Spray Drying in life sciences

Thu, 27 Oct 2016 - 08:30 to Fri, 28 Oct 2016 - 16:30
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

  • 10 Experts lecture about Spray Drying applied in life sciences. Topics: Particle Engineering, Amorphous Solid Dispersions, API & Biologicals, Scale-up, Pulmonary delivery, Analytical Methods, Early & Clinical Development, Commercial scale, Quality by Design, PAT, Modelling, Continuous processing, ...
  • Evening program: walking dinner through historical centre of Gent

Day 2: Hands-on workshop

  • 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, ... 

Important: places are limited for optimal participation exposure!

gent

Practical

Participation Fee

  • Day 1: 950 euro pp
  • Day 1 + 2: 2.100 euro pp
  • Gent Mariott Hotel: 144 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 by ProCepT
09:00 Spray Drying an instant process to engineer a particle (Filip Van der Gucht - ProCepT - Belgium)
09:40 Spray Drying as process technology to obtain amorphous solid dispersions (Lieselotte De Smet - Xedev - Belgium)
10:20 Coffee break
10:35 Scaling up of the Spray Drying process from micro to commercial scale manufacturing (Marianne Van Steenwinckel - Janssen Pharma - Belgium)
11:15 Spray Drying of Biologics and product analysis in R&D (Geoffrey Lee - University Erlangen - Germany)
12:00 Lunch
13:00 Spray Drying of Biologicals from lab to production scale (Sune Klint Andersen - Novo Nordisk - Denmark)
13:40

Combining targeted experiments with advanced process modelling approaches for developing Spray Drying operations (David Slade - PSE Formulated Products - UK)

14:20 Use of Spray Drying for the formulation of poorly suluble molecules to support early clinical evaluation in healthy volunteers (Nikki Whitfield - Quotient Clinical - UK)
15:00 Coffee break
15:15 Spray Drying and Characterization of particles for inhalation (Anne Haaije de Boer - University of Groningen - The Netherlands)
15:55 Continuous improvement and the use of PAT in commercial scale Spray Drying (Dylan Jones & Nick Hodgson - Sanofi - UK)
16:35 Open Forum
17:00 End of Lectures
19:00 Walking dinner through historical Medieval city of Gent

Day 2

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

Spray Drying an instant process to engineer a particle

Abstract

Spray Drying has found its way into Pharma and Biotec applications thanks to the speed of drying and the capabilities to engineer a particle to size, shape and function. This lecture introduces the Spray Drying process technology and capabilities in particle engineering supported by practical examples.

Bio

Filip Van der Gucht has a Master in Chemical Engineering BioTechnology and is CEO from ProCepT. Filip has built up 20 years hands-on process knowhow in drying, agglomeration, mixing and coating technologies. He is involved in several contract development and scale-up projects for third parties. Filip focuses on Spray Drying/Congealing and he has processed more than 200 compounds and supervised several Master proofs and posters in this area.

Lieselotte De Smet - Xedev - Belgium

Title

Spray Drying as process technology to obtain amorphous solid dispersions

Abstract

80% of the new chemical entities are classified as poorly soluble drugs and need formulation in order to improve the solubility and bioavailability. One of the main techniques to obtain amorphous solid dispersions is Spray Drying. This technique is well integrated in the pharma-industry over the last few years. This presentation shows the use of Spray Drying in the early development of pharmaceutical formulations together with aspects as the solid state, characterization and biopharmaceutical testing.

Bio

Lieselotte De Smet studied pharmacy at Gent University and received here PhD from the same university in 2013. After a short period as post-doctoral researcher she started in 2014 in Xedev as project manager where she mainly works on formulation projects for third parties in the field of drying, coating and agglomeration.

Marianne

Marianne Van Steenwinckel - Janssen Pharma - Belgium

Title

Scaling up of the Spray Drying process from micro to commercial scale manufacturing

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 two case studies whereby scale up is shown from “micro” spray drying scale to commercial scale manufacturing.

