In-depth analysis of the critical issues impacting the full spectrum of the pharmaceutical manufacturing value chain.
In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey.
The FDA cut back inspections in 2020 due to COVID-19 and reverted to remote inspections and alternative tools, but what has been the impact? The FDA conducted 52 domestic inspections from March to September 2020, compared to about 400 in prior...
Which biologics are slated for the strongest sales growth in 2021, and how do they compare with sales growth for small-molecule drugs? What biologics were approved as new molecular entities in 2020, and which drugs are slated for future blockbuster...
What may be in store for the pharma industry in 2021? What trends will continue and what will emerge? From telemedicine to new models in drug development, to supply-chain adjustments, to increased deal-making, DCAT Value Chain Insights takes the...
President Joe Biden issued a “Made in America” executive order this week (January 25, 2021) for federal procurement of goods, materials, and products. It includes establishing a Made in America Director in the Office of Management and Budget and...
Today, biopharma companies face growing challenges when capacity is at a premium. Investment decisions must be made to ultimately determine the expansion of facilities, headcounts and technology choices necessary to maintain supply. Discover the...
The European Commission’s Pharmaceutical Strategy for Europe calls for a structured dialogue to identify vulnerabilities in the pharma supply chain and provide policy options to strengthen medicines supply in the EU, including reducing EU...
In 2020, the FDA approved 53 new molecular entities (NMEs), the second highest level of NMEs approved in a given year in the past decade and over the 48 approvals in 2019. What drugs were approved, and what was the mix between small molecules and...
The COVID-19 pandemic has obliged a re-evaluation of manufacturing networks and supply lines. An upcoming DCAT webinar, Pharma’s Manufacturing and Supply Lines: New Ways for Risk Mitigation Post COVID-19, provides thought leadership on what...
The CDMO industry enters 2021 in the strongest position it has ever been in. The industry has reaped substantial benefits from government responses to the COVID-19 pandemic, especially those measures meant to maintain economic activity, but size...
