Although lyophilization is an old process, it remains to be complex. Today we can see increased trend in aseptic freeze-dried products, including biologics, APIs, nanomaterials and new devices. It makes the lyophilization cycle more complicated. Lyophilization becomes systematic and scientific process.
Pharmaceutical Lyophilization Conference is a knowledge sharing to showcase best practices in technical and regulatory updates, manufacturing and process development, freeze-dried formulation, testing, monitoring and new products development.
The live sessions are over but registration is still open for those who wish to access all of the content available on-demand.
Complete conference package includes 12 sessions, plus 2 workshops with presentation recordings, slide decks, a list of participants, and other promotional materials for €295.
In case of doubt, please email us at info@qepler.com.
12:00 Registration
12:20 Opening Address
12:30 A 2020 hindsight look at how COVID-19 has affected the freeze drying industry and what we have learned from it.
Dr. Mattia Cassanelli,
Technical Manager – Consultancy, Biopharma Group, United Kingdom
13:00 Questions & Answers
13:10 Speed Networking
13:40 Taking into account Kv distribution in freeze drying simulation.
Theory of freeze drying was set up in the 80’s by pioneering work of Pikal. Although very simple (1D, quasi steady state), the model provides very good representation of the reality, the only limitation is that it uses average value. However it is well known that the edge vials are much hotter than center vials, due to radiation impact. This difference in temperature may result in heterogeneities in the product : if the cycle is too aggressive, edge vials may collapse, or if it the primary drying is too short some residual ice may still be present when the cycle is moving to secondary drying, leading to melt back. We will present a new process simulation methodology, based on the distribution of Kv’s which allows top predict the variability of product temperature and primary drying time. Real life examples will be discussed.
Jean-René Authelin,
Global Head of Pharmaceutical Engineering, Sanofi-Aventis, France
14:10 Questions & Answers
14:20 Break
14:30 TrackSense® LyoPro - Ellab all-in-one Solution for Qualification, Validation, Monitoring and Batch Control.
Roman V. Loretts,
Regional Manager, ELLAB A/S, Denmark
15:00 Questions & Answers
15:10 Aseptic Process Simulation for Lyophilization – Best Practice, an Industry Opinion
Michael Dekner,
Innovation & External Collaborations, Takeda, Austria
15:40 Questions & Answers
15:50 Heat transfer at sublimation – a theoretical assessment of experimental results.
Georg Frinke, Dipl.-Ing. (FH),
Senior Manager Engineering, Ferring GmbH , Bornheim, Germany
16:20 Questions & Answers
16:30 Break
16:40 Introducing TVIS PAT technology.
Prof. Geoff Smith,
Professor of Pharmaceutical Process Analytical Technology, De Montfort University, Leicester, United Kingdom
17:10 Through Vial Impedance Spectroscopy and its application in the freeze drying of biologicals.
Paul Matejtschuk,
Section Head, Standardisation Science, Analytical and Biological Sciences Division, National Institute for Biological Standards and Control (NIBSC), United Kingdom
17:40 Questions & Answers
17:50 Towards Realization of Continuous Drying Technologies for Biopharmaceuticals.
Dr. Sune Klint Andersen,
Principal Scientist DPD – Oral Solid Dosage, Janssen, Antwerp, Belgium
18:20 Questions & Answers
18:30 Closing remarks and end of day one
12:00 Opening Address
12:10 Freeze-Drying of Highly Concentrated Biologics
Dr. Patrick Garidel,
Head of Process, Purification and Pharma Development, Biopharma, Boehringer Ingelheim, Hamburg, Germany
12:40 Questions & Answers
12:50 Lyocycle Development and Transfer/Process Performance Qualification of an amorphous cyclodextrin based lyoproduct into production scale and experiences during routine production.
Dr. Andrea Weiland-Waibel,
Managing Director, Explicat Pharma GmbH, Germany
13:35 Questions & Answers
13:45 Break
13:55 WORKSHOP: Validation with Wireless Loggers - Practical Aspects and Experience from Ellab.
Roman V. Loretts,
Regional Manager, ELLAB A/S, Denmark
14:35 Questions & Answers
14:45 WORKSHOP: Role and measurement of mechanical properties in lyobeads technology.
The use of Lyobeads is becoming more popular within the Lyophilisation industry, due to their size and structure it is extremely important to understand the strength of the product and sustainability for their use. Utilising the MicroPress Mechanical Property Analyser, tests can be carried out on the Stress and Strain of the final product.
