BioPharm International Sponsored eBooks

As bio/pharmaceutical companies navigate the capacity and supply chain challenges presented by the COVID-19 pandemic, attention also needs to be focused on emerging and established quality and regulatory challenges.

In this Regulatory Sourcebook, the editors share the latest insight and analysis for regulatory and industry trends, supply chain issues, and quality best practices including the following:

• Innovation and FDA’s Focus Areas of Regulatory Science report
• Serialization
• Counterfeit COVID-19 vaccines
• CMC strategies
• Data integrity
• Intellectual property

Biopharmaceutical companies are tasked with doing more with less while moving promising biotherapeutics into the clinic as fast as safely possible. Advances in High-Throughput Upstream Process Development takes a deep dive into an approach that addresses this challenge: combining definitive screening designs with advanced machine learning for accelerated drug development. Explore:

• Phase appropriate DOE strategies to minimize development timelines and maximize product life-cycle efficiency
• Efficient sample transfer from bioreactor to analytical platform
• Organizational strategies for data management from research to GMP production

Bioprocess scale-up is an essential step in the journey toward commercialization, but it can take tremendous effort to ensure production performance is not lost in the process. Addressing Bioprocessing Scale-Up Challenges highlights new technology intended to streamline and optimize bioprocess scale-up. Explore:

• Innovative technology delivers time and cost savings during bioprocessing scale up.
• Optimized scale-up of Escherichia coli fermentation from small to pilot scale
• How the new Scale Up Assist feature of the BioFlo 720 Bioreactor Control System can help your antibody production workflow

This paper includes a brief introduction to light scattering instruments and techniques, and how they are coupled with fractionation techniques. For several classes of vaccines – including subunit vaccines, mRNA-LNPs, polysaccharide conjugates, and plain old viruses – case studies demonstrate the utility and breadth of analyses using the light scattering toolkit. These include measuring size distributions, characterizing protein-protein binding, and quantifying glycan content in glycoproteins or nucleic acid cargo in nanocarriers. Multiple ways to detect aggregation and other measures of stability are also described.