2nd Annual Pharmaceutical Lyophilization Summit 2020

Tentative Schedule:

08:00 Registration and Welcome Coffee

08:30 Opening Address from the Chairman

08:40 Workshop: Use of refrigereants in Freeze Dryers – Discussion and impact of current solutions.

• Overview of refrigeration concepts
• Development of common refrigerants and specific environmental impact
• Comparison of energy efficiency of refrigeration principes
• Energy consumption of a Lyophilization cycle and resulting CO2 emission – with examples of existing installations and lyo-cycles
• Outlook of future refrigeration development
• Refitting the refrigeration system and Impact on cycle validation

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

09:40 Speed Networking

10:20 You don´t need to be great to start, but you need to start to be great – A pilot on multivariate monitoring for a lyophilized Product.

• Multivariate monitoring for Fill and Finish
• Challenges and roadblocks
• Future plans

Michael Dekner,
Innovation & External Collaborations, Takeda, Austria

11:00 Morning coffee and networking break

11:30 Crystallization during freezing and drying: practical importance and characterization methods.

• Many excipients and active pharmaceutical ingredients can crystallize during freezing and freeze-drying
• Crystallization behavior depends on multiple factors, e.g., the nature of a particular molecule, presence and concentration of other solutes, and freezing/annealing conditions
• Crystallization can be either beneficial (e.g., bulking agent), or detrimental (e.g., cryo/lyoprotector) for manufacturing process efficiency and the product quality
• Analytical methods to monitor crystallization on both small scale (e.g., DSC and low-temperature X-ray diffraction) and in-situ during manufacture (e.g., heat flux sensors) are discussed

Dr. Evgenyi Shalaev,
Executive Director, Allergan, Irvine, California, USA

12:10 Z-FDM : A new instrument combining impedance spectroscopy with a freeze drying microscope.

• Theory: broad band dielectric relaxation spectroscopy of frozen solutions
• Z-FDM: A description of the new measurement system
• Applications in freezing (nucleation temperature, ice growth rates, solidification end point)
• Applications in primary drying (drying rate, product collapse)
• Future applications for high throughput screening (concurrent product and process design)

Prof. Geoff Smith,
Professor of Pharmaceutical Process Analytical Technology, De Montfort University, Leicester, United Kingdom

12:50 Business lunch

14:00 Considerations to Freeze-Dry Concentrated Protein Solutions

• 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

14:40 Development of a lyophilised protein product using a QbD approach.

The presentation will describe a case study about the product and process development of a freeze dried protein product. The different phases from formulation to cycle optimisation and technology transfer will be covered, highlighting challenges and commercial benefits.

• Case study: lyophilised protein product
• Pre- and post- product characterisation
• QbD approach

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

15:10 Afternoon coffee and networking break

15:40 Electrospinning of Biopharmaceuticals.

• Challenges in drying of biopharmaceuticals
• Electrohydrodynamic drying methods
• Morphology and size control
• Formulation considerations for electrospinning

Dr. Sune Klint Andersen,
Principal Scientist DPD – Oral Solid Dosage, Janssen, Antwerp, Belgium

16:20 Impact of Freeze-Drying Conditions on the Stability of Protein-Sugar Formulations.

• Vapor sorption techniques (DVS) have proven to be valuable techniques for studying the impact of lyophilization conditions on stability of food and pharmaceutical materials
• DVS proves to be an extremely sensitive technique for the investigation of protein-sugar interactions and the determination of moisture-induced phase transitions
• DVS can be used to characterize crystalline and disordered materials including polymorphs, hydrates, defect sites, and amorphous materials
• The unique information accessed through DVS and IGC SEA experiments can add important insight for characterizing and developing solid pharmaceutical materials

Rameez Ahmad,
Sales and Business Development Manager, Surface Measurement Systems, Erlangen, Germany

17:00 Panel Discussion

• Characterization of freeze-dried formulations;
• Controlled ice nucleation in clinical and commercial manufacture;
• Controlled nucleation does it hold up to its promises?
• Practical use of primary drying modeling;
• Continuous freeze-drying versus batch freeze-drying;
• Will continuous manufacturing approaches of the future be the reserve of small scale batches (e.g. for personalized medicines) or could it also serve as a replacement for large scale batch manufacturing;
• What is the current need/demand for process understanding (inc. process analytical technologies) in the framework of these new continuous manufacturing methods?
• Optimization of PAT tools and impact on cycle validation;
• New regulatory requirements to media fill (Aseptic Simulation) and impact on equipment qualification;
• Is the cleaning validation performed product specific or via lead substance?
• Or if no cleaning verification has been carried out so far?
• How are the stoppers treated after sterilization. What is the moisture content of the stoppers before freeze-drying

17:50 Chairman’s closing remarks and end of day one

19:00 Business dinner