Lyophilization 2023 - Includes Workshop at GEA Opportunities and Challenges for the Pharmaceutical Industry

Lyophilization 2023 - Includes Workshop at GEA

Cologne, Germany

Course No 20544

This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager". Learn more.

 

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Speakers

Anthony Cannon, MSD, Switzerland
Richard Denk, SKAN, Switzerland
Maik Guttzeit, Bayer, Germany
Kristien Janssen, Pfizer, Belgium
Dr-Ing. Abdolreza Kharaghani, University of Magdeburg, Germany
Prof Alf Lamprecht, University of Bonn, Germany
Carlo Marconi, Antares Vision, Italy
Dr Andrea Weiland-Waibel, Explicat, Germany
Rita Welser, Boehringer Ingelheim Pharma, Germany

Objectives

Take advantage of the opportunity to focus on freeze drying technologies and processes and get a first hand demonstration of solutions for diverse requirements. Further, benefit from the workshop where you can get a hands-on experience in freeze drying yourself. In small groups, you will learn how the freeze drying output is affected by different equipment, parameter changes, solvents, etc.

Background

Lyophilization (or freeze drying) is one of the most exciting technologies in the pharmaceutical industry, although it is a very old process for the preservation of unstable materials. Trends are growing towards using non-aqueous Systems.

Additionally, Process Analytical Technology (PAT) / RTRT (Real Time Release Testing, Annex 17 of the EU GMP Guide) systems for in-line process monitoring are used to control and determine critical processing parameters. PAT plays also an important role in continuous lyophilization processes. According to ICH´s new guideline Q13 “continuous manufacturing (CM) has potential for improving the efficiency, agility, and flexibility of drug substance and drug product manufacturing”. Regulatory agencies have seen more companies engaged in the development and implementation of CM in recent years than in the past.

Modern QbD (Quality by Design) development following ICH Q8, Q9 and Q10 is based on the objective to design a lyophilization cycle applying a systematic and scientific approach instead of trial and error. Sufficient process understanding is essential to achieve a robust production process and efficient handling of post-approval changes (life cycle management according to ICH Q12) of a freeze drying process.

There is an increasing trend in aseptically produced lyophilized products, including peptides and proteins. Owing to the nature of these biological products, the lyo-cycle is more complicated and, in most cases, even longer than for other medicinal products.

The utility of lyophilization goes far beyond the vial. Principles of low temperature, low pressure can be applied to stabilize substances ranging from high potent APIs, novel medical devices, biologics and nanomaterials, freeze drying offers multiple opportunities.

Target Group

This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control, as well as engineers, project/facility engineers, especially those involved in the implementation of new monitoring methods for controlled nucleation, risk-based scale-up models and process technology for freeze drying processes. The conference is also of interest for participants working in the areas of container development and manufacturing process/packaging.

Workshops on Thursday, 25 May 2023

On the third conference day, you will have the opportunity to take part in several parallel workshops. For that purpose, several lyophilizers will be available at GEA. Experienced GEA experts will lead you in small groups, providing an intensive experience and directly applicable Know-how.
 
Workshops
 
  • Hands on Demonstration of Production Scale Freeze Dryer Design and Functions
    This workshop will provide each participant with an overview of a state-of-the-art production-scale freeze drying system, including system configuration. Also a small scale production freeze dryer that is applicable to be integrated into the VARIOSYS® Platform will be demonstrated.
  • Fundamentals of Freeze Drying, Cycle Development and Scale-up
    For effective freeze drying, each product requires a unique recipe (formulation); these formulations are initially developed on a laboratory or pilot-scale unit and it is imperative that formulation development takes both product characteristics and the limitations of pilot and production machines into account. This workshop will examine the procedures and consequences of process development and scale-up.
  • Live Demonstration of Automated Loading and Unloading Systems
    Demonstration of fully operational fixed and robotic load/unload system. Additionally, it will be possible to look at a system with special features, including online moisture control.
  • Workshop tour including visit of shelf manufacturing area, freeze dryer testing as well as simulation and system integration.
  • Innovations in Freeze Drying Applications
    This workshop will highlight new developments of production freeze dryer and includes technologies for controlled nucleation and continuous freeze drying.
A shuttle bus will bring you to Cologne Central Station at approximately 15.15 h. From Cologne Central Station, frequent airport connections are available.

It is highly recommended that you bring your own safety shoes, if available.

Programme

Please note: In certain cases, participation may not be possible due to competitive reasons.
 
Fundamentals of Freeze Drying
Basic concepts and processes
  • General advantages of freeze drying, product quality issues
  • Classification and comparison of freeze drying processes
  • Freeze drying in vials: Fundamentals of mass and heat transfer
  • Role and importance of freezing
  • Influence of process parameters, material properties, dryer design
  • Process optimization, monitoring and control
  • Freeze drying of frozen particles: Fundamentals of heat transfer, influence of mixing
Lyo-cycle Development and PAT-based Optimization
  • Critical quality attributes and critical process parameters:
    • assessment of critical process parameters through robustness testing to establish the process boundaries as the basis for the transfer from lab to commercial scale
  • Freeze drying scale-up and validation:
    • process qualification/validation in lyophilization strategies in relation to FDA/EMA modern process validation guidelines
  • Process control strategies:
    • hot and cold spot Determination to allow for process control by using a product temperature PAT device
Containment: Lyophilization of Highly Potent Compounds
Freeze dryer equipped with isolator
  • An introduction to highly potent products
  • Which are the critical limits and how are they evaluated?
  • Correlation between critical limits and cleaning validation
  • Determination of critical process steps
  • Hardware solutions
  • Examples
Lyophilization Technology - Design Requirements and Technical Solutions
  • Main components of a lyo (chamber, condenser, refrigeration skid, vacuum skid, shelves, etc.)
  • Purpose of these components
  • Design criteria of these components (temperature homogeneity, cooling and heating capacity, sublimation capacity and gas flow, etc.)
Freeze Dryers in Aseptic Production Lines – Challenges and Chances
  • Automatic Loading and Unloading of Freeze Dryers
  • FD cycles: monitoring and challenges
  • Turn-over times
  • Lyoplus
  • Steps towards higher sustainability
Aseptic Process Simulation (Media Fills)
  • Media Fill Design
  • Worst-case parameters for Media Fills
  • Validation of lyophilization processes with Media Fills
  • Requirements for Media Fills
  • Trends with regards to Media Fills
Atmospheric Spray Freeze Drying
  • Process understanding, monitoring & control
  • Design of continuous lyophilization
Implications of the new Annex 1
  • EU GMP Annex 1 – What´s new?
  • GMP Issues in Inspections & Requirements for:
    • Sterile manufacturing of Lyo products
    • Sterile packaging materials
Qualification/Validation - to get the System tested
  • Risk assessment in the context of qualification and validation
  • QbD aspects for successful lyophilization projects
  • Tests during qualification and validation
  • IQ/OQ/PQ
  • Concepts for reduced testing approach
  • Definition of scope of supply (URS vs. supplier standard)
  • Risk based life cycle approach in accordance with GAMP 5
LYO-CHECK: Next Level Automatic Visual Inspection & CCIT for Lyophilized Products
  • Dedicated illumination patterns, wavelengths and advanced imaging techniques
  • Particles detection dedicated optical setup
  • LYO Handling & Inspection: how to avoid product dirt and damages
  • How AQL sampling was integrated into the LYO and powder inspection process of a primary pharma manufacturer
  • Applicable CCIT and Process Analytical Technologies via non-destructive methodologies
  • AI Empowerment

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