BioPharm International, May 2022 Issue

Complex hurdles complicate the development of emerging therapies.

Plant-based manufacturing technology gains mainstream edge in biopharmaceutical production.

Advances in therapeutic modalities and an increase in molecular complexity have led to the need for an evolution in drug delivery approaches over the years.

Workforce training is crucial for biopharmaceutical manufacturing.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

Some progress has been made, but improvements are needed when harvesting cells for cell therapies.

Understanding both the challenges and solutions of aseptic manufacturing.

This article summarizes industry views on PAT in bioprocess-related applications and presents a vision for the biopharmaceutical industry to achieve Industry 4.0.

FDA is incentivizing drug manufacturers through higher data integrity requirements.

Applying modeling methods in preclinical studies can be a powerful tool for generating data and shortening development timelines.

What are the next steps for permanent authorization of COVID-19 vaccines, treatments, and diagnostics?

Fresh insight is instrumental in the discussion of novel analytics.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

The SamuxMP enables routine quantification of empty/full AAV capsid ratios

Sartorius’ Sartolab RF|BT 150–1000 vacuum filtration units provide fast, high-capacity filtration.

Spring has returned, and with it comes INTERPHEX.