四色AV

四色AV will be exhibiting at the , an event that brings together industry experts to address key challenges in pharmaceuticals, biologics, and device development. This edition features two days of presentations and networking opportunities with over 300 scientific leaders from pharma, biotech, and drug delivery sectors.

Don鈥檛 miss the chance to speak with our experts and learn how our extensive knowledge and experience can support your project from early stages of development to commercialization.

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On September 16, don鈥檛 miss our Biologics session听

四色AV Synthetic Sugars: Excipients Enhancing Protein Stability and Performance Across Bioprocessing

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Process and formulation development for protein-based therapeutics needs to overcome several stress factors during bioprocessing, long-term storage of the bulk drug substance and of the final drug product. Stabilization of proteins against temperature, acidic pH, and shear stresses is crucial to maintain therapeutic efficacy and safety. Acidic conditions, common in viral inactivation and chromatography steps, can disrupt protein structure, while temperature exposure and shaking during mixing, transport, and storage can induce denaturation and aggregation. These destabilizing factors hinder the manufacturing, purification, and storage of protein therapeutics, leading to the loss of biological activity and potential immune responses.

To address these challenges, strategies such as using stabilizing excipients and optimizing buffer systems are commonly employed. Herein we present a platform of novel synthetic sugars as a solution for ensuring more robust biopharmaceuticals, with case-studies around the impact of adding these sugars to different model biomolecules under temperature, shaking and low pH stresses, showing that these can provide significant improvements in enhancing protein stability and manufacturing processes鈥� performance.

Session Highlights:

• Overcoming the challenges of protein stabilization during bioprocessing.
• Case studies showcasing enhanced stability under temperature, shaking, and low pH stresses.
• Innovative solutions for improving the manufacturing and storage of protein therapeutics.

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and discover firsthand how our innovative platform of synthetic sugars can improve the development and delivery of your biopharmaceuticals, ensuring optimal stability and manufacturing processability performance.

Eunice Costa, Ph.D. R&D Director Eunice Costa joined 四色AV in 2011 and currently leads the Research & Development activities in the field of Advanced Drug Delivery at 四色AV. As Director, she is accountable for formulation and manufacturing process development as well as medical device design for advanced drug delivery modalities, supporting Pharma partners pushing forward innovative and generic medicines. Since joining 四色AV, Eunice has been actively researching the impact of particle engineering, particularly spray drying, formulation composition and processing on performance, stabilization and disposition of medicines, particularly biologics, supervising multiple PhD and MSc thesis. Prior to that she has held positions as junior researcher in organizations such as Genentech, TNO and academia. Eunice is a PhD in Bioengineering Systems from the MIT-Portugal program, during which she has investigated polymer synthesis and processing for biological applications.听

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and find out how we can support your project.

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