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 2019 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 call for speakers is open now.
Please find below the tentative schedule. Speaking sessions will be grouped according to similar themes into blocks and published upon finalizing the agenda, so please check back!
07:50 Registration and Welcome Coffee
08:30 Opening Address from the Chairman
08:40 Evaluation of an innovative spray freeze drying method and comparison to standard lyophilization.
09:20 Speed Networking
10:00 MTM / BTM – a perpetual PAT Tool for Batch Based Lyo-Cycles.
With the beginning of industrial freeze drying in the late 40ies, a dynamic control procedure has been introduced. Based on steady scientific efforts, the performance of this procedure has been continuously improved. Though, this method has now become a robust detection procedure for the sublimation pressure at the ice front, there is still optimization potential remaining. The presentation will provide an historical overview and will discuss pro & cons of this measurement procedure. Finally an outlook will be provided.
10:40 Morning coffee and networking break
11:10 Overview and practical use of PAT-tools for the freeze drying process development.
11:40 Impedance Spectroscopy: Recent Developments as a Process Analytical Technology for Pharmaceutical Freeze-Drying.
12:20 Business lunch
13:30 Freeze-Drying of High Concentration Biologics.
14:10 Ever tried. Ever failed. No matter. Try again. Fail again. Fail better! A (more) rational approach to lyo cycle development.
14:50 Afternoon coffee and networking break
15:20 Anatomy of the Lyophilization Process: Considerations for a Successful Tech Transfer.
16:00 Scale-Up, Process Transfer and Improving Predictive Outcome for Lyophilized Drug Product.
16:40 A Continuous and Controlled Pharmaceutical Freeze-Drying Technology for Unit Doses.
Driven by growing needs in the biopharmaceutical market and regulatory pressure, a continuous and controlled freeze-drying technology for unit doses to preserve biopharmaceuticals has been developed. Such continuous process allows a more efficient, cheaper, greener and controllable manufacturing method compared to traditional batch production systems, offering competitive advantages and business opportunities. Pharmaceutical freeze-drying (lyophilization) is a low-temperature drying process in which aqueous solutions of heat-labile biopharmaceuticals are converted into solids with sufficient stability for distribution and storage. Similar to all manufacturing processes of drug products (solids, semi-solids and liquids), conventional pharmaceutical freeze-drying is generally accomplished using batch processing that is considered time-consuming, costly, non-flexible and lacking robust quality control and real-time release. Four major industrial drivers are demanding a more efficient and better controllable pharmaceutical freeze-drying technology for unit doses: costcutting, regulatory pressure, a fast growing biopharmaceutical market and an ageing population requiring more personalized medicines. The continuous and controlled freeze-drying technology, developed following the principle of model based design, offers clear advantages over current batch production such as cost reduction (up to 50%), track-and-trace product quality control, and a significant reduction of processing time (> 40 times faster, e.g. 1 hour instead of 5 days at a vial level), reduced need for clean room and a substantial sustainability gain.
17:20 Panel Discussion
17:50 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 Inactivated Zika virus vaccine – fast track drug product development – formulation and lyophilization design space study.
The Zika virus (ZIKV) epidemic which occurred throughout Latin America, led The World Health Organization (WHO) to declare a Public Health Emergency of International Concern (PEIC) in February 2016. An inactivated Zika vaccine, developed by the Walter Reed Army Institute of Research, was found to be protective in animal models.
This vaccine was transferred to Sanofi Pasteur where the viral seed was regenerated in serum-free Vero cells and process development was carried out to produce material to be used for further pre-clinical and clinical evaluation.
The case study reported here focuses on the fast track drug product development with a strategy driven by a process/ product risk analysis to support the selection of the appropriate stabilizing formulation and freeze-drying process.
Finally a Design of experiment approach is presented where the combination effect of formulation and lyophilization parameters are assessed in a design space study.
This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO1002016000039C.
09:20 In silico modelling of freeze drying processes.
Development of protein therapeutics formulation relies on the selection of excipients that stabilize protein and/or prevent aggregation.
Experimental strategies to optimize formulations use force degradation studies and involve screening many combinations of excipientsand buffers. However, these effective methods do not readily provide information on intermolecular interactions responsible for the protective effects of excipients.
In silico methods may be employed to evaluate interactions that may form between selected therapeutics during freeze drying pharmaceutical formulations. A combination of molecular docking methods has been successfully utilized to predict hotspots for protein excipient interfaces on a model protein, which were confirmed by molecular dynamics in presence of explicit solvent and buffer components.
Furthermore, simulated annealing simulations of freezing and drying processes provide insights into protective effects of formulations on a molecular level.
This combination of approaches could provide information about the interactions of excipients in formulations and guide the computer aided development of future formulations.
10:00 Morning coffee and networking break
10:30 A new Freeze dried forming technology, a new type of fast consumable products.
11:10 Container Closure Integrity Testing using deterministic techniques like He-leak.
11:50 Business lunch
13:00 GMP and Occupational Safety Requirements for Lyophilization of high potent/toxic substances.
13:40 Lyophilization: Silicon oil contamination risk and mitigation strategies.
14:20 Afternoon coffee and networking break
14:50 Smart rubber stopper selection for Lyophilization.
15:30 Innovations in Drying Processes for Biopharmaceuticals.
16:10 Panel Discussion
16:50 Chairman’s closing remarks and end of summit
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chaired a panel discussion on the digitisation of clinical trials and next gen injectable devices, with speakers from Novartis, Roche, Janssen, Sanofi, SHL Group and Corvus Device.