Hovione

Join Hovione experts to gain insights on novel formulation development strategies for DPIs and learn how to improve your drug delivery efficiency even at high drug loads

https://www.pharmtech.com/pte_w/dpi-delivery

This webinar will address the most relevant solutions for dry powder inhaler (DPI) development covering both formulation and device development, as well as process optimization and analytical characterization, under an integrated development approach. DPIs are the dosage form of choice for delivering high payloads of inhaled drugs and achieving maximum delivery efficiency to patients. This presentation will focus on new formulation platforms, aiming to address the pharmacokinetics requirements of the target drug and indication, coupled with a new device platform, the Sunriser® DPI. This integrated approach is designed to maximize drug delivery efficiency while maintaining safety, being able to address a diversified array of diseases.



Gain insights on novel formulation development strategies for DPIs, to be able to improve drug delivery efficiency even at high drug loads;

Understand the potential of wet milling and dry milling capabilities for boosting the fine particle dose of DPI formulations;

Discover analytical characterization techniques, for differentiated formulations, to further understand product properties that impact drug delivery and aerodynamic performance;

Understand features associated with a novel high efficiency device platform, the Sunriser® capsule-based Dry Powder Inhaler;

Network with industry peers and experts during the live Q&A session.

Pharmaceutical researchers and scientists

Business development, portfolio management and technology licensing experts

Inhalation product development professionals


R&D Manager, Inhalation and Advanced Drug Delivery
Hovione

Susana Saldanha is the manager of formulation and device development team, in the Inhalation and Advanced Drug Delivery Group at Hovione R&D. Susana has over 10 years of experience in formulation development and has supported the development of oral, transdermal, and injectable dosage forms, spanning from early drug product development through product registration to launch.
Susana joined Hovione in 2018 where she focused not only on drug delivery to the lungs but also nasal and ophthalmic drug delivery. She has worked on drug product development projects from early to later stages, ranging from generics to innovative products. Susana holds a PharmD from Faculty of Pharmacy, University of Coimbra.




R&D Manager, Analytical development
Hovione

Sofia Silva is a senior manager in the Analytical development group at Hovione R&D. Sofia has over 15 years’ experience in analytical chemistry development specializing in inhalation drug products, from early to late phase development and drug product launch.
Sofia joined Hovione in 2009 and holds master’s degree in Pharmaceutical Sciences and Pharmaceutical Engineering.

Webcasts

Webinar Date/Time: Wed, Oct 4, 2023 - 11:00 am EDT | 4:00 pm GMT | 5:00 pm CEST | 8:00 am PDT

High Performance Solutions for Dpi Delivery: New Formulation and Device Platforms

Join Hovione expert to understand the advantages of working with a CDMO when implementing continuous tableting (CT) and learn more about the technology-driven advantages of a CT-based program.

https://www.pharmtech.com/pte_w/continuous-tableting

The webinar, focused on continuous manufacturing of oral solid dosage forms, also known as continuous tableting (CT), will introduce the concept of working with a CDMO to develop and launch a CT-based program. The discussion will focus on the business case for continuous tableting in the context of working with a CDMO. Intrinsic technology-driven advantages such as higher product quality, greater supply chain flexibility, opportunity to accelerate time-to-market and ability to implement advanced process control as well as those that manifest from working with an experienced CDMO will be shared.

Learn about important considerations when implementing Continuous Tableting – advantages and challenges.

Understand the advantages of working with a CDMO for a Continuous Tableting based program. This includes new products as well as batch to continuous conversions.

Case studies will be presented showing how big data sets generated in Continuous Tableting enable the implementation of process improvements.

Individuals and organizations who are curious to learn about technology, its fundamental benefits and challenges.

Current and aspiring practitioners of the technology who are interested about the implementation of Continuous Tableting at a CDMO.


Production Senior Manager, Drug Product Continuous Manufacturing
Hovione

 is a Senior Manager at Hovione where he heads the technical services group for Hovione’s continuous drug product manufacturing installation (CT501) in East Windsor, New Jersey, overseeing three technical functions, namely PAT, Process Development and Investigations. In his prior role at Hovione, Dr. Oka was responsible for manufacturing operations in addition to the aforementioned functions, where he successfully led the validation and tech transfer of a commercial program from one of Hovione’s partners to CT501. The program received approval from the US FDA and Dr. Oka was the technical lead for the area during the associated PAI(s). Dr. Oka started his career at Hovione as a process development engineer where he supported the installation and qualification of CT501. Dr. Oka received his PhD in Chemical Engineering from Rutgers University. His thesis focused on continuous powder mixing and granulation and examined the role of continuous manufacturing in enabling direct compression of otherwise directly incompressible formulations. He was part of the team at Rutgers University and NSF ERC-SOPS that helped develop Prezista®, the first FDA approval for a batch-to-continuous conversion of a drug product. Dr. Oka holds a BS in chemical engineering from Mumbai University.

