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Spray Drying

24-26 September 2024, Lisbon/Porto Salvo, Portugal

Seminar-Nr. 20937

Referent:innen

Dr Harald Stahl

Dr Harald Stahl

GEA

Dr Sune Klint Andersen

Dr Sune Klint Andersen

Janssen Pharmaceutica

Dr Rainer Nicolai

Dr Rainer Nicolai

F. Hoffmann-La Roche

Dr João Vicente

Dr João Vicente

Hovione FarmaCiencia

Thomas Quinten

Thomas Quinten

Janssen Pharmaceutica

Dr Ann-Cathrin Willmann

Dr Ann-Cathrin Willmann

Boehringer Ingelheim Pharma

Dr.Inês Ramos

Dr.Inês Ramos

Hovione FarmaCiencia

Dr. João Pires

Dr. João Pires

Hovione FarmaCiencia

Jesper Jensen

Jesper Jensen

Novo Nordisk

Simon Phillips

Simon Phillips

Nova Laboratories

Zielsetzung

Take advantage of the opportunity to focus on spray drying technology and process and get a first hand demonstration of solutions for diverse requirements. Further, benefit from the site visit where you can get a hands-on experience in spray drying yourself. You will learn how the spray drying result is affected by different equipment, parameter changes etc.

Hintergrund

Spray drying is presently one of the most exciting Technologies for the pharmaceutical industry, being an ideal process where the end-product must comply with precise quality standards regarding particle size distribution, residual moisture/solvent content, bulk density and morphology.
One advantage of spray drying is the remarkable versatility of the technology, evident when analyzing the multiple applications and the wide range of products that can be obtained. From very fine particles for pulmonary delivery to big agglomerated powders for oral dosages, from amorphous to crystalline products and the potential for one-step formulations, spray drying offers multiple opportunities that no other single drying Technology can claim.
 
Benefits of Spray Drying
  • High precision control over:
    • Particle size
    • Bulk Density
    • Degree of crystallinity
    • OVIs and residual solvents
  • Typical application in pre-formulated products
    • Microencapsulations
    • Solid Solutions
    • Improved bioavailability and stability
  • For products with unusual or difficult characteristics
    • Sticky or hygroscopic products
    • Slowly crystallizing products
    • Difficult to isolate products
  • Rapid drying for temperature sensitive materials

Zielgruppe

This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and development and quality control as well as technicians, planners and plant designers, especially those involved with the manufacture of powders and granules, as e.g. in the manufacture of solid dosage forms for oral or pulmonary administration.

Visit of the Hovione Spray Drying Facilities in Lisbon

As part of the conference you will have a unique opportunity to visit Hovione's labs and manufacturing facilities in Lisbon, where research, development and manufacturing activities take place. In the labs you will gain access to Particle Engineering facilities, explore some of the most advanced analytical PAT tools, and get
a close look at the specialized equipment used in spray drying development. You will also have the chance to observe analytical and process development operations in an engaging hands-on workshop, guided by Hovione experts.
During the visit to the manufacturing facilities, you will witness a state-of-the-art facility in action, showcasing a commercial spray drying unit.
Please note that availability for this exclusive site visit is limited, so securing your spot early is highly recommended to ensure you don't miss out on this opportunity to experience Pharmaceutical innovation at Hovione.
  • We provide bus transfer from the conference hotel to the Hovione sites. After the site visit there will be transfers to the airport and back to the conference hotel
  • Due to competition reasons, individual participants may be excluded from the site visit
  • Participants are required to sign a Confidential Disclosure Agreement (CDA) before entering Hovione sites

