Spray Drying in Life Sciences Lectures and Workshop 21-22 Feb 2019

Thu, 21 Feb 2019 - 08:15 to Fri, 22 Feb 2019 - 16:30
ProCepT and Xedev organize a unique combination of lectures and “hands-on” workshop. International Experts, daily active in the field of Spray Drying in Life Sciences from R&D to Production, exchange their know-how through lectures and challenge you with “hands-on” experiences!

Program

Day 1: Lectures

  • 9 Experts lecture about Spray Drying applied in Life Sciences. Topics: Basics of Spray Drying, Downstream processing, Amorphous Solid Dispersions, API & Biologicals, Scale-up, Nano suspensions, Nasal and Pulmonary delivery, …
  • Evening program: walking dinner through historical centre of Gent

Day 2: Hands-on workshop = SOLD OUT

  • Participants are split in small groups and are challenged to different hands-on exercises on Spray Drying equipment and Analytical instruments, in area's of Particle engineering, Formulation, Glass Transition, Powder characteristics, ... a unique chance to get your first intro in Spray Drying. 

Important: Day 1 = only few place left & Day 2 = !! SOLD OUT !!

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Practical

Participation Fee

  • Day 1: 1.000 euro pp
  • Day 2: 1.450 euro pp
  • Day 1 + 2: 2.200 euro pp
  • Gent Mariott Hotel: 159 euro per night p.p. incl. breakfast

Location

  • Day 1: Gent Mariott Hotel, Korenlei 10, 9000 Gent (Belgium)
  • Day 2: ProCepT, Industriepark Rosteyne 4, 9060 Zelzate (Belgium)

Agenda

Day 1

08:15 Registration
08:45 Welcome (Filip Van der Gucht - ProCepT - Belgium)
09:00 Introduction in Spray Drying (David York – Leeds University - UK)
09:40 Evaluation of flow properties of Spray Dried amorphous solid dispersions. Is down-stream processing prior to tableting always needed? (Lieselotte De Smet - Xedev - Belgium)
10:20 Coffee break
10:40 Amorphous solid dispersions manufacturing technologies and scale up of Spray Drying processes (Marianne Van Steenwinckel - Janssen R&D - Belgium)
11:20 The combined use of top-down particle processing and Spray Drying to engineer optimized drug particles (Mark Saunders – P2C Pharma - UK)
12:00 Lunch 
13:00 Spray Drying of Biopharmaceuticals (Sune Klint Andersen - Janssen R&D - Belgium)
13:40 Loading of mesoporous silica particles by Spray Drying for nasal formulations (Claudia Mattern – MetP Pharma - Switzerland)
14:20 Manufacturing and Characterization of inhalation products containing engineered particles produced by Spray Drying (Tomaso Guidi - Chiesi Farmaceutici - Italy)
15:00 Coffee break
15:20 In-vitro, in silico and in-vivo evaluation of Edry™, an innovative dry powder technology (Cedric Van Holsbeke - FLUIDDA - Belgium)
16:00 Open forum
16:30 End of the lectures
18:30 Walking diner in Gent 

Day 2: !! SOLD OUT !! 

08:30 Hotel pick-up
09:00 Welcome in ProCepT Zelzate
09:30 Spray Drying Hands-on Part 1
12:00 Lunch
13:00 Spray Drying Hands-on Part 2
16:30 Return to Gent or Brussels Airport

Speakers biography

Filip

Filip Van der Gucht - ProCepT - Belgium

Title

Welcome

Abstract

Warm welcome to all the participants and the guest speakers, fascinated by Spray Drying, the instant drying process allowing particle engineering on size, shape and function of the particle.

Bio

Filip Van der Gucht has a Master in Chemical Engineering Biochemistry and is CEO and co-founder from ProCepT and Xedev. Filip has built up 25 years hands-on process know-how in drying, agglomeration, mixing and coating technologies. The great Teams of ProCepT and Xedev share his passion and drive in technology and science .

David

David York - Leeds University - UK

Title

Introduction in Spray Drying

Abstract

Spray Drying began as a means of producing a dried powder product from a solution or slurry. It appeared to be a very complicated process, giving rise to a wide range of particle structures and properties-seemingly at random. However, as the science has developed it has shown itself f to be understandable, and to increasing degrees predictable by breaking it down into its component parts just like any other chemical process. This has opened up the exciting potential for deliberately engineering different particle structures, and hence properties. The aim of this talk is to introduce the basic science of drying and how it relates to the experience of droplets as they undergo drying in a Spray Drying tower. From this standpoint one can develop an appreciation as to how the structure is built up, depending on the properties of the materials, the droplet size and the process conditions. 

Bio

David is a chemical engineer with 35 years’ experience in R&D in Procter and Gamble where he worked on a wide variety of particle making processes mainly in Spray Drying, micro encapsulation and agglomeration. He has extensive experience of taking new processes from the laboratory, through pilot plant to plant commissioning. He has over 50 global patent applications (17 granted) and over 50 academic publications in a wide area. He joined Leeds as a professor in structured particulate materials in 2012, from where he continues his interests in research, teaching, and finding ways to grow more collaborative links between academia and industry- part of which involves running CPD courses in Spray Drying, Micro encapsulation as Fluid bed processing. 

