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Pharma

Freeze-Drying Technology Summit

  • 13th – 14th February 2020
  • Austria flag Austria Vienna
  • Hilton Garden Inn Vienna South Hertha-Firnberg-Straße 5, 1100

This event provides the appropriate platform for industry leaders to discuss process innovation and technical aspects in lyophilisation for the pharmaceutical industry, as well as food and cosmetics manufacturers, regulatory agencies and academia. 

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About

The summit will be focussed on practical considerations for freeze-dried formulation development, process optimisation, validation and control. We will discuss the advancing concepts and regulatory considerations for lyophilised biologics, spray-drying of biologics, vaccines, new-wave of cosmetic ingredients and highly potent products.

Who Should Attend

Chief Executives, Directors, Vice Presidents, Department Heads, Leaders, Managers, Scientists and Technologists specialising in:  

  • Lyophilisation
  • Parenterals 
  • Vaccines 
  • Pre-Filled Syringes 
  • Bioprocess   
  • Characterisation  
  • Container Development   
  • CMC 
  • Drug Development   
  • Engineering   
  • Freeze-Drying   
  • Formulation   
  • Licensing   
  • Packaging & Labelling   
  • Process Technology 
  • Process Monitoring & Control   
  • Process Analytics 
  • Product Innovation 
  • QA/QC 
  • Risk Management   
  • Regulatory Affairs   
  • Research & Development   
  • Stability 
  • Standardisation   
  • Sterilisation   
  • Validation  
  • Cell Manufacturing   
  • Quality Assurance   
  • Plant Management   
  • Food Processing 
  • Freeze-Dried Foods
  • Expedition/Emergency Food
  • Cosmetics Manufacturing

Key Practical Learning Points

  • Current regulatory considerations
  • Novel concepts of freeze-drying
  • Process optimisation, monitoring and control
  • Innovations in formulation development
  • QbD and PAT approaches
  • Strategies for scaleup from R&D scale to full production level
  • Technologies overview and advantages in manufacturing
  • What is the new role of sterile and lyophilised products manufacturing in the future
  • Spray-drying applications
  • Freeze-drying for food industry

Dr. Stefan Schneid, DE

Laboratory Head of Development Parenterals

Bayer

About Speaker

Prof. Geoff Smith, UK

Professor of Pharmaceutical Process Analytical Technology

De Montfort University

About Speaker

Dr. Mostafa Nakach, FR

Head of Formulation & Process Development / Biologics Drug Product Development

Sanofi

About Speaker

Dr. Andrea Weiland-Waibel, DE

Managing Director

Explicat Pharma GmbH

About Speaker

Franz Bosshammer, DE

Global Technology Partner

Pharmaplan GmbH

About Speaker

Bert Van Meervenne, BE

Senior Manager Aseptic Process Development

Pfizer

About Speaker

Filip Dorozinski, AT

Senior Manufacturing Scientist

Takeda

About Speaker

Dr. Maja Anko, SI

Senior scientist in Drug Product Development

Novartis

About Speaker

Prof. Davide Fissore, IT

Advanced Process Control, Process Design, and Food Processes & Technologies

Politecnico di Torino

About Speaker

João Henriques, PT

Team Leader – R&D Drug Product Development

Hovione

About Speaker

Bernadette Morel, NL

Scientist, Bioprocess Development & Application

DSM Biotechnology Centre

About Speaker

Dr. Paul Matejtschuk, UK

Principal Scientist & Section Head, Standardization Science / Analytical & Biological Sciences Division

NIBSC

About Speaker

Dr. Audrey Maudhuit, FR

European Process Engineer

Fluid Air

About Speaker

Xulei Wu, US

Senior Food Scientist

Space Food Systems Laboratory / Human Health and Performance Contract / MEI Technologies | NASA

