BioPharm International, July 2022 Issue

An SOP for electronic-records archiving is a regulatory requirement and good for business, says Siegfried Schmitt, vice president, Technical at Parexel.

Automation and digitalization work together in the digital plant.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Finding specific solutions to overcome uncertainty has led to the evolution of a new clinical trial research environment.

Industry adoption of plant-made biologics remains slow, but plant-based technology gains an advantage by mainstream exposure.

Enriching process understanding enables robust process controls.

Specialty polymers demonstrate the advantages of single-use consumables in biopharmaceutical manufacturing.

By understanding potential material change, the impact on patient safety can be understood and mitigated.

Improved real-time visibility during all segments of handling, transportation, and delivery is keeping costs low and reliability high while helping time- and temperature-sensitive biopharmaceuticals to go the distance without incident.

How dry powder techniques can overcome limitations in biologics development and delivery to broaden routes of administration and global accessibility.

Agency leaders are moving to develop a rating system to identify those drug manufacturers with more dependable production operations.

As we reach further afield in the molecular universe, we encounter new types of problems to resolve.

Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.