Programm

Spray Drying

Gesamtes Programm als PDF herunterladen

Fundamentals of Spray Drying
  • Identification of Critical Process Parameters
  • Control of those Process Parameters
  • Influence of these Process Parameters on Product Quality
  • Example of setting up a Spray Drying Process
Development of a Spray Drying Process
  • Scientific Basics
  • Lab Equipment
  • Material selection
  • Scaleability
  • Design of the test series
  • Case studies
    • Dry powder for Inhalation
    • Amorphous solid dispersions
Advances in Characterization of Morphology of spray dried Particles
  • Elucidation of spray drying particle microstructure like wall thickness, porosity
  • Application of Tomography and FIB-SEM
  • Application of Machine Learning/AI to subdivide particles in morphology classes
  • Impact of this new knowledge on formulation and process development
Development of Scaleable Spray Drying Processes for Solid Drug Product Manufacture
The presentation starts from the target properties of Pharmaceutical intermediates and products for oral solid dosage forms and for dry powder inhalation, viewing SD as a particle design tool. Examples of various product types, such as amorphous drug substances, solid dispersions, granulates and inhalable powder, are given. SD is then compared to other drying/ Agglomeration processes more common in the pharma industry. A systematic approach for development of  roducts/processes by means of spray drying is illustrated. A special focus is given to the scaleability of the SD processes.
 
Scale-up of a Spray Drying Process
A spray drying process will be subjected to multiple Scale-up steps throughout the product’s life-cycle, thus requiring a robust process understanding to control the products properties. The scope of this talk is to describe the knowledge and risk-based methodology that guides the stages from the process design up to ualification and commercial phase of a spray drying manufacturing process. The lecture will focus on predictive tools used to support process/product development and scale-up activities.
 
Amorphous Solid Dispersions – Manufacturing Technologies
  • Amorphous solid dispersions: a way to improve the aqueous solubility and oral bioavailability
  • Spray drying from lab scale to commercial scale: end to end process development
  • Case study: upscaling form lab scale equipment to commercial scale equipment
Amorphous solid Dispersions by Spray Drying from a Formulation Perspective
The manufacturing of Amorphous solid dispersions (ASD) has become an established and commercially demonstrated strategy to improve the bioavailability of poorly water-soluble drugs. ASD formulation typically requires the definition of multiple factors that can amount to extensive lab experimentation, hindering fast-to-market. This lecture will provide an overview of how to design a successful formulation for amorphous solid dispersions produced by spray drying, using a streamlined approach and a proprietary technology to expedite the screening phase with minimal API requirements. An overview of Hovione’s methodology, the evaluation process, and the studies typically utilized, insights on alternative excipients, as well as key Information needed to make a formal assessment of the best candidates will be provided resorting to case studies.
 
Validation of Spray Drying Processes
  • Development of spray drying process using Quality-by-Design
    • Design of Experiments (DoE)
    • Critical Process Parameters
    • Critical Material Attributes
  • Risk assessments:
    • Spray Drying Process
    • Spray Dryer Design
  • Qualification and Validation of a Spray Dryer
  • Process Validation
    • Scale-up
    • Control Strategy
  • Special tests during qualification and validation
Tailoring Spray Drying Processes for Biopharmaceutical and Respiratory Formulations
  • Requirements & challenges when applying spray drying for biopharmaceutical and respiratory products
  • Adaptation of specifications and de-risking of the process during its development from laboratory scale to commercial production
  • Optimisation of the spray drying process
    • overall product Quality
    • lowest Risk
    • shortest time to market
Case Study NovoNordisk: Spray Drying of Biopharmaceuticals
 
Aseptic Spray Drying as an enabling Technology for novel Sterile Presentations
  • Sterile Processing and Isolator Technology
  • Aseptic validation and sterility assurance
  • Aseptic spray drying as stabilisation platform and alternative to aseptic Lyophilisation
  • Sterile finished drug product presentations based on sterile spray dried powder
  • Emerging trends and case studies
Case Study Roche: Spray Drying of highly active Substances
  • Large scale containment Technologies
  • Operating conditions versus Containment
  • Cleanability in regard to containment performance
Trouble Shooting Session
In this interactive session, all the key elements of the preceding lectures are brought together. What to do if:
  • Particles are to fine/coarse
  • Yield is too low
  • Final product moisture content is to high
  • Different product characteristics after scale up

ECA-Member*: € 2090,-
Non ECA Member*: € 2290,-
EU/GMP Inspectorates*: € 1145,-
APIC Member Discount*: € 2190,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

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