Středa, 13. Únor 2019, Novotel Praha Wenceslas Square Hotel, Pharmaceutical Lyophilization Summit 2019

Od 13. Únor 2019 - 8:00
Do 14. Únor 2019 - 19:00

Novotel Praha Wenceslas Square Hotel

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Our website: Pharmaceutical Lyophilization Summit 2019
We are honoured invite you to participate at the Pharmaceutical Lyophilization Summit 2019, happening in 13-14 February, 2019.
Venue: Novotel Praha Wenceslas Square Hotel, Katerinska 38, 12000 Prague, Czech Republic.
Joining companies: Bayer, Bayer Pharmaceuticals, De Montfort University, Boehringer Ingelheim, Shire, MSD International, Lonza AG, Ghent University, Sanofi, UCL School of Pharmacy, Weibo Hi-tech Group, Datwyler Pharma Packaging International NV, ****** AG, Novartis, iQ-mobil solutions GmbH/Tempris, Vaxxinova Int., Laboratoire Aguettant, Martin Christ Gefriertrocknungsanlagen GmbH, BIOCAD, Takeda Vaccines, Goethe Biotechnology have all confirmed their participation.

CONFERENCE OVERVIEW:
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.
 
BRONZE SPONSORS:

Martin Christ Gefriertrocknungsanlagen GmbH
Weibo Hi Tech Biotechnology Company
Goethe Biotechnology GmbH
PIGO

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SPEAKERS BOARD:

Stefan Schneid | Laboratory Head Formulation Development Parenterals | Bayer, DE
Georg Frinke | Facility & Process Engineer | Bayer Pharmaceuticals, DE
Dr. Frank Harms | Managing Director | Martin Christ Gefriertrocknungsanlagen GmbH, DE
Prof. Geoff Smith | Professor of Pharmaceutical Process Analytical Technology | De Montfort University, UK
Torsten Schultz-Fademrecht | Scientist Pharmaceutical Dev. Biologicals | Boehringer Ingelheim, DE
Michael Dekner | Head Fill&Finish Life Cycle Management support | Shire,, AT
Anthony Cannon | Regional Director, ExM, Global Tech Ops, Sterile | MSD International, CH
Georg Frinke | Facility & Process Engineer | Bayer Pharmaceuticals, DE
Orla McGarvey | Principal Group Leader, Drug Product Process Development | Lonza AG, CH
Thomas De Beer | Professor at Ghent University – CTO of RheaVita | Ghent University, BE
Florent Peral | Formulation Scientist - Bioprocess R&D | Sanofi, FR
Prof. Mire Zloh | Honorary Professor | UCL School of Pharmacy, UK
Hewei Li | Chief Engineer & CEO | Weibo Hi-tech Group, CN
Bram Jongen | Head of R&D, PPS | Datwyler Pharma Packaging International NV, BE
Richard Denk | Head of Sales Containment | ****** AG, CH
Martin Frei | Process expert, Novartis Technical Operations | Novartis, CH

 
CONFERENCE PROGRAMME:
 
Day 1st | Wednesday, 13 February 2019
 
07:50 - Registration and Welcome Coffee
08:30 - Opening Address from the Chairman
PART #1: MANUFACTURING & PROCESS DEVELOPMENT
08:40 - Evaluation of an innovative spray freeze drying method and comparison to standard lyophilization.

Introduction and application examples
Case study for pharmaceutical development
Pro’s and Con’s of each technology, Outlook

Stefan Schneid Laboratory Head Formulation Development Parenterals - Bayer, DE
09:20 - Speed ​​Networking
10:00 - MTM / BTM – a perpetual PAT Tool for Batch Based Lyo-Cycles.

History, Current state and Latest development
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.

Georg Frinke Facility & Process Engineer - Bayer Pharmaceuticals, DE
10:40 - Morning coffee and networking break
11:10 - TBA.
Dr. Frank Harms Managing Director - Martin Christ Gefriertrocknungsanlagen GmbH, DE
11:40 - Impedance Spectroscopy : Recent Developments as a Process Analytical Technology for Pharmaceutical Freeze-Drying.

Impedance spectroscopy for beginners
Through Vial Impedance Spectroscopy (TVIS)
Applications: (i) ice nucleation; (ii) 1° drying rate; (iii) product temperatures; (iv) Kv and Rp determination
Accelerated design space assessment

Prof. Geoff Smith Professor of Pharmaceutical Process Analytical Technology - De Montfort University, UK
12:20 - Business lunch
13:30 - Freeze-Drying of High Concentration Biologics.

