PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021
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3rd Annual PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021 29-30 July 2021 ● VIRTUAL CONFERENCE 12:00 - 18:30 CEST (Prague - UTC/GMT +2 hours) ▸ 12+ Program Hours ▸ WORKSHOPS ▸ Networking ▸ Panel Discussions | Q & A ▸ Video Recording WEB AGENDA LinkedIn GOLD PARTNER
Transcript of PHARMACEUTICAL LYOPHILIZATION SUMMIT 2021
3rd Annual
PHARMACEUTICAL LYOPHILIZATIONSUMMIT 2021 29-30 July 2021● VIRTUAL CONFERENCE 12:00 - 18:30 CEST (Prague - UTC/GMT +2 hours)
▸ 12+ Program Hours ▸ WORKSHOPS▸ Networking▸ Panel Discussions | Q & A▸ Video Recording
WEB AGENDA LinkedIn
GOLD PARTNER
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
SPEAKERS BOARD
Michael DeknerInnovation & External CollaborationsTakeda, AT
Diego ZurbriggenTechnical Account ManagerWest Pharmaceutical Services, USA
Dr. Andrea Weiland-Waibel Managing DirectorExplicat Pharma GmbH, DE
Ian BlackhamBusiness Development Executive – InstrumentsBiopharma Group, UK
Dr. Simon KervynManager Materials DevelopmentDatwyler Pharma Packaging International NV, BE
Dr. Patrick GaridelHead of Process, Purification and Pharma Development, BiopharmaBoehringer Ingelheim, DE
Prof. Geoff SmithProfessor of Pharmaceutical Process Analytical TechnologyDe Montfort University, UK
Paul Matejtschuk, PhD, CChem, FRSC Section Head, Standardisation Science,Analytical and Biological Sciences DivisionNIBSC, UK
Georg Frinke, Dipl.-Ing. (FH)Senior Manager Engineering Ferring GmbH, DE
Dr. Sune Klint AndersenPrincipal Scientist DPD – Oral Solid DosageJanssen, BE
Dr. Mattia CassanelliTechnical Manager – ConsultancyBiopharma Group, UK
Jean-René Authelin Global Head of Pharmaceutical EngineeringSanofi-Aventis, FR
Matthias ErberScientist External CooperationsBayer, DE
Roman V. LorettsRegional ManagerELLAB A/S, DK
PARTNER
TRACKSENSE® LYOPROA revolutionary wireless data logger specifically designed for accurate
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More than 100 transmittingdata loggers in one study
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Industry leading software
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TRACKSEN
SE®
LYOPR
O
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HOW IT WORKS
EVALUATE
SHAREValSuite works in a
Start the data loggers with the LyoPro Reader Station and program them using ValSuite
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Client/Server
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Features & Bene�ts
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WHO YOU WILL MEETSNAPSHOT OF ATTENDEES - VIRTUAL 2nd Annual Extractables & Leachables Conference 2020: 3P Biopharmaceuticals, ES - Abbott Healthcare Products B.V., NL - Abbvie Deutschland GmbH & Co. KG, DE - Accord-UK Ltd, UK - Advent Consulting Canada, CA - ALK, DK - Alkermes Pharma Ireland Limited, IE - Alphamed Formulations PVT LTD, IN - Apotex Research Pvt Ltd., IN - Aspen Holdings, ZA - Aspen Pharmacare, ZA - B.Braun medical SA, CH - Bavarian Nordic, DK - Becton Dickinson, CN - Becton Dickinson, FR - Biogen, USA - Boston Analytical, USA - Claudia Cusa, d.i., IT - CSL Behring AG, CH - Datwyler Pharma Packaging International NV, BE - DuPont, USA - DuPont-Asahi Flash Spun Products, JP - EirGen Pharma, IE - Eli Lilly and Company, USA - EMS SA, CH - Eurofins Analytical Science Laboratories, Inc., JP - Fujifilm Diosynth Biotechnologies, UK - GSK, US - GSK Vaccines, BE - Hall Analytical, UK - Hemofarm AD, RS - HTL-Strefa S.A., PL - Intertek (Schweiz) AG, CH - Janssen, USA - Kora Healthcare, IE - LEO Pharma, IE - Maven E&L Ltd, UK - Medline Industries, USA - Merck KGaA, DE - MilliporeSigma a business of Merck KGaA, USA - Novartis, CH - Novartis Pharma Stein AG, CH - NOVAVAX CZ a.s., CZ - Orexo AB, SE - Orion Corporation - FI, Philips, NL - Polifarma İlaç San. ve Tic. A.Ş., TR - PPD, IE - Rentschler Biopharma SE, DE - Safetree Consulting e.U., AT - Sandoz Manufacturing Inc., CA - Sanofi, FR - Sanofi, DE - Sanofi Pasteur, CA - Sartorius Stedim Biotech GmbH, DE - SCHOTT AG, DE - SCIEX, UK - Selvita S.A., PL - Septodont, FR - SGS, CN-TW - SGS Institut Fresenius GmbH, DE - Solvias AG, CH - Sthree, BE - Swedish Biomimetics 3000 Ltd, UK - Takeda Pharmaceuticals, USA - Vet-Agro Sp. z o.o., PL - West Pharmaceutical Services, USA - Wockhardt Ltd, IN - and others.
