Press Room

DDL 2023

Start
Wednesday, December 06, 2023
End
Friday, December 08, 2023
Location: Edinburgh, Scotland
Booth Number: #165

Hovione is excited to participate in the DDL Conference 2023 from December 6-8 in Edinburgh. Don't miss the opportunity to engage with our experts in inhalation and nasal drug delivery and discover how our comprehensive expertise and leadership in Particle Engineering can ensure that your inhalation and nasal therapies are engineered for success from start to finish.



Join Hovione's Presentations



On December 7th, don't miss the oral presentations by our experts:

 

Title: "Enhanced Lung Delivery of mRNA Using Nebulized Lipid Nanoparticles"

Ricardo Velez, Associate Scientist, IADD 

Time: 14:40 - 14:55

Description: The current study developed a formulation of lipid nanoparticles (LNPs) that encapsulate either messenger RNA (mRNA) or transfer RNA (tRNA), enabling their delivery into the lungs through nebulization. tRNA-LNPs and mRNA-LNPs were produced using microfluidics, followed by a buffer exchange via dialysis to investigate the effect of different excipients on LNPs colloidal stability during nebulization. The formulation containing PBS and Tween 80 demonstrated the capacity to sustain the colloidal stability of tRNA-LNPs during nebulization. This formulation was then applied to mRNA-LNPs, maintaining particle colloidal stability and mRNA integrity throughout the product's lifecycle. 

The mRNA-LNPs were nebulization using a vibrating mesh nebulizer and produced droplets with favorable aerodynamic characteristics: Median Mass Aerodynamic Diameter (MMAD) of 4.6 µm, a Fine Particle Fraction of Emitted Dose (FPFED) of 51%, and an Emitted Dose (ED) of 92%. By presenting a formulation capable of withstanding mechanical stress induced by a vibrating mesh nebulizer while exhibiting satisfactory aerodynamic performance, this work is a significant advancement in the nebulization of nucleic acids.

 

Title: "Amorphous Spray Dried Microparticles for Nasal Delivery: Tackling Solubility Challenges while Targeting Systemic Nasal Absorption"

Patrícia Henriques, Scientist, Inhalation and Advanced Drug Delivery

Time: 14:55 - 15:10 

Description: Dry powder formulations for nasal drug delivery can be manufactured by spray drying, a technology that allows particle size control and the generation of amorphous solid dispersions for drug solubility enhancement. The objective of this study was to characterize the dissolution and drug release performance of amorphous spray dried microparticles comprising a model poorly soluble drug piroxicam and two different polymers, while comparing with the corresponding physical blends. The lead formulation was further characterized regarding nasal deposition using the Alberta Idealized Nasal Inlet (AINI). Overall, the results show spray drying as an advantageous technology for nasal targeted systemic delivery. Moreover, a combined performance evaluation using dissolution, drug release and nasal deposition methodologies was adequate to characterize and select lead formulation candidates.

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Don't Miss Hovione's Poster Sessions 

Poster Title: High drug load and performance formulation platform for DPI

Susana Saldanha, RD Manager, IADD 



Description: The work developed shows a formulation platform using crystalline active ingredient particles coated with a force control agent, such as Leucine, provides a solution for delivering high drug loads to the lungs by increasing more than 4 times the fine particle fraction (FPF) from 7% to 38% when comparing with the uncoated API particles. The results show that this formulation platform can be applied in a wide range of therapeutic indications that require high drug load inhalable powders. In addition, the combination of the formulation with a high-performance device such as Sunriser®, can further improve the delivered dose efficiency.

Poster Title: "Impact of the blending process of carrier-based formulations on DPI performance" Luis Sousa, Senior Analytical Scientist, AD 

Abstract: This work aimed at investigating the impact of blending process parameters, such as the order of addition of a pre-blend of excipients and the blending energy, on the aerodynamic performance of carrier-based formulations containing magnesium stearate. Several blends were manufactured as part of a DoE and the results revealed that no statistical model could explain the variations observed. Nevertheless, a clear correlation was observed between the API content of the blends and aerodynamic performance (Fine Particle Fraction), which was further explored with the help of thermal analysis (DSC). At the end, optimal blending process conditions were defined for this type of formulations.

 

Schedule a meeting with our team - Booth #165 - and get to know more about our unique and comprehensive expertise in inhalation and nasal drug delivery and how we can support your needs in your drug development and manufacturing.

Let’s discuss your project together.

 

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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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Hovione doubles spray drying capacity with $100m US investment round

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The latest from CDMOs, CMOs, and suppliers featuring Thermo Fisher Scientific, Lonza, SK pharmteco/Lotte Biologics, Hovione, Sai Life Sciences, BioCina, Alcami, Piramal Pharma/IntoCell and Roquette. Formulation Development/Drug Product Manufacturing: Hovione Completes Initial $100-M Investment Cycle in US Operations Hovione, a CDMO of drug substances and drug products, has completed an initial $100-million investment cycle at its site in East Windsor, New Jersey, as part of a strategy to increase its US operations and enhance its integrated drug-substance, drug-product intermediate, and drug-product capabilities. Upon completion, the site will cover more than 200,000 square feet.   The initial expansion phase includes a 31,000-square-foot building that will house two size-3 spray dryers (PSD-3) designed for production of amorphous solid dispersions (ASDs). This investment more than doubles Hovione’s spray-drying capacity in the US by expanding capabilities for ASD development and commercial manufacturing. Construction is underway at the New Jersey site, with GMP operations planned to start in the second quarter of 2026.  As part of this expansion, Hovione has also acquired additional adjacent land to enable future growth at the East Windsor site. The 125,000-square-foot greenfield will support large-scale production, including continuous and batch tableting capacity, and introduce the latest pharmaceutical technologies and digital innovation with enhanced quality control and R&D capabilities.    Read the full article at DCATvci.org  

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