About Speaker

Carlo Marconi, IT

General Manager BU Inspection Machines

Antares Vision

About Speaker

Dr. Stefan Schneid, DE

Laboratory Head of Development Parenterals

Bayer

Dr. Stefan Schneid is currently a laboratory head in the formulation development department at Bayer AG. In this function, he develops formulations and processes for novel biological entities and small molecules, and is involved in development projects from pre- clinical stage up to transfer to commercial production. Previously, Stefan worked as R&D manager at Syntacoll GmbH in Saal, Germany, where he was responsible for the development of novel formulations and analytical methods for drug-containing biodegradable implants for parenteral application. Until 2010, he was a post-doctoral research fellow in the freeze-drying focus group at the University of Erlangen, and spent one year as a visiting scientist in Prof. Michael Pikal’s lab at the University of Connecticut. Stefan holds a degree of pharmacy from the University of Munich, and received his PhD in pharmaceutics from the University of Erlangen in 2009 for his dissertation thesis titled “Investigation of Novel Process Analytical Technology (PAT) Tools for Use in Freeze-Drying Processes”. He developed and optimised the formulation and manufacturing process of various predominantly lyophilised pharmaceuticals including proteins, peptides, vaccines and small molecules.

Prof. Geoff Smith, UK

Professor of Pharmaceutical Process Analytical Technology

De Montfort University

Geoff Smith is a Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). His research group focusses on pharmaceutical applications for impedance, dielectric and terahertz spectroscopies alongside optical techniques such as laser speckle and optical flow. He is responsible for the development of through vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), ice interface temperatures, primary drying rates and end points. More recently, and in collaboration with Biopharma, he developed Z-FDM - a freeze-drying microscope with an integrated impedance spectrometer, for the objective assessment of the collapse temperature and for the determination of ice nucleation temperatures, solidification times, and drying rates. Prof. Smith’s presentation will focus on both the TVIS and Z-FDM technologies with the view to demonstrating how a one physical measurement (impedance spectroscopy) might be used across all scales of the product and process development cycle.

Dr. Mostafa Nakach, FR

Head of Formulation & Process Development / Biologics Drug Product Development

Sanofi

Dr. Mostafa Nakach is a PhD from Toulouse University. He has prepared his thesis on stabilisation and production of nanocrystalline suspension. He is also а Master II graduate from Paris-Sud University in pharmacotechnie and biopharmacy, and a pharmaceutical engineer from École des mines d’Albi. Mostafa has been working within Sanofi Group for 32 years. His current position is a head of formulation and process development section within biologics drug product development. His mission is to build and to manage the required skills and capabilities in order to support R&D projects development mainly for fill and finish commercial process development of biotech products, including freeze-drying.

Dr. Andrea Weiland-Waibel, DE

Managing Director

Explicat Pharma GmbH

Dr. Andrea Weiland-Waibel is a managing director of Explicat® Pharma GmbH, a privately- owned company, providing technical project management services and pharmaceutical development services to the pharmaceutical industry (CMC). Andrea is a pharmacist with a PhD in pharmaceutical technology on biodegradable microspheres and cyclodextrins (Ludwig Maximilian University, Munich). She held several leading roles within Pfizer, working as project manager in process technology and being responsible for technology transfer and process development, mainly on sustained release solid dosage forms. Within R&D she was a responsible scientist for pharmaceutical development (Phase I - III, candidate characterisation, and lyophilisation projects). After joining IDEA AG, a biotechnology company based in Munich, Andrea held the position of director of pharmaceutical development and was responsible for process technology development, drug delivery system development (liposomes, patches), formulation of recombinant proteins, analytical development and clinical supplies manufacturing. She also served as IDEA`s QP and is the founder of Explicat Pharma GmbH and has been the managing director since 2005. She and her team`s experience cover the development of biopharmaceuticals (e.g. recombinant factor VIII), development of lyoformulations and lyocycles, analytical development, related QA and regulatory issues. Explicat Pharma has been assigned several projects, involving the modern process validation approach, including lyocycle robustness testing. Andrea is a qualified individual and a member of AAPS and several other professional institutions, based in Europe, including APV, DphG, Bay, LAK and A3P.

Franz Bosshammer, DE

Global Technology Partner

Pharmaplan GmbH

Franz Bosshammer has a degree in mechanical engineering, as well as an MBA. Prior to joining NNE Pharmaplan in October 2012, Franz has filled various positions, such as process engineer and sales director in the supplying industry for pharmaceutical, aseptic fill and finish machines. His latest employment was as a general manager at Optima Group Pharma. He started his career in the field of process engineering in 1986. Franz has more than 30 years of experience in development and manufacturing of machines for aseptic pharmaceutical operations, with a special focus on freeze-drying technology. Franz has been engaged in various international fill and finish projects over the course of his career.