Lieselotte

Lieselotte De Smet - Xedev - Belgium

Title

Evaluation of flow properties of Spray Dried amorphous solid dispersions. Is down-stream processing prior to tableting always needed? 

Abstract

Poorly soluble molecules are often Spray Dried in order to increase their solubility by obtaining amorphous solid dispersions. For the moment, these powders have the tendency to have very poor flowability characteristics and are always down-stream processed prior by tableting. As down-stream processing increases the risk of nucleation and consequently decrease the solubility (and bioavailability) of the compound, it would be very interesting if direct compression could be applied after Spray Drying.

Bio

Lieselotte De Smet studied pharmacy at the university of Ghent obtaining here PhD in pharmaceutical technology in the 2013 at the same university. She is working as a project manager since 2014 at Xedev. Here experience is in the field of formulation and process development mainly using Spray Drying in early stage development however always keeping the focus on scalability of the product and process.

Marianne

Marianne Van Steenwinckel - Janssen R&D - Belgium

Title

Amorphous solid dispersions manufacturing technologies and scale up of Spray Drying processes 

Abstract

Spray Drying is generally accepted in pharmaceutical industry as a process for manufacturing amorphous solid dispersions to improve the aqueous solubility and oral bioavailability. Spray Drying equipment is nowadays available in a broad variety of scales ranging from “micro” to commercial scale to cover the end-to-end development process of new active substances. In order to allow for a lean development, it is important that already at “micro” scale the material is representative for later commercial manufacturing so that limited or no reformulation work is necessary during scale up. This study will present case studies whereby scale up is shown from “micro” Spray Drying scale to commercial scale manufacturing.

Bio

Marianne Van Steenwinckel is an experienced Senior Scientist in Drug Product Development at Janssen R&D in Beerse, Belgium. Her expertise is in the area of oral solids development and especially in amorphous solid dispersions produced by enabling technologies particularly Spray Drying. She has worked on numerous development projects, where several has been commercialized, and she has extensive experience within Spray Drying with application of Design-of-Experiments, Scale-up through modeling, and implementation of Process Analytical Technologies. She holds a Master’s degree in Pharmaceutical Sciences and a Master’s degree in Industrial Pharmacy from the University of Gent.
Mark

Mark Saunders - P2C Pharma - UK

Title

The combined use of top-down particle processing and Spray Drying to engineer optimized drug particles 

Abstract

It is approximated that over 60 % of small molecule drugs in development possess poor water solubility characteristics, which can limit exposure after oral delivery. In recent years, Spray Drying has emerged as a leading enabling technology for production of amorphous solid solutions / dispersions via bottom up particle isolation, with the aim to improve the drug’s kinetic solubility and ultimately bioavailability. However, drugs may also possess certain other physicochemical and physico-mechanical properties that challenge development and alternative particle engineering technologies may be used to overcome these issues. This presentation highlights the combined use of a novel top-down wet-milling technology with spray drying to engineer and isolate drug particles with improved properties. Several case studies will be presented where this combined technology has been implemented to overcome specific hurdles, covering oral, pulmonary and nasal drug administration. 

Bio

Mark is currently working as a consultant to the pharmaceutical and biotech industries having spent nearly 20 years working in the contract research and development field. In his early career, Mark was involved in the commercial set up of a spin-out CRO from UCL (University College London), providing outsourced support for physicochemical properties testing of NCEs. The company quickly grew and Mark oversaw the implementation of both the solid-form screening and formulation groups, including the Phase I manufacturing for oral and inhaled drug products. After the business was acquired in 2007, Mark immediately went on to found Kuecept Ltd, an early-stage CRO specialising in designing bespoke preclinical and early-clinical formulations for drugs that exhibit complex bioavailability barriers. Since establishing the business in 2007, the company's technical expertise was globally recognised by over 100 leading pharma and biotech organisations and in 2016, Kuecept Ltd was acquired by Aptuit LLC. In addition to his commercial roles, Mark is also a member of the UK and US Controlled Release Societies, the UK Aerosol Society and Association of Pharmaceutical Scientists of Great Britain (APSGB), as well as serving as a member of the APS Materials Science Focus Committee. Mark has also been an author/collaborator on over 100 articles, book chapters and conference presentations and is also co-named on several patents on novel drug delivery technologies and particle engineering. In addition, Mark also co-edited 'The Essentials of Pharmaceutical Preformulation' book which was published by Wiley-Blackwell. in 2012.