Agenda: https://qepler.com/agendas/agenda-2nd-extractables-and-leachables-20.pdf
SNAPSHOT OF ATTENDEES - 2nd Annual Pharmaceutical Lyophilization Summit 2020: 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.
Agenda: https://qepler.com/agendas/pharmaceutical-lyophilization-summit-2020.pdf
POSITIONS▸C-Level, Presidents, Chairs, Members of the Board & VPs▸Vice presidents, Directors, & Heads▸Leaders & Managers▸Principals, Engineers, Analysts & Scientists▸Instructors & Trainers & Teachers▸Advisors, Coordinators, Auditors & Consultants▸Other Professionals, Experts & Specialists
DIVISIONS▸Container Development & Container Closures▸Vials, Stoppers & Dual Chamber Systems▸Devices &Application Systems▸Product Development & Control▸Parenteral Production▸Injection Systems▸Vaccines▸Corporate & Business Development▸External Supply▸Sales & Marketing▸Outsourcing▸Partnerships & Alliances▸Strategic Development▸Other
▸QA/QC▸Characterisation▸Regulatory Affairs▸Stability▸Standardisation▸Qualification & Validation▸Scale-up & Technology Transfer▸Cycle Management▸Facility & Site Design & Management▸PAT, QbD▸Media Fills▸Visual Inspection▸Filling & Materials▸Materials Development
▸Lyophilization▸Pharmaceutical Manufacturing, Engineering & New Technologies▸Laboratory Management▸R&D▸Formulation▸Containment▸Pharmaceutical & Processing Development▸ Process Design, Technology, Analytics, Testing, Monitoring & Control▸Aseptic Production, Cleaning & Sterilisation▸Bioprocessing
INDUSTRIES▸Pharmaceutical▸Biotechnology▸Chemical▸Medical Devices▸CDMOs▸CMOs▸CROs
INDUSTRIES▸NOPs▸Regulatory Agencies▸Bioprocessing services and equipment▸Equipment suppliers▸Training providers▸Other
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
PHARMACEUTICALLYOPHILIZATION
SUMMIT2021
12:00 - 12:20 ✍ Registration
12:20 - 12:30 🎤 Opening Address from the Chairman
13:00 - 13:10 ⁉ Q & A
14:10 - 14:20 ⁉ Q & A
15:00 - 15:10 ⁉ Q & A
July 29 | 1st DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)
14:20 - 14:30 ☕ Break
12:30 - 13:00 A 2020 hindsight look at how COVID-19 has affected the freeze drying industry and what we have learned from it. ▸Main challenges in 2020 seen from the eyes of a CDMO ▸Development and manufacturing of PCR assay in lyocakes and lyobeads ▸Development of lyo candidate vaccines ▸Development of lyo blood products
Dr. Mattia Cassanelli | Technical Manager – Consultancy Biopharma Group, UK
13:40 - 14:10 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, FR
14:30 - 15:00 TrackSense® LyoPro Ellab all-in-one Solution for Qualification, Validation, Monitoring and Batch Control.
