BioPharm International, January 2022

Warp speed is amazoning pharma practices and protocols.

Survey respondents reflect on the state and future of the bio/pharma employment.

Although mRNA and viral vector vaccines have been top of mind for COVID-19 treatments, other technologies and treatments are emerging—along with new variants.

Modeling techniques can improve process control and monitoring in biopharmaceutical production.

Upstream processing is better optimized with the help of automated workflows.

Enhancement of resin technology can improve the ability of chromatography to purify the growing landscape of increasingly complex biomolecules.

Qualified algorithms enable validation of machine learning models that can be used for process optimization.

As regulators balance pandemic tasks and rethink procedures, quality at manufacturing facilities is still a priority.

New and emerging biotherapeutic molecules drive the need for innovative solutions to meet cold-chain requirements.

Recent developments in the outsourcing industry include a focus on early development services, biosimilar production, and RNA technology.

Multispecific analysis is complex but can be achieved using appropriate strategies.

Siegfried Schmitt, vice president Technical at Parexel, discusses the difficulty of operating non-GMP and GMP quality systems in the same facility.

To maintain smooth operations, FDA is relying on swift reauthorization of industry-paid user fee programs.