Pharmaceutical Technology, December 2021 Issue

Bio/pharmaceutical manufacturing harnesses the benefits of digital transformation.

Polpharma implemented digital technologies, including a digital twin of operations.

The authors introduce the idea of asymmetrical tolerance intervals as an aid in fully assessing product performance relative to product or process requirements.

Increased patient-centricity and alternative dosage forms require careful consideration when selecting the best taste-masking approach.

Polymeric amorphous solid dispersions are the most commonly used technology, but amorphous APIs remain inherently unstable.

Isolators move into smaller-volume processes, including cell and gene therapy manufacturing.

Simple, inexpensive real-time analytics are urgently needed for high value products.

While supply chain disruptions have resulted in many alterations to workplace practices, they have also presented an opportunity to get ahead of changes to the EU’s upcoming revision of Annex 1.

Particle analysis is a critical component of pharmaceutical development, providing assurances of the quality and performance of the final dosage form.

Lean delivery offers a promising solution to supply and manufacturing bottlenecks by integrating project teams early on and widening the team’s field of view.

Partnerships formed during the COVID-19 pandemic have provided a platform for change in assay development and transfers that should continue in the future.

Pharma and biotech are ruling the roost in terms of university innovation, but European spinouts are still experiencing barriers to long-term success.

The need for medicines to combat COVID-19 has impacted the way regulatory agencies carry out their operations.

We have broken rules, invented new ones, and engineered stronger institutions and supply chains that will serve us better going forward.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about the difference between the roles of quality assurance and quality control.

The GEA kytero combines the high performance of larger GEA stainless-steel pharmaceutical centrifuges with the benefits offered by disposable components.

Relative to prior models, the Thermo Scientific Orbitrap Exploris MX mass detector provides reduced downtime and maintenance, superior data quality, and seamless method transfers.

ROSS VersaMix Multi-Shaft Mixers provide fast and efficient large-scale powder dispersion.

Anritsu's 10-Lane Capsule Checkweigher can inspect up to 75,000 capsules per hour.