Roman V. Loretts | Regional Manager ELLAB A/S, DK
13:10 - 13:40 🤝 Speed Networking
15:10 - 15:40 Aseptic Process Simulation for Lyophilization – Best Practice, an Industry Opinion ▸Aseptic process simulation (APS) for lyophilized products. ▸Annex 1 revision in relation to APS. ▸Proposed best practice. Michael Dekner | Innovation & External Collaborations Takeda, AT
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15:40 - 15:50 ⁉ Q & A
PHARMACEUTICALLYOPHILIZATION
SUMMIT2021
July 29 | 1st DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)
17:40 - 17:50 ⁉ Q & A
18:20 - 18:30 ⁉ Q & A
16:30 - 16:40 ☕ Break
17:10 - 17:40 Through Vial Impedance Spectroscopy and its application in the freeze drying of biologicals. ▸Simple excipients to complex formulations ▸Identification of “in vial” freezing and primary drying events ▸Monitoring of location and its impact on drying
Paul Matejtschuk, PhD, CChem, FRSC | Section Head, Standardisation Science,Analytical and Biological Sciences Division National Institute for Biological Standards and Control (NIBSC), UK
17:50 - 18:20 Towards Realization of Continuous Drying Technologies for Biopharmaceuticals. ▸Challenges in drying of biopharmaceuticals ▸Aseptic Spray Drying ▸Continuous & Controlled Single Vial Lyophilization ▸Continuous manufacturing pros and cons for various technologies
Dr. Sune Klint Andersen | Principal Scientist DPD – Oral Solid Dosage, Janssen, BE
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18:30 - 18:40 🎤 Closing remarks and end of Day 1
Introducing TVIS PAT technology. ▸Process analytical technologies (PAT) for freeze-drying ▸Dielectric properties of frozen solutions ▸Non-invasive spectroscopic PAT methods Prof. Geoff Smith | Professor of Pharmaceutical Process Analytical Technology De Montfort University, UK
16:40 - 17:10
16:20 - 16:30 ⁉ Q & A
15:50 - 16:20 Heat transfer at sublimation – a theoretical assessment of experimental results. ▸Variable heat transfer on the shelf, reasons of edge effect ▸Calculation of drying progress ▸Experimental validation based on different PAT-Tools ▸Assessment of current Qualification procedures ▸Risk mitigation for cycle transfer Georg Frinke, Dipl.-Ing. (FH) | Senior Manager Engineering Ferring GmbH, DE
PHARMACEUTICALLYOPHILIZATION
SUMMIT2021
12:00 - 12:10 🎤 Opening Address from the Chairman
12:40 - 12:50 ⁉ Q & A
13:35 - 13:45 ⁉ Q & A
15:45 - 15:55 ⁉ Q & A
July 30 | 2nd DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)
13:45 - 13:55 ☕ Break
12:10 - 12:40 Freeze-Drying of Highly Concentrated Biologics. ▸Challenges for processing highly concentrated protein formulations. ▸Freeze-drying of concentrated protein solutions. ▸Analytics & stability properties of HCFDF. ▸Impact on reconstitution.
Dr. Patrick Garidel | Head of Process, Purification and Pharma Development, Biopharma Boehringer Ingelheim, DE
12:50 - 13:35 Lyocycle Development and Transfer/Process Performance Qualification of an amorphous cyclodextrin based lyoproduct into production scale and experiences during routine production. ▸Critical Quality Attributes of Lyo Products. ▸The Critical Formulation Temperature and the rational design of the lyocycle. ▸Lyocycle robustness and the Transfer/PPQ into routine production. ▸Ongoing Process Verification during lifecycle, experiences during routine production. Dr. Andrea Weiland-Waibel | Managing Director Explicat Pharma GmbH, DE
14:45 - 15:45 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. ▸Lyobead technology.▸Uses of Lyobeads.▸How to determine the strength of your Lyobead.▸What can influence weakness within the Lyobead. Ian Blackham | Business Development Executive – Instruments Dr. Mattia Cassanelli | Technical Manager – Consultancy Biopharma Group, UK
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14:35 - 14:45 ⁉ Q & A
15:55 - 16:05 ☕ Break
13:55 - 14:35 WORKSHOP: Validation with Wireless Loggers Practical Aspects and Experience from Ellab. ▸Pre- and Post- Calibration ▸Introduction and placement ▸Data analysis and report generation ▸Time savings Roman V. Loretts | Regional Manager ELLAB A/S, DK
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PHARMACEUTICALLYOPHILIZATION
SUMMIT2021
July 30 | 2nd DAY Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)
16:35 - 16:45 ⁉ Q & A
18:45 - 18:55 🎤 Closing remarks and end of summit
17:25 - 17:35 ☕ Break