Sune

Sune Klint Andersen - Janssen R&D - Belgium

Title

Spray Drying of Biopharmaceuticals 

Abstract 

Spray Drying is a well-known and accepted technology within the pharmaceutical industry for drying of small molecules both as drug substance, but also for drug product formulations e.g. amorphous solid dispersions. For biopharmaceutical formulations though, Spray Drying has only been used sparingly with freeze drying being the overwhelming choice as drying technology. However, over the last decade several developments within the pharmaceutical industry have taken place resulting in Spray Drying becoming a more accepted technology and more generally considered as a feasible technology for drying of biopharmaceuticals. In the presentation the challenges in Spray Drying of biopharmaceuticals will be discussed together with the possible solutions to overcome these.

Bio

Sune is currently a Principal Scientist in Spray Drying and Enabling Technologies at Janssen Research & Development, Belgium.  He has a Ph.D. in Chemical Engineering – Nanoparticle Technology and did an MBA in Management & Technology.  His main interests and professional experience include development of drying processes for biopharmaceuticals, small molecules, drug products, drug substances, and excipients for both R&D and industrial scale purposes. As well as application of Quality-by-Design in drying processes, validation and qualification of Spray Dryers, advantages & disadvantages of spray vs freeze drying processes, continuous manufacturing, mathematical modelling of drying processes, scale-up, aseptic spray drying, particle engineering, innovative drying processes and enabling technologies.  He has given several presentations on international courses and published articles on the above subjects. Sune is with Janssen since Apr-2017 and before that 10 years at Novo Nordisk (spray and freeze drying of peptides & proteins) and 8 years with GEA Niro A/S (Spray Drying, fluid bed drying, equipment design). 

Claudia

Claudia Mattern - MetP Pharma - Switzerland 

Title

Loading of mesoporous silica particles by Spray Drying for nasal formulations 

Abstract

The intranasal application impresses by its - outwardly simple appearing - drug delivery technology, ideally suited for enhanced delivery of centrally acting molecules to the brain. However, one the challenges is the low volume available for application. Therefore, multifunctional and safe excipients are required, such as mesoporous silicon dioxide.  The adsorption of steroid hormones by means of Spray Drying is shown as a technology that is mature and efficient.

Bio

Dr.rer.nat. Claudia Mattern has a broad background in pharmaceutical sciences, both in industry and in academia. She studied pharmacy at the Heinrich-Heine University Duesseldorf, received her PhD from the Humboldt University Berlin, and she is adj. professor at the Nova Southeastern University , Fort Lauderdale FL, USA. She is CSO at MetP Pharma AG (Emmetten, Switzerland), a pharmaceutical company specialized in nasal delivery of compounds via the systemic circulation and/or the nose-to-brain pathway.
Tomaso

Tomaso Guidi - Chiesi Farmaceutici - Italy

Title

Manufacturing and Characterization of inhalation products containing engineered particles produced by Spray Drying   

Abstract

The use of Spray Drying to manufacture inhalable aerosol particles with an aerodynamic particle size distribution within the range between 1 and 5 µm is well known and appreciated. Indeed, Spray Drying may offer advantages to obtain specific particle properties that facilitate their dispersion during inhalation, especially including excipients in the particle composition. Less known and explored is the use of this technique to manufacture particles able to act as carrier particles for Dry Powder Inhaler (DPI) products. Also in this case Spray Drying may be very helpful to design and tailor particle characteristics to have DPI products with customized properties. In the presentation some examples will be given along with their characterization.

Bio

Tomaso Guidi is Head of Section at Chiesi Farmaceutici SpA in the Product Development Department at Chiesi Farmaceutici SpA (Parma, Italy). His expertise is in the area of inhalation products and more specifically in the early phase of development. In 2003 he received his Master Degree in Pharmaceutical Chemistry and Technologies at the University of Bologna (Italy). After graduating he started working at GSK Italy (Verona) and Aptuit before joining Chiesi Farmaceutici in 2014.

Cedric

Cedric Van Holsbeke - FLUIDDA - Belgium

Title

In-vitro, in silico and in-vivo evaluation of Edry™, an innovative dry powder technology  

Abstract

In recent years, new dry powder inhaler (DPI) product development has focused on improved inhalation devices and more potent and patent protected new chemical entities. Despite these efforts, further therapeutic advancements could be made by improving delivery and efficiency of existing products. Particle engineering technologies, such as Spray Drying, present an opportunity for improved drug delivery to the lungs. Based on these considerations, a new formulation approach, Edry™, has been developed and patented. Edry is a formulation technology platform using Spray Drying which combines inhaled drugs with excipients such as lactose and leucine to engineer dry powder particles with optimal size and deagglomeration characteristics. In this presentation, the flow dependency of an Edry based budesonide (BUD) / formoterol fumarate (FF) combination will be described and compared to traditional particle technologies. Furthermore, the efficacy of the product will be evaluated both in-silico and in-vivo.

Bio 

Cedric Van Holsbeke received MSc degrees in both automation and biomedical engineering at Ghent University, Belgium. While holding the position as research engineer at FLUIDDA, he obtained a PhD in engineering science at the same university. His main interests is within continuous process optimization with a large focus on automated quality control. The work of his team has led to various publications in international peer-reviewed journals and has been awarded on multiple occasions. Since 2017 Cedric is Chief Technology Officer at FLUIDDA.



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