Early Bird discounts:
Register early to save € 300 for the Individual ticket, € 400 per person for 2-3 Delegates, € 500 per person for 4+ delegates from the same company until 29 November 2019.
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 2020 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.
07:30 Registration and Welcome Coffee
08:00 Opening Address from the Chairman
08:10 Workshop: Use of refrigereants in Freeze Dryers – Discussion and impact of current solutions.
09:10 Speed Networking
09:50 You don´t need to be great to start, but you need to start to be great – A pilot on multivariate monitoring for a lyophilized Product.
10:30 Morning coffee and networking break
11:00 Crystallization during freezing and drying: practical importance and characterization methods.
11:40 Z-FDM : A new instrument combining impedance spectroscopy with a freeze drying microscope.
12:20 Business lunch
13:20 Slot Reserved for a Gold or Silver Sponsor
13:50 Lyophilization and Biologics
14:30 Slot Reserved for a Booth or Bronze Sponsor
15:00 Afternoon coffee and networking break
15:30 Electrospinning of Biopharmaceuticals.
16:10 Case Study AVAILABLE
16:50 Case study by Sanofi-Aventis U.S. LLC, USA RESERVED
17:30 Roundtable Discussion
18:10 Chairman’s closing remarks and end of day one
19:00 Business dinner
08:00 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 To Be Announced
09:20 To Be Announced
10:00 Morning coffee and networking break
10:30 Lyophilization cycle development and scale-up for recipe conditions where Rp changes as function of shelf temperature.
Lyophilization is a complex process including several stages (freezing, primary and secondary drying).The selection of process conditions for each lyophilization step is extremely important with regards to the overall cycle duration and product quality attributes (e.g. appearance).
By using a mathematical modelling approach which requires measuring the heat transfer coefficient (Kv) and resistance to mass flow (Rp), the design space is constructed to predict the primary drying duration and maximum product temperature. Lyophilization recipe is then selected based on the defined design space. Conventionally, the approach used for the design space calculation takes into account that Rp change over time is not a function of the shelf temperature in the design space area.
The case study elaborates a model-assisted development and scale up of a lyophilization cycle with primary drying conditions where the temperature of the shelf exceeds the glass transition temperature (Tg’) and Rp over time is changing as a function of shelf temperature due to microstructural cake changes known as ‘cake micro-collapse’.
Salvatore Carmisciano, Msc.,
Head Project and Process Sciences, Novartis Global Drug Development / Technical Research & Development, Austria
11:10 Fogging in Lyophilization: Root cause investigation and the pursuit of fogging mitigation – a case study.
“Fogging” of the vial is a phenomenon often observed in freeze-drying. The formation of a dry powder haze, that sometimes also can show fingering or branching patterns, is primarily a cosmetic defect based on Marangoni flow that can become critical, when product is enclosed between stopper and vial neck. As a result, container closure integrity as well as dosing accuracy can be negatively influenced, leading to quite variable and unpredictable reject rates. In this case study the investigation process towards fogging mitigation for a therapeutic antibody is presented.
11:50 Business lunch
12:50 Slot Reserved for a Speaking Sponsor
13:10 To Be Announced
13:50 Risk Factors to Consider when Choosing the Optimal Stopper for Lyophilization.
Dr. Bettine Boltres,
Principal Scientific Affairs, Packaging & Delivery Systems, West Pharmaceutical Services Deutschland GmbH & Co KG, Eschweiler, Germany
14:30 Afternoon coffee and networking break
15:00 No compromises - vial strength by design.
In order to avoid breakage on filling lines or weaken the vials on their way to lyophilization, vial’s optimal strength characteristic plays a crucial role during the fill/lyo and finish process. Especially if the decision is taken to freeze-dry the product, the vial should not be the “disturbing factor” of the process in terms of yield.
There is a solution to increase vial’s strength, but at the same time compromising inner surface characteristics and therefore deteriorating its breaking behavior. This treatment is making the vial that though, that machine parts might break or wear out faster. New machine concepts need to be developed.
We at SCHOTT worked on a solution to increase vial’s strength whilst keeping its superior surface properties, and standard dimensions – no reregistration necessary. Finite element analysis – especially with strengths playing a role during lyophilization, strength testings/ fractography and study outcomes will be presented in this session.
15:40 Lyophilization: Silicon oil contamination risk and mitigation strategies.
17:00 Chairman’s closing remarks and end of summit
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Bachem AG - Bayer - Bayer Pharmaceuticals - BIOCAD - BioTestLab, Ltd - Boehringer Ingelheim - Boehringer Ingelheim Animal Health - CONTIPRO a.s. - CSL Behring AG - CSLBehring GmbH - Datwyler Pharma Packaging International NV - De Montfort University - Ghent University - GOETHE Biotechnology GmbH - iQ-mobil solutions GmbH/Tempris - Janssen Pharmaceutica NV - Kingston University London - Laboratoire Aguettant - Lonza AG - Lyofal - Martin Christ Gefriertrocknungsanlagen GmbH - MediWound - MSD International - Novartis - Oncomed manufacturing a.s. - Patheon - PIGO srl - Sanofi Pasteur - SFM Medical Devices GmbH - Shire - Skan AG - SP Scientific - Takeda - Takeda GmbH - Takeda Vaccines - UCL School of Pharmacy - Vaxxinova Int. - Weibo Hi-tech Group
chaired a panel discussion with speakers from Shire, MSD, Bayer, Martin Christ, Boehringer Ingelheim, Ghent University, Lonza and De Montfort University.