16:05 - 16:35 How to choose the optimal stopper for lyophilization application? ▸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. ▸Moisture determination using Karl-Fisher versus Loss-on-Drying. ▸Low moisture rubber formulations and effect on the freeze-dried cake, combining different methods. Dr. Simon Kervyn | Manager Materials Development Datwyler Pharma Packaging International NV, BE
16:45 - 17:15 Primary Packaging Risk Mitigation: A Customized Physical and Chemical Evaluation. ▸Review primary packaging risks impacting lyophilized drug product quality. ▸Holistic understanding of the drug product manufacturability and fit for purpose. ▸Plan a chemical and physical performance testing design based on drug product requirements. ▸Assess testing results for drug product risk mitigation. Diego Zurbriggen | Technical Account Manager West Pharmaceutical Services, USA
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17:35 - 18:05 Freeze-drying of highly potent APIs using protective bags - Characterization of heat and mass transfer. ▸Case study on the usage of protective bags during Freeze-Drying ▸Concept of blow-out as a contamination/safety issue ▸Relevance and value of sublimation tests to understand your process ▸Influence of protective bags on your freeze-drying process Matthias Erber | Scientist External Cooperations Bayer, DE
18:05 - 18:45 Panel discussion
17:15 - 17:25 ⁉ Q & A
PHARMACEUTICALLYOPHILIZATION
SUMMIT2021
SPEAKER’S BIOGRAPHIES
Michael DeknerInnovation & External Collaborations Takeda, AT
Michael Dekner has studied biotechnology at the University of Life Sciences Vienna. Since graduating 16 years ago he has held positions as scientist in enzyme engineering (Biomin), antibody design (f-Star), since joining Takeda as a supervisor for lyophilization and crimping, manager for process and technology innovation and has lead a team of scientists developing and optimizing fill and finish processes. Currently Michael holds the position of associate director for innovation and external collaboration
Dr. Simon KervynManager Materials DevelopmentDatwyler Pharma Packaging International NV, BE
Simon Kervyn graduated as a PhD in organic chemistry and materials from the University of Namur, Belgium in 2012. After research stays at National Institute of Materials Sciences in Tokyo and at UCLA, Los Angeles, he worked at the Coatings Research Institute in Belgium.He is now working for Datwyler as manager surface development. In this position he performs customer’s dedicated research to optimize the selection of rubber components to their applications. Furthermore, he works on the development of coated products for the Datwyler portfolio. He is a frequent speaker at conferences.
Georg FrinkeSenior Manager Engineering Ferring GmbH, DE
Georg Frinke is employed as senior manager Engineering at Ferring Kiel and engaged as a honorarium professor at the DeMontfort University of Leicester. He has 20 years of experience in the field of pharmaceutical freeze drying.
Dr. Patrick GaridelHead of Process, Purification and Pharma Development, BiopharmaBoehringer Ingelheim, DE
Dr. Patrick Garidel is currently employed as associate director protein science at Boehringer Ingelheim Pharma GmbH & Co. KG. His activities are focused on the development biologics from the downstream process to drug product (liquid and solid formulations, freeze-drying). His expertise covers: development of drug delivery system and formulations, packaging/devices, process development, bio-analytic, and protein purification. He is responsible for the establishment of innovative platform technologies for e.g. powder inhalation, gene therapy, in silico based predictive tools for molecule properties, and particle analytics. Additionally, he is interested in the development of new concepts and strategies for protein purification, stabilisation, delivery and protein/ colloid chemistry in general. PG studied chemistry and biotechnology at the University of Kaiserslautern and pharmaceutical sciences at the University of Strasbourg. He has a PhD in biophysics. During his academic career, he took over various post doc positions at the Institute for Pharmaceutical Technology and Biopharmacy, physical chemistry at the Martin Luther University Halle/ Wittenberg, DESY, Rutgers University and Hospital for Special Surgery.
