Pharmaceutical Technology-04-02-2021

Intensified and distributed manufacturing approaches create flexible, local capacity.

Manufacturers in Europe and the United States have announced plans for new in-country API development and manufacturing capabilities.

This article describes in detail how simulation was used to compare the statistical techniques used to determine out-of-trend (OOT), which is crucial to avoiding out-of-specification (OOS) events for drug substances and products.

Topical drugs are attractive to patients, but these complex products pose challenges for formulators.

Accelerated formulation strategies are a useful tool to reduce development timelines and cost, but key priorities must be considered early on to ensure success.

Although vials and prefilled syringes have different advantages, both find use in vaccine fill/finish.

Decontamination, automation, and containment are important considerations for aseptic manufacturing in isolators.

A well-chosen replication strategy can effectively reduce the uncertainty for an analytical method, enabling appropriate decisions regarding pharmaceutical quality.

After Brexit there is an increased risk of the UK being exposed to counterfeit medicines, but regulations implementing blockchain as infrastructure technology could be the answer.

Despite its importance in drug development, dissolution testing still has some limitations, but advances in automation and real-time monitoring are producing promising results.

The availability of materials is a critical factor when it comes to vaccine capacity.

Concerns over vulnerability in the supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.

Smart, accurate, science-based messaging is needed to advance bio/pharma science.

COVID-19 has placed bio/pharma in the spotlight of global media, but away from vaccines there are other prospective pipeline treatments that will be worth watching.

Experts Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, Inc., and Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, Inc., provide simple answers to frequently asked questions regarding deviation investigations.

High Purity New England launched the VerderFlex Vantage 5000 peristaltic pump for medium flow at low to medium pressures in biopharmaceutical applications.

Triple Shaft Mixers from ROSS are designed to adapt to various viscous applications requiring hygienic and sanitary handling.

HERMA US announced it now includes continuous labeling capabilities for its 132M HC Wrap-around Labeler.

SICK introduced the SICK W4F line of miniature smart sensors designed to reach next-generation detection performance while including new optical technologies to solve typical pharmaceutical sensing challenges.