04.25.24 -- Designing Highly Agile Bio/Pharma Manufacturing Facilities

Dissect the reasons for capacity bottlenecks stemming from process development scope, downstream chromatography, and equipment constraints, and delve into the potential solutions associated with each.

Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

Gain deeper insights into the implications and intricacies of this regulatory transformation by tuning in to this podcast featuring expert analysis from Terrance Thiel.

Late-stage clinical trial failures usually result in exposure with regard to capital equipment purchased to manufacture that product at a commercial scale. But what to do with this brand new, surplus equipment?

Some manufacturers still have reservations about adopting X-ray inspection as a safe method of product inspection. Explore the potential effects of X-ray inspection on pharmaceutical products and more.

Learn what punch length is, how to measure it correctly, and how wear affects length and tablet consistency. 

Navigating NCE development can be daunting. Learn about the importance of assessing and mitigating risk at every stage of development and ensure that your NCE has the maximum potential for success.

Assessing outsourcing partners’ credentials in people, technology, supply chains, and integration will make all the difference as sponsors aim to streamline processes on the path to commercialization.

Here, we will analyze and explain different containment methods and help determine which would be most beneficial for your first (or next) containment device to ensure personnel protection.

Strict regulations regarding the manufacture of HPAPIs require that pharmaceutical companies and CMOs carefully select equipment, outline processes and deploy appropriate containment strategies. 

A uniquely modified cyclodextrin is emerging as a versatile and indispensable tool for development. Explore how the right formulation approach can enhance drug delivery and improve patient outcomes.

Highly potent materials bring additional challenges to manufacturing processes. Examine considerations for optimizing HPAPI production methods to reduce risk and deliver therapies to patients with speed.

The pros and cons of soluble and insoluble processes: isolating, solubilizing, and properly refolding, and strategies to improve the performance of IB processes.