International SPRAY DRYING know-how & hands-on seminar

Thu, 30 May 2013 - 08:30 to Fri, 31 May 2013 - 16:30
Experts from Universities and Industry, daily active in the field of Spray Drying in Bio Pharma from R&D to Production, exchange their know-how and hands-on experiences with you!

Program

Day 1

  • 8 Experts lecture about Bio Pharma SPRAY DRYING applications. Topics : Formulation, Scale-up, Amorphous Solid Dispersions, Bio molecules, Injectables, Pulmonary delivery, Drying thermodynamics, Preclinical Development, Commercial scale, Pulmonary delivery, ………
  • Evening program: walking dinner through historical centre of Gent

Day 2

  • Participants are split in small groups and are exposed to different hands-on exercises on Spray Drying equipment in Particle sizing, Solid Dispersions, Spray Drying under Nitrogen conditions, Spray Congealing, Glass Transition problems, Mollier Diagram, Heat & Mass balances, ….
  • Important: places are limited for optimal participation exposure

Practical

Participation Fee

  • Day 1: 950 Euro
  • Day 1+2: 2.100 Euro
  • Novotel  Hotel: 121,5 Euro per night including breakfast

Location

  • Day 1: Novotel, Goudenleeuwplein 5, 9000 Gent
  • Day 2: ProCepT, Industriepark Rosteyne 4, 9060 Zelzate

 

ProCepT


Agenda

Day 1

08.30  Registration and Welcome
09.00 Spray Drying process technology, an instant Drying Process to engineer a particle (by Filip Van der Gucht – ProCepT Belgium)
09.40 Amorphous solid dispersions: manufacturing, physical chemistry, analysis and performance (by Guy Van den Mooter – University of Leuven Belgium)
10.20 Coffee Break
10.30 Spray Drying formulation, process development and scale-up from mg to kg of a low bioavailability compound for preclinical in vivo study (by Sebastian Ullrich – Grünenthal Germany)
11.10 Spray Drying formulation and process optimization of sensitive Bio molecules on lab scale (by Geoffrey Lee – University Erlangen Germany)
12.00 Lunch
13.20 Scaling up of the spray drying process from micro to commercial scale manufacturing (by Geert Verreck – Janssen R&D Belgium)
14.00 Spray Drying of long-acting injectable formulations for poorly soluble anti-HIV compounds (by Joke Meeus – University of Leuven Belgium)
14.40 Coffee Break
14.50 Spray Drying for Pulmonary Delivery (by Nikki Whitfield – Quotient Clinical UK)
15.30 Drying thermodynamics, fundamentals required for optimal Spray Drying process understanding, scale-up and design (by Rudy Visbeek – mrf Inco Spain)
16.10 Open Forum
16.30 End
19.00 Walking dinner through historical Medieval city of Gent

Day 2

08:00 Hotel pick-up
08:30 Welcome in ProCepT Zelzate
09:00 Spray Drying Hands-on Part 1
10:15 Spray Drying Hands-on Part 2
11:30 Coffee Break
11:45 Spray Drying Hands-on Part 3
13:00 Lunch
13.45 Spray Drying Hands-on Part 4
15:00 Spray Drying Hands-on Part 5
16:15 Reception
17:00 Return to Ghent or Zaventem-Brussels Airport

Hands-on Exercises:

  1. Mollier Calculations
  2. RH and Droplet Size in Spray Dryer with Nitrogen Closed Loop system
  3. L.O.D & Solid State by Spray Drying
  4. Particle Sizing & Shaping by Spray Drying
  5. Solid Dispersion & Glass Transition by Spray Drying

Speakers biography

Filip Van der Gucht (ProCepT - Belgium) 

Title
Spray Drying process technology, an instant Drying 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 or function.  This lecture introduces the Spray Drying / Congealing 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 Business Development Director at 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

Guy Van den Mooter

Prof Guy Van den Mooter (University of Leuven - Belgium)     

Title
Amorphous solid dispersions: manufacturing, physical chemistry, analysis and performance

Abstract
The use of amorphous solid dispersions is an interesting strategy to increase the bioavailability of poorly soluble drugs by improving their rate and extent of dissolution. Lack of understanding of the physical chemistry and their in vivo behavior still hamper full breakthrough in pharmaceutical industry. This paper aims to review aspects like the amorphous state, manufacturing, characterization and biopharmaceutical testing to better understand the strength and weakness of this formulation strategy.

Bio
Prof. Guy Van den Mooter studied pharmacy and industrial pharmacy at the KU Leuven and received his PhD from the same university in 1994. He worked as scientist in the department of pharmaceutical development at Janssen Pharmaceutica (Belgium) until 1996. From 1997 until 1999 he was a post-doctoral researcher in the laboratory for Pharmacotechnology and Biopharmacy (KU Leuven). In 1999 he was appointed assistant-professor and in 2009 full professor at the KU Leuven. His main research interests are the physical chemistry of solid dispersions, formulation strategies for poorly soluble drugs like solid dispersions, nanoparticles, and mesoporous silica, polymorphism of drugs and thermal analysis. He teaches courses of pharmaceutical technology and physical chemistry of drugs in undergraduate and graduate programs. He is the coordinator of the master program in industrial pharmacy. So far, he has (co)authored more than 180 peer reviewed papers. In 2007, he founded FORMAC Pharmaceuticals N.V., a drug delivery and development company

Sebastian Ulrich

Sebastian Ullrich (Grünenthal - Germany) 

Title
Spray Drying formulation, process development and scale-up from mg to kg of a low bioavailability compound for preclinical in vivo study

Abstract
In order to increase the bioavailability in preclinical in-vivo studies an amorphous solid dispersion was developed.  Starting with a few milligram of active material the most suitable polymer was chosen. Afterwards the process parameters were optimized stepwise to identify the optimal formulation and to achieve a robust process. In further steps the process parameters were adapted to gain maximal spray drying throughput in order to supply formulations to preclinical in-vivo studies.