Webinar Date/Time: Wed, Oct 11, 2023 - 11:00 am EDT | 4:00 pm GMT | 5:00 pm CEST | 8:00 am PDT

Accessing Continuous Tableting Through a CDMO

Follow the complete journey of amorphous solid dispersions (ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

https://www.pharmtech.com/pt_w/early-formulation



Welcome to the third and last webinar of our 3-part webinar series 

"Amorphous Solid Dispersions by Spray Drying: From Early Formulation to Commercial Lifecycle Management."

(ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

After presenting Hovione’s formulation screening and scale-up methodologies for amorphous solid dispersions (ASDs) by spray drying, the webinar series will conclude by discussing the link between development, process validation and lifecycle management.



 will explain how to perform a critical and extensive evaluation of potential failure modes, how to carry out risk assessment and how to define criticality, to enable a successful Process Performance Qualification (PPQ).

Commercialization of ASDs requires statistical tools and methodologies to enable the continued process verification (CPV) application and ensure that the process remains under control. In this session, participants will gain insights into the importance of continuous improvement supported by continuous data analysis. The speakers will also outline the importance of commercial experience when using spray drying to produce ASDs. Case studies, namely regarding post approval changes, will be presented, and discussed.




Learn how to apply Quality Risk Management tools to get a successful Process Validation while ensuring a robust commercial stage

Learn how statistical tools support the commercial lifecycle enhancing process control and product quality

Discover how Continued Process Verification (CPV) and Product Quality Review (PQR) are key for a continuous improvement strategy



This webinar is suitable for anyone working in formulation and process development of amorphous solid dispersions, procurement, and outsourcing teams or project managers, who are interested in understanding the end-to-end process for validation and commercialization of an ASD by Spray Drying.



Hovione experts featured in this webinar will be available to answer your questions during a live Q&A.

Don't miss the other sessions in the series!

Session 1: Evaluating the Best Formulations for Amorphous Solid Dispersions by Spray Drying

Session 2: ASDs by Spray Drying: Process Development & Scale-Up


This event is now available on demand.





The Hovione team presents a new comprehensive three-part webinar series on 

"Amorphous Solid Dispersions by Spray Drying: from early formulation to commercial lifecycle management" 

starting February 28, 2023.

Over the course of this series, 

Hovione experts will guide participants 

(ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

As an experienced manufacturer of ASDs by spray drying for the pharmaceutical industry, Hovione will be able to share its extensive knowledge and experience. Furthermore, the featured experts will be available to answer your questions during a live Q&A.




Gain knowledge on designing a successful formulation for Amorphous Solid Dispersions produced by Spray Drying

Discover how to develop a robust process at lab scale and assure a successful scale-up

Learn how to use a model-based methodology to establish the design space and a commercial process

Understand what to consider during the Lifecycle Management of a commercial Amorphous Solid Dispersion by Spray Drying


Quality Assurance Specialist Site QA
Hovione

 is a Quality Assurance specialist at Hovione’s Site QA area. She joined Hovione in 2017. During four years she led ASD projects as a QA specialist and after that she joined the Drug Product Formulation group, as the QA assigned for Continuous Manufacturing. Currently, she is a subject matter expert on topics such as data analysis and statistical tools. With a great interest in digitalization, she has been enabling the implementation of Automatic Reports, such as the Product Quality Review.

Inês holds a Master’s degree in Pharmaceutical Sciences from Faculdade de Farmácia, Universidade de Lisboa.




R&D Manager, Particle Engineering Corporate Technical Services
Hovione

is an R&D Manager in the Particle Engineering team, which is integrated within the Corporate Technical Services. Tiago joined Hovione in 2014. He has focused his research on first principle models and data science to establish model-based methodologies to expedite spray drying process development. Recently, his work has been dedicated to the post-approval stage particularly to how data, models, and prior knowledge can be applied for continuous improvement, while also focusing on risk review during lifecycle management.

Tiago holds a Ph.D. in Engineering Design and Advanced Manufacturing from the University of Lisbon and is the author of two patents.