Ian Blackham,
Business Development Executive – Instruments, Biopharma Group, United Kingdom
Dr. Mattia Cassanelli,
Technical Manager – Consultancy, Biopharma Group, United Kingdom
15:45 Questions & Answers
15:55 Break
16:05 How to choose the optimal stopper for lyophilization application?
Dr. Simon Kervyn,
Manager Materials Development, Datwyler, Namur, Belgium
16:35 Questions & Answers
16:45 Primary Packaging Risk Mitigation: A Customized Physical and Chemical Evaluation.
Diego Zurbriggen,
Technical Account Manager, West Pharmaceutical Services, Inc., USA
17:15 Questions & Answers
17:25 Break
17:35 Freeze-drying of highly potent APIs using protective bags - Characterization of heat and mass transfer.
Matthias Erber,
Scientist External Cooperations, Bayer, Germany
18:05 Panel Discussion
18:45 Closing remarks and end of summit
To register to the summit as a Delegate, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.
*Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages".
To register to the summit as a Delegate, Exhibitor or Sponsor, please provide the details below. Once the form is submitted, we will send you the official confirmation and the invoice for payment. In case of doubt, contact us at info@qepler.com.
*Please note, all participation packages, contains complete conference materials distribution after the event (Slides, list of participants, stream and video recording). You don't need to order an additional "Documentation Packages".
Please fill in the details below to get the latest news, discounts, early-bird rates, and upcoming annual details.
Applied Materials, Inc., USA - Aspen, ZA - Azbil Telstar Technologies SLU, ES - Baxter Healthcare, USA - Bayer AG, DE - Biopharma Group, UK - Boehringer Ingelheim, DE - Cambridge Design Partnership, UK - Catalent Biologics, USA - Catalent Pharma LLC, USA - Catalent Pharma Solutions , UK - Cenexi Lt sa, BE - Daiichi-Sankyo Europe GmbH, DE -Datwyler Pharma Packaging International NV, BE - De Montfort University, UK - Dr. Reddy's lab, IN - ELLAB A/S, DK - eTheRNA Immunotherapies NV, BE - Explicat Pharma GmbH, DE - Ferring GmbH, DE - Fresenius Kabi Oncology Ltd., IN - GEA Lyophil GmbH, DE - GSK, USA - Hemofarm, RS - Illumina, UK - Janssen, BE - Jazz Pharmaceuticals, CA - Laboratorio Reig Jofre, S.A., ES - LMU Munich, Pharmaceutical Technology and Biopharmacy, DE - Lyofal, FR - Lyomark Pharma GmbH, DE - Medichem Manufacturing (Malta) Limited, MT - Merck, USA - Merck KGaA, DE - Minapharm for pharmaceutical products, EG - NIBSC, UK - OPTIMA pharma GmbH, DE - Pfizer, BE - PharmaMar SA, ES - RAUMEDIC AG, DE - Sanofi-Aventis, FR - Sirton Pharmaceuticals SpA, IT - Takeda, AT - Tempris GmbH, DE - Terumo BCT, USA - University of Helsinki, FI - West Pharmaceutical Services, USA - World Health Organization, CH - Yuria-Pharm LLC, UA - and others.
Allergan - Aptar Pharma - AZBIL TELSTAR TECHNOLOGIES SLU - Baxalta Manufacturing Sàrl - Bayer AG - BB-NCIPD Ltd. - Biopharma Process Systems Ltd - BLAC-BioPharma UG - Boehringer Ingelheim - Datwyler Pharma Packaging International NV - De Montfort University - DendroPharm GmbH - Elm o Sanat University - Freie Universität Berlin - Ghent University - INDICAL BIOSCIENCE GmbH - Janssen - KSHM-Rezonanca - Lek Pharmaceuticals d.d. - Lonza AG - Martin Christ Gefriertrocknungsanlagen GmbH - Masaryk University - MSD - MSD International - Novartis Global Drug Development / Technical Research & Development - Pensatech Pharma - Pfeiffer Vacuum GmbH - Pfizer - PharmaCept GmbH - Polpharma SA - Rhine Waal University - Sanofi - SCHOTT AG - Shire Austria GmbH now part of Takeda - Surface Measurement Systems Ltd. - Takeda - Tempris GmbH - VLB Berlin - West Pharmaceutical Services Deutschland GmbH & Co KG and others.
chaired a panel discussion with speakers from Shire, MSD, Bayer, Martin Christ, Boehringer Ingelheim, Ghent University, Lonza and De Montfort University.
