tasks related to gas chromatography and headspace sampling.

Telstar’s Smart Format system automatically transports vials of different formats.

The Dynatrol G Series Level Switches are designed to accurately measure light or heavier bulk solids for problem applications.

GSK has completed its demerger of Haleon and has signed an agreement to help support future pandemic preparedness in Europe.

How can we fix the quality manufacturing issues that come with product shortages?