Bio

Marianne Van Steenwinckel is a Senior Scientist in Drug Product Development at Janssen R&D in Beerse, Belgium. Her expertise is in the area of oral solid development and more specifically in amorphous solid dispersions produced by enabling technologies. In 2005 she received her master degree in Pharmaceutical Sciences at the University of Gent, Belgium and in 2006 she received her master in Industrial Pharmacy. After graduating she started working in 2007 as a pharmacist and in 2008 she joined J&J.

Geoffrey

Geoffrey Lee - University Erlangen - Germany

Title

Spray Drying biologics and product analysis in R&D

Abstract

Selecting the right techniques for analysing the quality of a spray dried product is an integral part of any development exercise and this is particularly the case with biologicals. The structural and activity attributes of a biological that can be damaged during spray drying will be discussed. The analytical techniques that are available for their assessment and quantification in an R & D setting will then be presented. The necessity of using a battery of techniques for a biological will be elucidated.

Bio

Geoffrey Lee studied pharmacy in London and subsequently took his PhD at Chelsea College in the area of colloid science. His post-doc time was spent in the US at the Universities of Southern California Los Angeles and North Carolina at Chapel Hill. After 2 further years as an assistant professor at Illinois University in Chicago he moved to Heidelberg University in 1986 where he was involved in extensive research activities into the barrier properties of human skin. Since taking over the chair of pharmaceutics at Erlangen University his major research interest has  been the peparation of stable protein formulations using spray drying, spray-freeze drying, and freeze drying.
Sune

Sune Klint Andersen - Novo Nordisk - Denmark

Title

Spray Drying of Biologicals from lab to production scale

Abstract

Spray Drying has over the last decades become generally recognized in the pharmaceutical industry as a viable alternative to freeze drying for drying of biologicals for pharmaceutical use. The rise of Quality-by-Design and lean development has meant an increased
focus on early stage spray dried material being representative for production scale material in order to facilitate scale-up.
 In the presentation case studies will be presented illustrating spray drying of biologicals including scale-up and scale-down use of Spray 
Drying.

Bio

Sune Klint Andersen is a Principal Scientist in Drying processes at Novo Nordisk, Denmark working with pharmaceutical Spray Drying and
freeze drying of biological molecules. Before joining Novo Nordisk in 2007, he worked at GEA Niro with pharmaceutical Spray Drying processes and Spray Dryer designs. His expertise is within the area of development of drying processes for parenteral and solid dosage
forms and the application of Quality-by-Design in spray drying processes. He has given numerous presentations in the area of Spray Drying and the application of Quality-by-Design.

David

David Slade - PSE Formulated Products - UK

Title

Combining targeted experiments with advanced process modelling approaches for developing Spray Drying operations

Abstract 

Spray Drying is widely used to create powders with a broad scope of application such as detergents, food powders and pharmaceuticals. Combining mechanistic models with targeted experiments enables efficient development of robust spray drying processes. Often modelling and experimental approaches are performed in isolation, however a targeted approach using both fields can be more efficient and beneficial. The workflow needed to utilise such a combined approach and the benefits of this approach will be explored. Further to this, a number of levels of fidelity of Spray Drying models are now accessible and the measured use of each should be part of the development workflow. Demonstrative examples and selected case studies of different uses of an targeted experiment and modelling approach provide illustration of the power of selecting such a method.

Bio

Dr David Slade is a Senior Consultant in PSE’s Formulated Products team. His main role is as lead develop of PSE’s gSOLIDS model library which provides integrated modelling of solid-based processes such as wet granulation, milling and roller compaction. David’s main area of interest is in drying unit operations with a particular emphasis on the enhancement of spray drying model-based approaches. Prior to joining PSE, he completed his PhD in the Mechanical Engineering department at the University of Leeds. During his final year at Leeds, he worked in the University of Leeds-P&G simulation centre on Spray Dryer modelling of counter-current towers. Since joining PSE he continues to work closely with a number of large pharmaceutical, consumer good and food companies providing consultancy and support in the application of advanced process modelling approaches to R&D and manufacturing process development.

