24-26 September 2024, Lisbon/Porto Salvo, Portugal
Course No. 20937
Speakers
Dr Harald Stahl
Romaco
Objectives
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.
Background
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
Target Group
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, 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
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: 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 Sanofi: Spray Drying of Biologics
Biologics react very sensitive the stress of spray drying in most cases. In this case study, systematic investigations of the various stresses to which the drug substances are exposed are presented. Adequate formulation is able to solve most aggregation issues.
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
This course is part of the GMP Certification Programme "ECA Certified Technical Operations Manager" Learn more
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Seminar Programme as PDF