Pharmaceutical Technology, February 2022 Issue

Analytical approaches must keep pace to ensure the identity, safety, and efficacy of evolving mRNA candidates.

In this study, researchers evaluated the colloidal microcrystalline cellulose (cMCC) suspending agent—a co-processed material of microcrystalline cellulose and sodium carboxymethyl cellulose (NaCMC)—by using a representative pharmaceutical-grade commercial version of cMCC.

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.

Interest in natural phytochemicals or synthetic derivatives of cannabinoids has risen.

Training is crucial for supporting GMP operations in commercial-scale bioprocessing.

Getting started with a PAT framework enables automation with digital technologies.

For some manufacturers, the goal was to be fully compliant with the DSCSA, including both serialization and aggregation, from day one.

With data integrity regulatory violations on the rise, there is a need for better and more consistent validation management practices.

Automated analytical workflows require advanced technologies to manage the higher volume of data output.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual.

As Europe moves closer to implementation of ISO IDMP standards, the bio/pharma industry is accelerating efforts to manage its data and documents more effectively.

The global nature of the COVID-19 pandemic emphasizes the critical importance of expanded vaccination.

The Digital Markets Act is transforming the use of digital content by the pharmaceutical industry.

As company revenues are gaining a boost from COVID-19, the issue of pricing is being debated once more.

The process of reshaping inevitably leads to fresh insights.

The ROSS VersaMix Triple Shaft Mixers offer fine dispersion, deagglomeration, emulsification, temperature control, and degassing.

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.

Thermo Fisher Scientific's Triple Wrap Plates possess a unique Vapour-phase Hydrogen Peroxide (VHP) indicator for enhanced sterility and complete clean room and isolator confidence.

Busy is good for business.