Bert Van Meervenne, BE

Senior Manager Aseptic Process Development

Pfizer

Bert Van Meervenne graduated in 1989 as a chemical engineer with a focus on processing techniques. He joined Pfizer (Upjohn at that time) in 1991 and worked in aseptic production until 2017, covering batch formulation, autoclaving, stopper processing, filling and visual inspection, but for the larger part of this period (20-plus years) the main focus was on commercial lyophilisation. In his years as a supervisor, Bert was also the production representative in several projects, including a highly automated formulation area, a new stopper sterilisation centre and installation of a number of new lyophilisers. Since 2017, Bert has been working on lyophilisation in Pfizer global technology and engineering, mostly involved in product transfers and problem solving.

Filip Dorozinski, AT

Senior Manufacturing Scientist

Takeda

Filip Dorozinski has a BSc in technical chemistry from TU Vienna and 13 years of experience in the pharmaceutical industry (Baxter, Baxalta, Shire, Takeda). He has held several roles in manufacturing, and is since early 2018 he has been a manufacturing scientist with a focus on formulation, fill and finishing.

Dr. Maja Anko, SI

Senior scientist in Drug Product Development

Novartis

Dr. Maja Anko is currently working as Senior Scientist in Technical Research and Development (TRD) Novartis. She is supporting new biological entities projects as well as biosimilar projects covering the whole formulation and process development including Tech transfer. She is an expert in lyo cylce development and transfer using cutting-edge technology and modelling approach. Maja Anko obtained Master’s degree in the field of Molecular biology in Biotechnical Faculty, University of Ljubljana and made her PhD and post doctoral training in Biochemistry and Molecular biology in Faculty of Medicine, University of Ljubljana. During her academic career she focused in the fields of of biochemistry, cell biology and biophysics on working with RNA/cDNA, proteins and lipid membranes or scientist in Drug product development.

Prof. Davide Fissore, IT

Advanced Process Control, Process Design, and Food Processes & Technologies

Politecnico di Torino

Prof. Davide Fissore is a professor of process control and food processing technologies at Politecnico di Torino (Italy), where he is the leader of the process system engineering group. In the field of the freeze-drying of pharmaceuticals products, Davide’s research activity is focussed on the use of mathematical models to optimise in-line (using a control system) and off-line (using the design space of the product) the operating conditions for a given product, and on the design of tools combining mathematical models and process measurements to monitor in-line both the primary and secondary drying steps of the process. Davide acted as principal investigator in several research projects granted by pharmaceutical companies focussed on the design/optimisation/scale-up of batch freeze- drying processes.

João Henriques, PT

Team Leader – R&D Drug Product Development

Hovione

João Henriques is a biological engineer by training. He specialised in process monitoring and control for pharma and biopharma processes, having trained in Bayer and Merck KGaA and worked in Roche as a consultant before joining Hovione in 2008 as a PAT specialist. João has worked in the manufacturing systems efficiency group and later as a formulation and process development scientist since 2013. He has supported development and validation of spray-drying, jet-milling, roller compaction and tableting projects. João is currently the team leader for the formulation group at Hovione’s drug product development.

 

Bernadette Morel, NL

Scientist, Bioprocess Development & Application

DSM Biotechnology Centre

Bernadette Morel (MSc) is a food scientist from Wageningen University focussed on industrial microbiology. Bernadette filled various positions such as biotechnology process development engineer and a major producer of flavours, fragrances and food ingredients; process engineer at a pharmaceutical company developing formulations and freeze-drying process up to pre-clinical trials. Since 2012, Bernadette has been a scientist at DSM, developing innovative savoury products applying enzyme technology and spray-drying, and freeze-dried culture products for food applications. She has designed, optimised and transferred processes successfully into full-scale manufacturing sites all over the world.

