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 Conference 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 featured talks on:

A 2020 hindsight look at how COVID-19 has affected the freeze drying industry and what we have learned from it.
Taking into account Kv distribution in freeze drying simulation.
TrackSense® LyoPro. Ellab all-in-one Solution for Qualification, Validation, Monitoring and Batch Control.
Aseptic Process Simulation for Lyophilization – Best Practice, an Industry Opinion.
Heat transfer at sublimation – a theoretical assessment of experimental results.
Introducing TVIS PAT technology.
Through Vial Impedance Spectroscopy and its application in the freeze drying of biologicals.
Towards Realization of Continuous Drying Technologies for Biopharmaceuticals.
Freeze-Drying of Highly Concentrated Biologics.
Lyocycle Development and Transfer/Process Performance Qualification of an amorphous cyclodextrin based lyoproduct into production scale and experiences during routine production.
Validation with Wireless Loggers. Practical Aspects and Experience from Ellab.
Role and measurement of mechanical properties in lyobeads technology.
How to choose the optimal stopper for lyophilization application?
Primary Packaging Risk Mitigation: A Customized Physical and Chemical Evaluation.
Freeze-drying of highly potent APIs using protective bags - Characterization of heat and mass transfer.

Who You Will Meet

By Position

C-Level, Presidents, Chairs & Members of the Board & VPs
CEOs, CMOs, CTOs, CQOs, CSOs & CROs
Directors, & Heads
Leaders & Managers
Chemists, Developers, Scientists & Engineers
Coaches, Consultants, Supervisors & Advisers
Qualified Persons
Other Professionals & Specialists

By Division

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
QA/QC
Characterisation
Packaging & Labelling
Risk Management
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
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
Sales Development
Strategic Development
Other

By Company Types

Pharmaceutical
Biotechnology
Chemical
Medical Devices
CDMOs
CMOs
CROs
NOPs
Regulatory Agencies
Bioprocessing services and equipment
Equipment suppliers
Training providers
Other

By Region

Central and Eastern Europe
North America
Middle East and Africa
Asia-Pacific
Other

Conference Programme

Day One - Thursday 29, July 2021

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)

12:00

12:20

12:30 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, United Kingdom

13:00

13:10 Speed Networking

13:40 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, France

14:10

14:20

14:30 TrackSense® LyoPro - Ellab all-in-one Solution for Qualification, Validation, Monitoring and Batch Control.

Roman V. Loretts,
Regional Manager, ELLAB A/S, Denmark

15:00

15:10 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, Austria

15:40

15:50 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
Risk mitigation for cycle transfer

Georg Frinke, Dipl.-Ing. (FH),
Senior Manager Engineering, Ferring GmbH , Bornheim, Germany

16:20

16:30

16:40 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, Leicester, United Kingdom

17:10 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,
Section Head, Standardisation Science, Analytical and Biological Sciences Division, National Institute for Biological Standards and Control (NIBSC), United Kingdom

17:40

17:50 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, Antwerp, Belgium

18:20

18:30

Day Two - Friday 30, July 2021

Tentative Schedule:

Central European Summer Time (CEST, Prague, UTC/GMT +2 hours)

12:00

12:10 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, Hamburg, Germany

12:40

12:50 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, Germany

13:35

13:45

13:55 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, Denmark

14:35

14:45 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, Biopharma Group, United Kingdom

Dr. Mattia Cassanelli,
Technical Manager – Consultancy, Biopharma Group, United Kingdom

15:45

15:55

16:05 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, Namur, Belgium

16:35

16:45 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, Inc., USA

17:15

17:25

17:35 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, Germany

18:05 Panel Discussion

18:45 Closing remarks and end of summit

Registration Form

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".

ONLINE Participation:

Summit Materials
ONLY

RECORDING

Video Recording
Slide Decks
List of Participants
Authorized Presentations ONLY

€295

2-Days Summit

Registration Form

To register to the summit as a Delegate, Exhibitor or Sponsor, 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.

Online Sponsorship:

Available until
29 July 2021

Speaker

Sponsorship Package

€995

1 pass included

Additional pass: €245

Session: 20 minutes

Logo and URL placement

Social media recognition

2-Days Summit

Available until
29 July 2021

Partner

Sponsorship Package

€1,295

2 passes included

Additional pass: €195

Session: 30 minutes

Logo and URL placement

Social media recognition

Colour advert in agenda: 1/2 page

Promotional materials distribution

Link to Landing page

2-Days Summit

Available until
29 July 2021

Gold

Sponsorship Package

€1,695

3 passes included

Additional pass: €145

Session: 40 minutes

Logo and URL placement

Social media recognition

Colour advert in agenda: 1 page

Promotional materials distribution

Link to Landing page

Link to Virtual Exhibition page

Keynote presentation: 15 minutes

Chairing of Day 1 or 2

2-Days Summit

Speaker Form

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

Your Details:

Title:
Mr. Ms. Mrs. Dr.

First Name:

Last Name:

Job Title:

Company Name:

Email:

Phone Number:

Country:

City:

Twitter link:

LinkedIn link:

Biography:

Session Information:

Session Title:

Session Overview:

Learning outcomes:

Tags (comma-separated):

Target audience:

Format:

Your role:

Click here to indicate that you have read and agree to the terms presented in the Terms and Conditions agreement. Click here to indicate that you have read and agree to the privacy policy in the Privacy Policy agreement.