12.21.22 -- New Year For Novo Nordisk's Wegovy Supply Challenges

Biopharma 4.0 encompasses several key innovations, including the widespread automation of business processes within a company, comprehensive data integration, and data interoperability between manufacturing and operations.

Improving your ADC’s chance of clinical success requires an understanding of what potential obstacles lie ahead and what capabilities and expertise are necessary to overcome them.

The success of using viral vectors to deliver a molecular payload into a cell or replace defective genes with functional ones is an inflection point in the future of modern medicine.

Learn how a modern manufacturing execution system (MES) is using digital production records to help manufacturers regulated by the FDA improve their quality and efficiency goals.

Evolution of the biosimilar regulatory pathway will require manufacturers to ask critical questions about the implementation of legacy and novel technologies and procedures in downstream processing.

Market dynamics will continue to favor engaging with CDMO partners who have the capabilities and experience to manage and quickly respond to short-term needs while anticipating and planning for long-term requirements.

There is increased demand for lyophilization services in the manufacturing of new biologic drugs and injectable formulations as well as in change of formulation presentation.

Softgels are a popular dose format among consumers, thanks to their high swallowability and quick onset of action, yet pharmaceutical developers may not even consider them. Why the disconnect?

This guide explores the regulatory strategy considerations sponsors should bear in mind when working with global regulation agencies, with a focus on the development of drug and biologic products.

Understand how the supply chain experience, severely affected by COVID-19, involving global workforce disruption, surging demand, and drug shortage notices, is shaping attitudes toward resilience.

Using a model T-cell line, we demonstrate the impact of varying rinse volume, intermediate volume, and manual extraction parameters on overall cell recovery with a final product dose volume of 20 mL.

Despite the growing body of research and scientific knowledge, perhaps the biggest challenge with LNP formulation is the journey into the unknown.

Drs. Joachim Klein and Rebecca Michael from Lonza Pharma & Biotech answer attendee questions from a recent webinar about Lonza’s options for expressing and manufacturing complex biologic drugs.

Should CDMO partner size influence selection for your large molecule project? To choose the best CDMO for you, here are a few reminders to help you look beyond size.

Experts discuss key considerations and three primary challenges faced during the development and manufacture of highly potent oral solids.

The benefits of continuous flow manufacturing are significant and numerous, and those benefits grow with each technological breakthrough and methodological advance.

Explore case studies and findings to help ensure project success and address challenges and risks faced during new product processes and technology transfers in the industry.

To overcome growth condition variability and the plotting of titration curves to measure any effect on the targeted mechanism of action, explore a modeling tool to predict cellular response.