Prof. Geoff SmithProfessor of Pharmaceutical Process Analytical TechnologyDe Montfort University, UK
Geoff Smith is Professor of Pharmaceutical Process Analytical Technology in the Leicester School of Pharmacy at De Montfort University (UK). His research group focusses on pharmaceutical applications for impedance, dielectric and terahertz spectroscopies alongside optical techniques such as laser speckle and optical flow. He is responsible for the development of through-vial impedance spectroscopy (TVIS) as a PAT tool for monitoring phase behaviour (ice formation and eutectics), ice interface temperatures, primary drying rates and end points. This development marks the first time that impedance spectroscopy has been used to characterize materials within conventional glass freeze-drying vials, without having to insert the electrodes into the product (i.e. the solution under-going freeze-drying). This feature of the technology sets it apart from other in-process impedance measurement systems, in which a bulky electrode assembly is inserted into the solution being freeze-dried, to provide a product-non-invasive technology.
Ian Blackham Business Development Executive – Instruments Biopharma Group, UK
Ian joined the Biopharma Group in July 2019 and currently works as the Business Development Executive for the Lyophilisation Instruments Division which includes Freeze Drying Microscopes, Lyotherm DTA & Impedance Analysers and MicroPress Mechanical Property Analysers. With over twenty-five years’ experience within the cryopreservation industry, Ian is now utilising his knowledge of critical temperatures within the Lyophilisation sector, helping to provide the scientific data to ensure the correct parameters are understood when Lyophilising various product formulations. Over the years Ian has been an advisor to many sectors on the safe storage conditions of biological products from small single cell samples to large tissue storage.
Paul MatejtschukHead of Process, Purification and Pharma Development, BiopharmaNational Institute for Biological Standards and Control, Medicines & Healthcare products Regulatory Agency, UK
Paul Matejtschuk (BSc, PhD, CChem, FRSC) is a Principal Scientist, and lead the Standardization Science Section in the Analytical & Biological Sciences Division at the National Institute for Biological Standards & Control (NIBSC), a centre of the Medicines and Healthcare products Regulatory Agency , whose mission is to safeguard the quality of biological medicines. NIBSC is also designated a WHO International Laboratory for Biological Standardization. His team is focused on delivering formulation and lyophilization conditions for a wide range of biological reference materials and research interests include the relationship between structure and stability in biologicals, thermal analysis and methods for the characterization of lyophilized proteins. Paul has 35 years postdoctoral experience working in both academia and industry in the areas of biologicals, has co-authored many peer-reviewed papers and has broad experience across downstream processing, formulation and characterization. He is a Director of the International Society for Lyophilization/Freeze Drying (www.islyophilization.org), membership officer of the Thermal Methods Group of the Royal Society of Chemistry (www.thermalmethodsgroup.org.uk) and in 2019 co-edited with Dr Kevin Ward “Lyophilization of Pharmaceuticals & Biologicals - New Technologies & Approaches for Springer Humana Press ( https://link.springer.com/book/10.1007%2F978-1-4939-8928-7)
Dr. Sune Klint AndersenPrincipal Scientist DPD – Oral Solid DosageJanssen, BE
Dr. Andersen is a principal scientist in spray drying and enabling technologies at Janssen Research & Development, Belgium. He has an MBA in management & technology and a PhD in chemical engineering, with a specialization in nanoparticle technology. His main interests and experience include the development of drying processes for drug products, drug substances, intermediates, excipients for both R&D and industrial scale purposes, application of quality-by-design in drying processes, validation and qualification of spray dryers, advantages & disadvantages of spray vs freeze-drying processes, continuous manufacturing, and enabling technologies for drug products.
Dr. Mattia Cassanelli Technical Manager – Consultancy Biopharma Group, UK
Mattia joined Biopharma Group in February 2018 and he currently works as a Technical Manager of the Consultancy Division, providing support through desktop study, cycle audit, characterisation of the material pre- and post- process, formulation development, optimisation of the freeze drying cycle and tech transfer/scale-up.Mattia’s background includes a PhD focussed on drying mechanisms of hydrocolloids in the food industry from a microstructural point of view at the University of Birmingham.He also gained a Master’s Degree in material engineering, and a Bachelor’s Degree in industrial engineering completed at the University of Trento, Italy.
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PHARMACEUTICALLYOPHILIZATION
SUMMIT2021
SPEAKER’S BIOGRAPHIES
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
Andrea Weiland, Ph.D.Managing Director Explicat Pharma GmbH, DE
Andrea Weiland, Ph.D., is managing director of Explicat® Pharma GmbH, a company providing technical project management services and pharmaceutical development services to the Pharmaceutical Industry (CMC).Andrea is a pharmacist with a Ph.D. in pharmaceutical technology on biodegradable microspheres and cyclodextrins . She held several leadership positions within Pfizer, working as project manager in process technology and within R&D where she was responsible scientist for pharmaceutical development (Phase I - III, candidate characterization and lyophilisation projects).
