Press Room

DDF - 14th American Drug Delivery & Formulation Summit

Start
Monday, September 16, 2024 - 09:00
End
Tuesday, September 17, 2024 - 18:00
Location: San Diego, United States
Hovione presents the Biologics session delivered in the American DDF Summit, titled "Hovione Synthetic Sugars: Excipients Enhancing Protein Stability and Performance Across Bioprocessing", during the event, September 16-17

Hovione will be exhibiting at the American Drug Delivery & Formulation Summit (DDF), 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’t 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’t miss our Biologics session 

Hovione Synthetic Sugars: Excipients Enhancing Protein Stability and Performance Across Bioprocessing

 

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’ 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.

 

Schedule a meeting with our experts 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, R&D Director of Hovione

Eunice Costa, Ph.D.

R&D Director

Eunice Costa joined Hovione in 2011 and currently leads the Research & Development activities in the field of Advanced Drug Delivery at Hovione. 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 Hovione, 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. 

 

Schedule your meeting today and find out how we can support your project.

Find more about DDF Summit.

 

As a fully integrated CDMO we provide optimal solutions for your drug product with the right scale and flexibility - Learn more 

 

 

 

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The CDMO’s New Jersey manufacturing site expansion will eventually cover more than 200,000 square feet. Portugal-based contract development and manufacturing organisation (CDMO) Hovione has completed an initial $100 million investment round in its East Windsor, New Jersey site. Once completed it will increase the facility’s footprint to more than 200,000 square feet and more than double its capacity for spray drying. Hovione CEO Jean-Luc Herbeaux said: “Since launching our New Jersey operations in 2002, Hovione has been one of the longest established European CDMOs in the United States. “This investment reinforces Hovione’s leadership in spray drying – a core technology platform where we have built extensive know-how and capabilities. By continuing to advance our platforms and expand capacity in the US, we are strengthening the foundation that enables our partners to bring complex medicines to patients more efficiently.” Spray drying is an increasingly important particle engineering technology for improving drug bioavailability through the amorphous solid dispersion (ASD) that can address bioavailability or crystallisation challenges. The initial phase of Hovione’s expansion will include a 31,000-square-foot building to house two size-3 spray dryers (PSD-3) designed for ASD production. Construction at the New Jersey site is already underway and the company plans to start GMP operations in the second quarter of 2026. The initiative is part of Hovione’s long-term strategy to grow its US operations and enhance its integrated drug substance, drug product intermediate and drug product capabilities. Herbeaux said: “This investment addresses growing customer demand for US-based capacity and integrated solutions that shorten development timelines and reduce tech transfer complexity. By consolidating development, scale-up, and commercial manufacturing within a single quality and governance framework, we provide customers with seamless execution from drug substance to drug product.” The company’s New Jersey expansion fits into its wider international growth plan that also includes capacity investments in Ireland and Portugal as it seeks to create a network of autonomous sites spanning the development and commercialisation of APIs, drug product intermediates and drug products.   Read the full article at EuropeanPharmaceuticalReview.com  

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