Webinar Date/Time: Thursday,  April 20th, 2023    
4:00pm GMT   |   11:00 am EDT     |   5:00 pm CEST 

Commercial Reality and Lifecycle Management of ASDs

ASDs by Spray Drying: Process Development & Scale-Up


The Hovione team presents a new comprehensive three-part webinar series on 

(ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

As an experienced manufacturer of ASDs by spray drying for the pharmaceutical industry, Hovione will be able to share its extensive knowledge and experience. Furthermore, the featured experts will be available to answer your questions during a live Q&A.



Manager
R&D Oral Drug Product - Process
Development Team | Hovione

.is part of the R&D Oral Drug Product Development group. She is the Process Development team Manager who is responsible for the development of Spray Drying and Tableting late-stage programs for oral delivery. She joined Hovione in 2016 as a Scientist, and she began her focus on particle engineering and solubility enhancement programs. She has been involved in several spray drying processes from early stages until validation. Between 2018 and 2022 she managed the Operations team within the Oral Drug Product Development group, which was responsible for providing support to all of the activities related to the laboratorial process development that covered areas such as inhalation, pre-formulation, ASD screening, spray drying, and roller compaction/tableting (batch and continuous).

Clara holds a Ph.D. in Refining, Petrochemical and Chemical Engineering and is the author of five papers and one patent.

Director
Technology Intensification |
Hovione

 joined Hovione 12 years ago and has evolved from R&D engineer (developing processes across all scales of spray drying) to the business area, becoming a Senior Manager for Particle Engineering Services. He led the company's Knowledge Management and Innovation areas for two years, and in between 2018 and 2021 he was based at Hovione’s site in the USA to support the installation, qualification, and kick-off of the GMP operations of a new Continuous Manufacturing rig. In 2021 he took on the role of Director of the Continuous Tableting Center for Excellence, based in Lisbon, overseeing the company's drug product Continuous Manufacturing efforts across all sites. In 2022, José moved on to become the Director of Technology Intensification, with the goal of maintaining Hovione among the world’s leading organizations in spray drying and continuous tableting services. José holds a Ph.D

in Chemical Engineering. He has extensive senior management experience over two geographies (Portugal and USA) and he is the author of sixteen papers, one book chapter, and four patents.

(ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

https://www.pharmtech.com/pte_w/solid-dispersions

The Hovione team presents a new comprehensive three-part webinar series on 

(ASDs), starting from the early formulation stage to process development and scale-up, and finally to commercial reality and lifecycle management of ASDs.

As an experienced manufacturer of ASDs by spray drying for the pharmaceutical industry, Hovione will be able to share its extensive knowledge and experience. Furthermore, the featured experts will be available to answer your questions during a live Q&A.


 kick-off the series by focusing on the role of amorphous solid dispersions in modern oral drugs and how the right formulation for a drug candidate can be selected using Hovione’s proprietary screening methodology. This method is performed via an automated high-throughput system that was developed over many years of experience with formulation of ASDs. The speakers will provide an understanding of the methodology, the evaluation process, and the studies typically utilized, as well as key information needed to make a formal assessment of the best candidates. 

Senior Scientist
R&D, Analytical Development

 is a Senior Analytical Scientist specialized in drug development tools for pharmacology and toxicology studies, with over fifteen years of laboratory and research experience and over five years of team leadership in applied research. He integrates the Department of Analytical Methodologies & Method Development at Hovione since 2022, where translational and applied research supports the development and quality assurance of active pharmaceutical ingredients, excipients, and drug products.

Alexandre holds a Ph.D. in Biomedical Engineering at Carnegie Mellon University. After a postdoctoral training in cardiac microengineered cellular systems with human induced pluripotent stem cells at Stanford University and the Gladstone Institute of Cardiovascular Research, he led the Integrated Cellular Systems Laboratory at the FDA for five years.

Scientist
R&D Oral Drug Product -
Formulation Group

 joined Hovione’s R&D Oral Drug Product Development group in 2020 as a formulation scientist. She has been involved in early-stage development covering preformulation, ASD screening, spray drying, and roller compaction/ tableting. Before joining Hovione, she was an academic researcher in Analytical Chemistry.

Inês holds a PhD in Pharmaceutical Sciences from Faculdade de Farmácia, Universidade do Porto, focusing on the development of green immunoanalytical methods using miniaturized fluidic devices. She also has a master’s degree in Pharmaceutical Sciences, involving research on API synthesis and physicochemical characterization.

