Newsletter | August 12, 2021

08.12.21 -- Patent Transparency: The Revamped Purple Book

Featured Editorial
Industry Insights
Is Your Biologics At Risk For Protein Aggregation? Part 2

The manufacture of sterile injectables is fraught with risk, especially when it comes to protein aggregation in biologics drugs. We offer steps you can take to help prevent aggregation.

Quality By Design Approach To Enable High-Dose Drug Delivery With Autoinjectors

Designing self-injection systems to deliver biological drugs into the subcutaneous space has specific challenges relative to those required for the safe and efficacious delivery of traditional pharmaceuticals. A quality by design approach can manage all the unavoidable competing requirements and balance performance, robustness, and usability.

Not Everyone Loves Surprises: Know Your ADC’s Critical Quality Attributes

Combatting the challenges of developing and manufacturing antibody-drug conjugates (ADCs) requires robust product characterization throughout all phases of development.

Intensifying Upstream Processing: Implications For Media Management
Biopharmaceutical development and production require the investment of significant time and resources. Manufacturing procedures must be efficient, robust, and productive to minimize failure risk and ensure targets are met. In this e-book we discuss the benefits of implementing process intensification (PI) before exploring the potential implications on media management. We then outline the value in conceptual design to assist with the logistics of the media journey. Finally, we review the feasibility of implementing different PI scenarios in both existing and new facilities.
Strategies For Intensifying Your Biomanufacturing Processes

This e-book demonstrates process intensification approaches that enable the development and production of high-quality, niche-segment drugs in a more efficient and cost-effective way. 

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