What are high concentration biologics?
CMC issues for high concentrated biologics
Challenges encountered for freeze drying thereof

Torsten Schultz-Fademrecht Scientist Pharmaceutical Dev. Biologicals - Boehringer Ingelheim, Germany
14:10 - Lyo cycle development.
Michael Dekner Head Fill&Finish Life Cycle Management support - Shire, Austria
14:50 - Afternoon coffee and networking break
15:20 - Anatomy of the Lyophilization Process: Considerations for a Successful Tech Transfer.

Tech transfer of a lyophilized product
Overview of the lyophilization process and the critical process parameters
Specific focus on the technical considerations with analysis of the impact on the lyophilization recipe
Impact of deviations to the CPPs on the product quality during transfer activities

Anthony Cannon Regional Director, ExM, Global Tech Ops, Sterile - MSD International, Switzerland
16:00 - Scale-Up, Process Transfer and Improving Predictive Outcome for Lyophilized Drug Product.

Key considerations in Scale-up of a Freeze-Drying Cycle
Review of advancements in the Industry over the last 15 years
Case Study: ‘Development Scale to Pilot Scale and Beyond’

Orla McGarvey Principal Group Leader, Drug Product Process Development - Lonza AG, Spain
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.
Thomas De Beer Professor - Ghent University, Belgium
17:20 - Panel Discussion
17:50 - Chairman's closing remarks and end of day one
19:00 - Business dinner
 
Day 2nd | Thursday, 14 February 2019
08:00 - Registration and Welcome Coffee
08:40 - Opening Address from the Chairman
PART #2: FORMULATION DEVELOPMENT
08:50 - 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.
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.
Florent Peral Formulation Scientist - Bioprocess R&D - Sanofi Pasteur, France
09:30 - Use of in silico methods to study freeze drying.
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 excipients and 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.
Mire Zloh Honorary Professor. - UCL School of Pharmacy, United Kingdom
10:10 - Morning coffee and networking break
10:40 - A new Freeze dried forming technology, a new type of fast consumable products.

A new Freeze dried forming preparation which has higher drug loading will suitable for fast consumable products.
Brief introduction of I-sol Technology.
Technical Achievements of Weibo Hi-tech Group.
Future Development trend: Freeze-dried product, which is preservative free and high activity, will replace traditional liquid forms of skin care products & health food supplement.

Dr. Hewei Li Chief Engineer & CEO - Weibo Hi-tech Group, CN
PART #3: TESTING & MONITORING
11:20 - Container Closure Integrity Testing using deterministic techniques like He-leak.

Revision of USP , ‘Sterile Product Packaging – Integrity Evaluation’
Highlights of the different test methodologies
He-leak & Laser Based Headspace Analysis techniques

Bram Jongen Head of R&D, PPS - Datwyler Pharma Packaging International NV, Belgium
12:20 - Business lunch
PART #4: SAFETY & RISKS MITIGATION
13:20 - GMP and Occupational Safety Requirements for Lyophilization of high potent/toxic substances.

What are high potent/toxic substances
GMP Requirements for high potent/toxic substances
Cleaning and Cross Contamination Requirements for Lyophilization based on the PDE (Permitted Daily Exposure)
Occupational Safety Requirements

Richard Denk Head of Sales Containment - ****** AG, Germany
14:00 - Lyophilization: Silicon oil contamination risk and mitigation strategies.

Silicone oil in the freeze-drying process
Mass spectroscopy
Case study Silicon oil leakage

Detection
Remediation
Learnings and improvements



Martin Frei Process expert, Novartis Technical Operations - Novartis, Switzerland
14:40 - Afternoon coffee and networking break
PART #5: INNOVATIONS & ADVANCED TECHNOLOGIES
15:10 - Smart rubber stopper selection for Lyophilization.

Selection of a rubber stopper design intended for lyophilisation purposes
Reduction of stopper stickiness to lyophilisation shelves
Effect of the rubber formulation on moisture content
Low moisture rubber formulations and effect on the freeze-dried cake, combining different methods

Bram Jongen Head of R&D, PPS - Datwyler Pharma Packaging International NV, Belgium
15:50 - Panel Discussion
16:20 - Chairman's closing remarks and end of summit
 
CANCELLATION & SUBSTITUTION POLICY:
You may substitute a delegate at any time and at no extra cost.
Cancellations must be in a written notice.
Cancellations made 14 days or more before the event start date will be refunded less than 50% of the registration fee.
Cancellations made less than 14 days before the event start date will receive no refund. If you cannot attend an event due to illness or other unforeseen circumstances, you may transfer your delegate pass to another upcoming event within one year from original event start date.

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