Nikki

Nikki Whitfield - Quotient Clinical - UK

Title

Use of Spray Drying for the formulation of poorly soluble molecules to support early clinical evaluation in healthy volunteers 

Abstract

With the increasing number of poorly soluble drug molecules in early development and the increase in the number of novel formulations being developed for the inhaled route of administration, there is a growing interest in using more innovative formulation technologies to generate prototypes for evaluation in early clinical phase studies. Quotient Clinical uses a variety of formulation strategies including spray drying to generate drug product prototypes which are subsequently clinically evaluated using its novel Translational Pharmaceutics approach to obtain real time clinical data to direct drug product development. The presentation will outline the use of Spray Drying to achieve the target product profile of new molecules and their subsequent evaluation in healthy volunteer clinical studies using the Quotient Clinical Translation Pharmaceutics 

Bio

Nikki Whitfield joined Quotient Clinical in February 2012 as Vice President, Pharmaceutical Sciences and is responsible for the operational delivery of the formulation development, pharmaceutical analysis and GMP manufacturing groups.  She possesses 23 years’ experience in the Pharmaceutical Industry and has previously held technical leadership positions in Quadrant Healthcare, Quadrant Drug Delivery and Elan where she was 
responsible for the development, transfer and scale up of both early phase and late phase inhaled and topical products intended for both European and US markets. In her previous position as a Project Director at Vectura, she led the early phase product development for two inhaled, orphan indication products and the late stage development for a novel sterile topical product. Nikki holds a Bachelor of Science degree from the University of Nottingham.
Anne Haaije

Anne Haaije de Boer - University of Groningen - The Netherlands

Title

Spray Drying and Characterization of particles for inhalation   

Abstract

Inhaled aerosol particles need to have an aerodynamic particle size distribution within the very narrow range between 1 and 5 micron. This size distribution can be obtained with different techniques, but Spray Drying may offer advantages to obtain specific particle properties that facilitate their dispersion during inhalation. Such properties include particle shape and density as well as their surface structure depending on the type of inhaler used. Spray Drying also enables efficient co-processing of drugs, or drugs and the excipients used to achieve the desired particle properties. After preparation, appropriate characterisation is needed and for development of dry powder inhalation systems, laser diffraction technique is a fast, accurate and reliable tool. It enables to study the dispersion efficiency of the formulation-inhaler combination with the primary particle size distribution of the drug as reference.

Bio

Anne Haaije de Boer is a process engineer who started his career at the University of Groningen (RUG) for the Department of Pharmaceutical Technology and Biopharmacy in 1973. In 1990 he initiated the inhalation group of the department, which focuses on understanding the mechanisms of particle-particle interaction in dry powder formulations for inhalation, the development of new techniques for aerosol characterisation and dry powder inhaler (DPI) concept design and development. His group developed the basic concepts for the marketed Novolizer (Meda) and Genuair (AstraZeneca) DPIs for delivery of anti asthma and COPD drugs and the (disposable) Twincer and Cyclops DPIs (PureIMS) for the delivery of high dose drugs like colistimethate sodium (CF) and levodopa (Parkinson’s disease). AH de Boer retired in 2015 as leader of the inhalation group, but renewed his contract with the university as advisor for another ten years.

Dylan

Nick

Dylan Jones & Nick Hodgson - Sanofi - UK

Title

Continuous improvement and the use of PAT in commercial scale Spray Drying 

Abstract

Spray Drying has been used at the Sanofi site in Haverhill for drying a polymeric API for 15 years. This lecture tells the story from the early days of commissioning the process through to the present day where the throughput and run times are being pushed beyond the original design intent. This has been enabled by the use of Process Analytical Technology (PAT) which has been crucial to the success of the fully continuous process employed at the site.

Bio Dylan Jones

With over 20 years’ experience in the pharmaceutical industry, Dylan Jones currently holds the position of Head of Analytical Chemistry at Sanofi, Haverhill.  Within his group is the Centre of Excellence in Process Analytics, providing PAT services locally and for the wider organisation.  Activities cover continuous manufacturing of APIs, biotechnology, and biologics. His group actively pursues innovation in advanced manufacturing and control.

Bio Nick Hodgson

Nick Hodgson has a Masters in Chemical Engineering from the University of Sheffield and is the Head of Engineering at the Haverhill site for Sanofi. Nick joined the company in 2001 as the first Spray Dryers were being installed for a large scale API process and has worked with the technology since that time in a variety of engineering and operational roles.



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