09.14.23 -- Navigating The Murky Waters Of Patent Claims Involving AI After Amgen v. Sanofi

As more new biologics achieve market acceptance, the need for reliable, demonstrable temperature control during shipping has underscored the importance of a robust, reliable chain of custody.

Manufacturing requires a high level of precision and accuracy to ensure product safety and efficacy. Here, we explore eight benefits that vision inspection brings to the world of manufacturing.

Knowing how to use USP <1062> helps manufacturers manage the wide variety of factors that can exacerbate production costs, or result in no product at all.

As highly potent active pharmaceutical ingredients become increasingly common across the industry, it is critical to work with partners who use a risk-based approach to ensure safety and quality.

Review a full life cycle safety structure that ensures the highest standards of operator protection from single-use flexible film containment systems.

The biopharmaceutical industry is focused on maximizing the effectiveness of early-stage candidate assessments to predict a molecule’s chances of success before investing heavily in that molecule.

As cell and gene therapies proliferate across the pharmaceutical industry, drug sponsors must determine how to successfully navigate evolving regulations, study design considerations, and a lack of animal models.

Examine how leveraging a logistics partner with global end-to-end solutions can help avoid costly delays, ensure high product quality, and accelerate impactful solutions for patients worldwide.

Learn how the accuracy (melting temperature and heat of fusion) and utility of differential scanning calorimetry data is greatly diminished for materials that undergo apparent melting, and much more.

To evaluate mixing performances across new equipment and consumables to ensure consistency, CFD is invaluable in determining the performance of single-use mixers during process development.

Twin screw feeders can provide consistent and metered delivery of dry powders directly into coating equipment.

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

Physiologically based pharmacokinetic (PBPK) modeling is a powerful tool for clinical trial design that can be leveraged alongside early development experiments to reduce costs and time-to-market.

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.