Bio
Sebastian Ullrich studied pharmacy at the Philipps-University of Marburg (Germany). He received his PhD from the Martin-Luther University of Halle (Germany) in 2008. He has been working for Grünenthal (Aachen, Germany) since 2008. His responsibility is to develop and manufacture formulations for preclinical studies.

Geoffrey Lee

Prof Geoffrey Lee (Erlangen University - Germany) 

Title
Spray Drying formulation and process optimization of sensitive Bio molecules on lab scale

Abstract
This presentation reviews the spray drying of biomolecules, especially peptides and proteins, on the laboratory scale in pharma.  The effects of process conditions on product quality is discussed, especially the potential for damage to sensitive biomolecules during atomization and droplet drying.  Formulation aspects will also be considered as a technique to stabilize the actives during the spray drying process. By using levitated single-droplet drying studies it is possible to predict to some extent the behaviour in a spray dryer.

Bio
Geoff 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.   

Geert Verreck

Geert Verreck (Janssen R&D - 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
Geert Verreck is a Scientific Director and Fellow in Drug Product Development at Janssen R&D in Beerse, Belgium. His expertise is in the area of oral solid development and more specifically in amorphous solid dispersions. He started working for J&J in 1995 after graduating as a chemical engineer. In 2005 he received his Ph.D. in Pharmaceutical Sciences at the Catholic University of Leuven, Belgium. He has published 32 papers as author or co-author and holds 8 patents in the area of solid dispersions.

Joke Meeus

Joke Meeus (University of Leuven - Belgium) 

Title
Spray drying of long-acting injectable formulations for poorly soluble anti-HIV compounds

Abstract
We aim to spray dry polymeric microspheres for intramuscular injection as a controlled release formulation for the treatment of HIV. The influence of process and formulation parameters on the particle characteristics is elucidated along with the release behaviour of the resulting formulations.

Bio
Joke obtained her Master’s degree in Pharmaceutical Sciences from the University of Brussels. She is currently enrolled in the PhD program at the University of Leuven, in the laboratory of Drug Delivery and Disposition. Joke is working on the development of long-acting injectable formulations for poorly soluble ant-HIV compounds. Her research expertise includes spray drying of solid dispersions, thermal analysis, surface analysis and in vitro release studies.

Nikki Whitfield

Nikki Whitfield (Quotient Clinical - UK) 

Title
Spray Drying for Pulmonary Delivery

Abstract
Over the last few decades, spray drying has become a key technique for those working in the field of pulmonary drug delivery. Efficient and effective delivery of compounds is supported by the use of a technique which can engineer particles with the desired characteristics to ensure accurate delivery to the target area of the lung. With a growing interest in the application of Quality by Design, the Critical Quality Attributes (CQA’s) of formulations intended for pulmonary drug delivery include particle size, shape, density and aerodynamic properties; all of these properties can be manipulated and controlled via a spray drying process. Interest in the delivery of more complex biological and large molecules to the lung often leads the developer to spray drying as the processing technique of choice given the ability to intimately mix stabilising or modifying excipients into the spray dried particle; the combination of excipient selection and processing parameters allows the engineering of a formulation with enhanced stability and aerosol properties which is difficult to achieve with traditional micronisation and blending techniques. The delivery of proteins to the lung is particularly problematic when using traditional techniques due the interaction of the protein with sugar carriers such as lactose; spray drying of the drug alone or in combination with excipients is often used to overcome this issue. The presentation will focus on the spray dryer processing parameters important during spray drying of formulations intended for pulmonary drug delivery and how these affect the CQAs of the final product.

Bio
Nikki Whitfield joined Quotient Clinical in February 2012 as Senior Director, Pharmaceutical Operations and is responsible for the operational delivery of the formulation development, pharmaceutical analysis and GMP manufacturing groups.  She possesses 19 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

Rudy Visbeek

Rudy Visbeek (mrf Inco - Spain) 

Title
Drying thermodynamics, fundamentals required for optimal Spray Drying process understanding, scale-up and design.

Abstract
The Drying fundaments are explained in a theoretical and pragmatic way.  It is important that people involved in Spray Drying processes have a good understanding of the drying thermodynamics and its influences on the process design and final powder characteristics.

Bio
Rudy Visbeek is a Director at mrf Inco, a Spanish subsidiary of ProCepT offering process and engineering services. Besides his know-how in mechanics and automation he has built up expertise in Thermodynamics of the ProCepT drying technologies: vacuum, microwaves, fluid bed, coating, spray drying. Rudy is involved in several consulting projects to optimize production drying processes. Rudy has a Master in Electro Mechanical Engineering.

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