Scientist R&D Oral Drug Product -
Formulation Group
Hovione

 is a formulation scientist in the oral drug product development at Hovione R&D. For the last 4 years Pedro has been working in the pharmaceutical industry, initially as a modelling scientist and later as a formulation scientist. Yearly years focused on innovation and development of automated equipment for screening of ASD’s.Pedro has a master’s degree in Aerospace Engineering from Instituto Superior Técnico, Lisbon, with a specialization in fluid mechanics.

Webinar Date/Time:

Session 1: Evaluating the Best Formulations for Amorphous Solid Dispersions by Spray Drying: Tuesday, February 28th, 2023 4:00pm GMT | 11:00 am EDT | 5:00 pm CEST 

Session 2: ASDs by Spray Drying: Process Development & Scale-Up: Wednesday, March 22nd, 2023 at 4pm GMT | 11am EDT | 5pm CEST 

Session 3: Commercial Reality and Lifecycle Management of ASDs: Thursday, April 20th, 2023 at 4 GMT | 11am EDT | 5pm CEST 





Amorphous Solid Dispersions by Spray Drying: From Early Formulation to Commercial Lifecycle Management

https://www.pharmtech.com/pt_w/Dispersome

Poor drug solubility is one of the most challenging issues in drug development. Up to 90 % of all newly discovered drugs show insufficient aqueous solubility in their crystalline form, resulting in too low bioavailability, because the drug must dissolve in order to be absorbed and reach its pharmacological target. Many promising drug candidates are thus discontinued during early-stage development due to poor bioavailability resulting from low solubility.

The Dispersome® technology is a novel solubility enhancing approach that is based on using the protein beta-lactoglobulin (BLG) as novel pharmaceutical excipient. By mixing a drug compound with this by-product from cheese production, a unique amorphous composition of small molecule drugs and proteins is obtained.

The technology has been shown to dramatically increase the solubility and bioavailability of poorly-soluble drugs, which is demonstrated by case studies. These co-amorphous drug-BLG formulations can be manufactured by spray drying. In this presentation, a roadmap of the spray-drying development process, including solution preparation, spray drying and secondary drying, will be covered. Considerations are made on both, formulation and manufacturing processes, all of which are important to bring these new formulations from the laboratory to production scale.

A focus will be given to the importance of lab-scale familiarization and supporting studies throughout the development process as well as how computational, statistical tools combined with prior knowledge can be capitalized to reduce risk while maximizing time and resources.



Innovation in bioavailability enhancement using BLG

Amorphous stabilization using proteins as excipients

How formulations can be scaled up to meet commercial supply demand



This webinar is targeted at scientists and managers working in the field of pre-formulation, formulation, and CMC. The webinar has a focus on solid oral dosage form development for poorly-soluble drugs.

Pedro Valente
Oral Drug Product Development
Hovione

Dr. Pedro Valente is the director of oral drug product development at Hovione R&D, specializing in formulation, particle engineering, and process development of pharmaceutical drug products for oral delivery. Prior to joining Hovione as an R&D scientist in 2015, Pedro worked as aerothermodynamics engineer at Volvo Aero Corp. in Sweden (now GKN aerospace) and later on was an invited lecturer and researcher at the University of Lisbon, covering the areas of fluid mechanics and turbulence. Valente holds a PhD from Imperial College London (UK) in aeronautics and MScs from the U. Lisbon, Portugal (Mech. Eng.), and from Chalmers Technical University, Sweden (fluid dynamics and turbulence).

Dr. Korbinian Löbmann is the CSO at Zerion Pharma, a university spin-out that he co-founded in 2019. He has more than 10 years of experience in solid formulation and dosage form development, including preformulation, formulation, processing, and manufacturing together with the relevant solid-state characterization and quality control. This includes the development of new enabling formulation strategies for poorly soluble drugs using amorphous drug delivery systems. Löbmann received his PhD in pharmaceutical sciences in 2013 from the University of Otago, New Zealand and then joined the University of Copenhagen, where he was appointed assoc. prof. in 2017. He has authored more than 100 peer-reviewed papers and patents.

Thursday, September 8, 2022 at 11am EDT; 4pm GMT; 5pm CEST
This webinar will highlight the new solubility enhancing Dispersome® technology, which is based on the amorphous stabilization of a given drug using the protein beta-lactoglobulin (BLG) as novel pharmaceutical excipient. Several relevant case studies are presented to showcase the potential of this new technology. Subsequently, the webinar provides a roadmap on how these formulations can be manufactured on a commercial scale. The webinar will also cover the manufacturing of the formulations.

Hovione

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