Dr. Paul Matejtschuk, UK

Principal Scientist & Section Head, Standardization Science / Analytical & Biological Sciences Division

NIBSC

Dr. Paul Matejtschuk leads a formulation and freeze-drying team at NIBSC focussed on delivering lyo solutions for biological reference materials, many of them WHO international reference preparations (joined NIBSC in 2001). He has over 30 years’ postdoctoral experience in downstream processing and analysis of biologics, and has co-authored over 40 peer-reviewed papers and co-supervised several PhD students with Prof. Paul Dalby (UCL, London). Paul is one of a number of directors of the International Society for Lyophilisation Freeze Drying, a not-for-profit society whose aim is to enhance global understanding and uptake of best lyophilisation practices. Co-edited (2019) with Dr. Kevin Ward (Biopharma Technology Ltd, UK) a recent volume on “Lyophilization of Pharmaceuticals & Biopharmaceuticals“ for Springer in the “Methods in Pharmacology & Toxicology” series.

Dr. Audrey Maudhuit, FR

European Process Engineer

Fluid Air

Dr. Audrey Maudhuit is the process engineer at Fluid Air, a division of Spraying Systems Co®. She has a PhD in process development, specialising in microencapsulation. She graduated from the French engineering school Ecole des Mines. She has developed both R&D and commercial processes for the production of food and feed, as well as managed production teams.

Xulei Wu, US

Senior Food Scientist

Space Food Systems Laboratory / Human Health and Performance Contract / MEI Technologies | NASA

Xulei Wu serves as a MEIT senior food scientist in the space food systems laboratory at NASA Johnson Space Center. In this role, she leads the freeze-drying production to support human space exploration, conducts R&D work to optimise freeze-drying cycle, and guarantee the safety, nutrition and palatability of the space food. She recruits and trains R&D sensory panel to support freeze-drying cycle optimisation and shelf-life study. Prior to joining MEIT/NASA in 2018, she was with Oregon Freeze Dry in various QA and R&D roles. Her specialty is in freeze-drying technology, low moisture food, sensory evaluation and shelf-life study. She earned a bachelor’s in food science and engineering from Shanghai Jiao Tong University, and a master’s in food science and technology from Oregon State University.

Carlo Marconi, IT

General Manager BU Inspection Machines

Antares Vision

After studying electrical engineering at the University of Padua (Italy), Carlo Marconi began his professional career in 1982 in a pharmaceutical company for automated visual inspection in R&D and electronic design, where he was also responsible for the electronic design of HVLD for CCIT. He has also developed his skills and has taken on responsibilities in project management and sales management for industrial automation systems and later for a manufacturer of automated visual inspection and leak detection systems in the pharmaceutical industry. Since 2017, Carlo has been managing director of BU Inspection Machines at Antares Vision, the leading company for track and trace and inspection machines in the pharmaceutical industry.

Dr. Stefan Schneid, DE

Laboratory Head of Development Parenterals

Bayer

Prof. Geoff Smith, UK

Professor of Pharmaceutical Process Analytical Technology

De Montfort University

Dr. Mostafa Nakach, FR

Head of Formulation & Process Development / Biologics Drug Product Development

Sanofi

Dr. Andrea Weiland-Waibel, DE

Managing Director

Explicat Pharma GmbH

Franz Bosshammer, DE

Global Technology Partner

Pharmaplan GmbH

Bert Van Meervenne, BE

Senior Manager Aseptic Process Development

Pfizer

Filip Dorozinski, AT

Senior Manufacturing Scientist

Takeda

Dr. Maja Anko, SI

Senior scientist in Drug Product Development

Novartis

Prof. Davide Fissore, IT

Advanced Process Control, Process Design, and Food Processes & Technologies

Politecnico di Torino

João Henriques, PT

Team Leader – R&D Drug Product Development

Hovione

Bernadette Morel, NL

Scientist, Bioprocess Development & Application

DSM Biotechnology Centre

Dr. Paul Matejtschuk, UK

Principal Scientist & Section Head, Standardization Science / Analytical & Biological Sciences Division

NIBSC

Dr. Audrey Maudhuit, FR

European Process Engineer

Fluid Air

Xulei Wu, US

Senior Food Scientist

Space Food Systems Laboratory / Human Health and Performance Contract / MEI Technologies | NASA

Carlo Marconi, IT

General Manager BU Inspection Machines

Antares Vision