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 Summit 2022 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.
8:30 Registration
9:00 Opening Address
09:10 The use of wireless temperature probes to understand heat transfer patterns in primary drying.
Dr. Mattia Cassanelli,
Technical Manager – Consultancy, Biopharma Group, United Kingdom
9:50 Speed Networking
10:30 Easify Your Lyo Process with Tempris.
A powerful PAT tool to pave your way to Pharma 4.0.
Anton Mangold,
Managing Director, Tempris GmbH, Germany
11:10 Morning coffee and Networking break
11:40 Application of Product Temperature measurement to monitor and control the Lyocycle using TEMPRIS.
Dr. Andrea Weiland-Waibel,
Managing Director, Explicat Pharma GmbH, Germany
12:20 Freeze drying process design using a Design Space approach
Mostafa Nakach,
Head of Formulation & Process Development / Biologics Drug Product Development, Sanofi, France
13:00 Business lunch
14:00 We need bigger crystals quo vadis controlled nucleation?
Michael Dekner,
Innovation & External Collaborations, Takeda, Austria
14:40 Where’s the true sublimation end point in primary drying?
Prof. Geoff Smith,
Professor of Pharmaceutical Process Analytical Technology, De Montfort University, Leicester, United Kingdom
15:20 Afternoon coffee and Networking break
15:50 The influence of formulation in freeze drying biologics
Paul Matejtschuk,
Section Head, Standardisation Science, Analytical and Biological Sciences Division, National Institute for Biological Standards and Control (NIBSC), United Kingdom
16:30 Panel Discussion
17:30 Closing remarks and end of day one
18:30 Business dinner
9:00 Opening Address
09:10 Anatomy of the Lyophilization Process: Considerations for a Successful Tech Transfer
Anthony Cannon,
Regional Director, ExM, Global Tech Ops, Sterile, MSD International, Zürich, Switzerland
09:50 Electrospinning as a Manufacturing Technique for Biopharmaceuticals.
Dr. Sune Klint Andersen,
Principal Scientist DPD – Oral Solid Dosage, Janssen, Antwerp, Belgium
10:30 Morning coffee and Networking break
11:00 GMP-ready continuous freeze-drying of pharmaceuticals
Thomas De Beer,
Professor, Ghent University, Gent, Belgium
11:40 Alternative Freeze Drying Technologies and Options for Process Intensification
Stefan Schneid,
Laboratory Head Formulation Development Parenterals, Bayer, Wuppertal, Germany
12:20 How different vial concepts can help to avoid breakage due to freezing
Diana Löber,
Global Product Manager Vials, SCHOTT AG, Göttingen, Germany
13:00 Business lunch
14:00 Impact of Elastomeric Closures on Freeze-dried Cakes
Lyo cake colour, aspect and integrity are fundamental quality control criteria to ensure a safe drug products. However, the lyo cake aspect can change after packaging if, for example, moisture content increase. The drug integrity could also be affected by a potential reaction with leachables from the elastomer stopper.
This talk will review the different elastomeric closure selection criteria to prevent modification of the lyo cake.
Dr. Simon Kervyn,
Manager Materials Development, Datwyler, Namur, Belgium
14:40 4040/40 Elastomer Formulation Innovation for Lyo Application
Francis Carroll,
Specialist, Technical Customer Support, EU, West Pharmaceutical Services, Inc., Ireland
15:20 Chairman’s closing remarks and end of summit
15:30 Afternoon coffee and Networking break
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".
Please fill in the details below to get the latest news, discounts, early-bird rates, and upcoming annual details.
Documentation Package for € 499 includes presentation slide decks and the delegate contact list.*
Please fill in all the details carefully and submit your application. Should you face any problems with filling the form, please contact us at info@qepler.com
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.
chaired a panel discussion with speakers from Shire, MSD, Bayer, Martin Christ, Boehringer Ingelheim, Ghent University, Lonza and De Montfort University.