Diego ZurbriggenTechnical Account Manager West Pharmaceutical Services, USA
Mr. Zurbriggen has over 20 years of analytical lab experience, 10 of which focused on inorganic trace level analysis. As Technical Account Manager within the Technical Customer Support group of West, the focus of his role is to provide technical support relating to West’s packaging components and delivery systems for injectable drugs and healthcare products. He serves as the West subject matter expert on Extractables & Leachables, including elemental impurities. Prior to this role, he was Supervisor of the Leachables/Stability group in the Analytical Labs division of West Pharmaceutical Services, Inc., the focus of his role was to develop and validate leachables methods. Mr. Zurbriggen holds a Bachelor of Science/Chemistry degree from the Gewerbliche Berufsschule Visp – Visp, Valais, Switzerland.
Jean René AuthelinGlobal Head of Pharmaceutical Engineering Sanofi-Aventis, FR
Jean René Authelin has an Engineer degree in chemical Engineering from ENSIC (Nancy France), and a PhD from The Institut National Polytechnique de Lorraine (France). He joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s he founded the Physical Quality function, dedicated to the API crystallization , drying, polymorphism… for which he was for 10 years Global Head in Rhone Poulenc Rorer, Aventis and finally sanofi . In, 1988 JR Authelin was nominated Global Head of Pharmaceutical Engineering. Domains of interest of JRA include: thermodynamics of hydrates, drug polymorphism, amorphous solids physics, drug stability, crystallization, nanoparticles engineering and processing, drying , milling; spray drying, fluid bed granulation, roller compaction, freeze drying. Jean René Authelin is the author or co-author of 20 publications or book chapters and the co-inventor of 9 patents.
Roman V. LorettsRegional Manager ELLAB A/S, DK
With his radio engineering background Roman started back in Russia as Senior Advisor at the Trade Council, being part of the Ministry of Foreign Affairs of Denmark. Relocating to Denmark in 2011, Roman engaged with ELLAB for development and support of life science customers within CEE region. He personally visited top pharmaceutical companies in 25+ countries for exchanging knowledge and experience within thermal validation field. Roman is regular speaker at PDA, ISPE, WFHSS, C&VS and other specialized events, arranging customer training programs and webinars, responsible for localization and registration of ELLAB products and currently focusing on activities within markets of India, Russia, and Turkey. After acquiring Hanwell Monitoring solutions in 2019, Roman has been deeply involved into integration of monitoring products within Ellab Group as well.
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VIRTUAL - 3rd Annual Pharmaceutical Lyophilization Summit 2021
© All rights reserved Qepler s.r.o. 2020
PACKAGE NAME Standard price
Individual ticket - 1st Day (29th July 2021) - (*includes 1st Day’s post-event conference materials distribution) €195
Individual ticket - 2nd Day (30th July 2021) - (*includes 2nd Day’s post-event conference materials distribution) €195
Individual ticket - 2 Days - (*includes complete post-event conference materials distribution) €295
Group ticket - 2 Days (*2-3 delegates) - (*includes complete post-event conference materials distribution) €215
Group ticket - 2 Days (*4+ delegates) - (*includes complete post-event conference materials distribution) €145
Documentation package - (*if you have no plans to join the live conference) €395
Promotional materials distribution €445
SPEAKER SPONSOR - €995 PARTNER SPONSOR - €1295 GOLD SPONSOR - €1695
CONFERENCE MATERIALS: All participation tickets, already contains complete conference materials distribution package, including - slides, list of participants, stream and video recording. You don’t need to order an additional «Documentation Packages». Documentation package will be sent to the attendees within 72 hours after the event. The presentation content is subject to speaker’s companies approval for distribution.
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
MARKETING CAMPAIGN▸Website ▸Email Marketing ▸Digital Advertising ▸Social Marketing ▸Press ▸Direct Sales
PARTICIPATION FEEFees are inclusive of the complete summit materials, online post-event documentation/presentation package, list of participants, video records, and certificate of participation.
