Pharmaceutical Technology, August 2023

Laboratories are focusing on more automated processes while also trying to maintain an efficient, safe, and personalized experience with each analytical test.

Quality Quartets may be used to achieve knowledge-driven, risk-based approaches to commissioning and qualification that are consistent with ICH Q9(R1) principles.

The biggest hurdle is developing palatable formulations that are efficacious and patient friendly.

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

A comprehensive understanding of what makes mRNA vaccines tick is crucial in charting the future of the market.

The industry is taking steps to automate the final product inspection process for complex therapeutics.

More than a third of CMOs are struggling to keep skilled technical and production staff.

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

Only a significant joint effort across the supply chain will help to make healthcare more sustainable and reduce the impact of climate change on global health.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

mRNA may be a modality whose chief advances are yet to come.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.

Mapping America’s Pharmaceutical Supply (MAPS) Act aims to establish a database including key information about critical drugs so supply chain weaknesses can be identified.

The ROSS Model CDA-200 is fitted with multiple agitators for semi-continuous operation.

Sphere Fluidics’ Cyto-Mine is an automated cell line platform that is designed to enable screening of up to 40 million cells over the course of several hours.

Eurofins Genomics Blue Heron IVT mRNA synthesis service is designed to provide researchers a customizable solution.

Thermo Fisher Scientific’s Gibco OncePro Tumoroid Culture Medium Kit was specifically developed for the expansion of patient-derived tumoroids from multiple cancer indications.