TRANSLATIONThe event translation link will be announced online and sent to the delegates within a reasonable period before the summit start date.
POST-EVENT DOCUMENTATIONPresentations and other materials will be sent to the attendees within 72 hours after the event. The presentation content is subject to speaker’s companies approval for distribution.
DISCOUNTSEarly booking discounts are not valid in conjunction with any other offers.
SPONSORSHIP PACKAGES:
BENEFITSSPEAKER
€995PARTNER
€1295GOLD€1695
Number of passes included 1 2 3
Registration fee for additional company representatives €195 €145 €95
Link to Landing Page/Video Presentation trough the live event translation. ● ●
Link to Virtual Exhibition Page trough the live event translation. ●
Opening keynote presentation 15 min
Speaking slot 20 min 30 min 30 min
Workshop slot 40 min
Recognition in chairman’s opening address ● ●
Opening & closing speech ●
Chairman of Day 1 ●
Chairman of Day 2 ●
Logo and URL on summit website, agenda and pre/post-summit communication activities ● ● ●
Recognition on Qepler social media channels (LinkedIn/Facebook/Twitter/Instagram) ● ● ●
Color advert placed on agenda 1/2 Page 1 Page
Online distribution of your company’s promotional materials to all attendees ● ●
ONLINE PACKAGES:
If you are unable to attend, you may purchase these packages
PACKAGE NAME PRICE
DOCUMENTATION (*if you have no plans to join the live conference) Post-event presentations with video records, list of participants and other materials. The presentation content is subject to speaker’s companies approval for distribution.
€395
PROMOTIONAL MATERIALS DISTRIBUTIONDistribution of your company’s promotional materials to all attendees €445
◀ WAYS TO [email protected]+420 608 030 490www.qepler.com
PARTICIPATION PACKAGES
EVENTS CALENDAR2021
PHARMA - MEDICAL DEVICES - CHEMISTRY
CLICK HERE TO REQUEST INFORMATION
Please choose the Summit / Summits and send us suggested Session Title via email or webpage.
We will appreciate if you share our calendar with your colleagues!
Denis PolikarpovExecutive Director
Tel: +420 608 030 490Email: [email protected]
Evgenia MakarCEO
Tel: +420 770 699 211Email: [email protected]
CONTACTSPlease send your session title and summit name to:
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2nd Genotoxic Impurities in Pharmaceuticals Summit ................................................................................................................................. July 15-16, 2021 ● VIRTUAL CONFERENCEGTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities. https://qepler.com/pdf/v2gti21.pdfREGISTRATION IS OPEN 3rd Annual Pharmaceutical Lyophilization Summit ...................................................................................................................................... July 29-30, 2021 ● VIRTUAL CONFERENCEDiscuss best practices in tech & regulatory updates, process, formulation, testing, monitoring, new products development.https://qepler.com/pdf/v3lyo21.pdfREGISTRATION IS OPEN
2nd Annual Inhaled Drug Delivery Summit ................................................................................................................................................... August 5-6, 2021 ● VIRTUAL CONFERENCEAssess and harness novel approaches to the development of inhaled drug products for enhanced patient care.https://qepler.com/pdf/v2idd21.pdfREGISTRATION IS OPEN
3rd Annual Highly Potent APIs Summit ........................................................................................................................................................ October 7-8, 2021 ● VIRTUAL CONFERENCEAssess and reduce manufacturing and handling challenges for highly potent active pharmaceutical ingredients.https://qepler.com/pdf/v3hpapi21.pdfREGISTRATION IS OPEN
3rd Annual Extractables & Leachables Summit ....................................................................................................................................... October 20-21, 2021 ● VIRTUAL CONFERENCEGet the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.https://qepler.com/pdf/v3el21.pdfREGISTRATION IS OPEN
3rd Annual Drug/Device Combination Products Summit ...................................................................................................................... December 2-3, 2021● VIRTUAL CONFERENCEGet up to date with the regulatory and quality compliance strategies for combination product development.https://qepler.com/pdf/v3ddcp21.pdfREGISTRATION IS OPEN
WEB AGENDA
WEB AGENDA
© All rights reserved Qepler s.r.o. 2021
WEB AGENDA
WEB AGENDA
WEB AGENDA
WEB AGENDA
🌎 www.qepler.com 📞 +420 608 030 490 📧 [email protected]
