Highlights � Fundamentals of Spray Drying

� Development of a Spray Drying Process

� Advanced Characterization of Spray Dried Particles

� Scale Up of a Pharmaceutical Spray Drying Processes

� Validation of Spray Drying Processes in a CGMP Environment

� Manufacturing Technologies for Amorphous Solutions

� Aseptic Spray Drying

� Tailoring Spray Drying Processes for Biopharmaceutical and Respiratory Formulations

� Case Studies from Pharmaceutical Industry:

� Sanofi : Spray Drying of Biologics

� Roche: Spray Drying of highly active Substances

� Hovione: Amorphous Solid Dispersions by Spray Drying

Speakers

Dr Sune Klint Andersen Janssen Pharmaceutica

Dr Jean-René Authelin Sanofi

Dr Rainer Nicolai F. Hoff mann La-Roche

Simon Phillips Nova Laboratories

Dr João Pires Hovione

Dr Th omas Quinten Janssen Pharmaceutica

Dr Inês Ramos Hovione

Dr Harald Stahl GEA

Dr João Vicente Hovione

Dr Ann-Cathrin Willmann Boehringer Ingelheim Pharma

Spray Drying Solutions for the Pharmaceutical Industry

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

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Programme

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 dry- ing yourself. You will learn how the spray drying result is affect- ed 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 re- garding particle size distribution, residual moisture/solvent con- tent, bulk density and morphology.

One advantage of spray drying is the remarkable versatility of the technology, evident when analyzing the multiple applica- tions 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 pro- ducts and the potential for one-step formulations, spray drying offers multiple opportunities that no other single drying techno- logy 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 Audience This conference addresses specialists and executives working in the fields of pharmaceutical manufacture, research and develop- ment 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 dos- age forms for oral or pulmonary administration.

Moderator Dr Harald Stahl, GEA

Programme 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 pharma- ceutical 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/ agglo- meration processes more common in the pharma industry. A systematic approach for development of products/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 ro- bust process understanding to control the products properties. The scope of this talk is to describe the knowledge and risk-ba- sed methodology that guides the stages from the process design up to qualification and commercial phase of a spray drying ma- nufacturing process. The lecture will focus on predictive tools used to support process/product development and scale-up ac- tivities.

Spray Drying | 24-26 September 2024, Lisbon/Porto Salvo, Portugal

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 strate- gy to improve the bioavailability of poorly water-soluble drugs. ASD formulation typically requires the definition of multiple fac- tors that can amount to extensive lab experimentation, hinde- ring fast-to-market. This lecture will provide an overview of how to design a successful formulation for amorphous solid dispersi- ons 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 methodo- logy, 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 Biopharmaceu- tical 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 commer- cial production

� Optimisation of the spray drying process - overall product quality - lowest risk - shortest time to market

Case Study Sanofi: Spray Drying of Biologics

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 alterna-

tive 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 prece- ding 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

26 September 2024 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

Spray Drying | 24-26 September 2024, Lisbon/Porto Salvo, Portugal

Social Event On Tuesday 24 September you are cordially invited to a social

event. Th is is an excellent opportunity to share your experiences with colleagues from other companies in a relaxed atmosphere.

Speakers Dr Sune Klint Andersen, Janssen Pharmaceutica Sune gained his PhD in Particle Technology and has an MBA in Management & Technology. He worked for Niro

A/S for seven and for Novo Nordisk for 10 years as spray drying specia- list. Now he is working at Janssen Research & Development, Belgium as principal scientist in spray drying and particle engineering.

Dr Jean-René Authelin, Sanofi Jean René Authelin joined Rhone Poulenc in 1988 as a Chemical Engineer. In the 90’s he founded the Physical Quality function, dedicated to the API crystallization, dry-

ing, polymorphism, particle engineering for which he was for 10 years Global Head in Rhone Poulenc Rorer (now Sanofi ). Later he became Global Head of Pharmaceutical Engineering, now he is Senior Scientifi c Advisor, global CMC.

Dr Rainer Nicolai, F. Hoff mann La-Roche Rainer Nicolai has been involved in the handling of high purity and high activity substances since 1998. With a total of 15 years of experience as a project manager and contain-

ment expert at Roche, he is involved in a wide range of issues with high practical relevance.

Simon Phillips, Nova Laboratories As Head of Sterile Manufacturing at Nova Laboratories, Simon is responsible for all aspects of a Nova’s Sterile Con- tract Manufacturing business, including manufacturing in

three sterile manufacturing facilities, technical operations and business development. He and his teams are responsible for manufacture of both clinical and commercial sterile products fi lled in a range of presenta- tions.

Dr João Pires, Hovione João Pires obtained his PhD degree in the fi eld of Enginee- ring Design and Advanced Manufacturing. In 2018, he joined Hovione as a Drug Product Development Scientist.

Since 2021, he has been working as R&D Manager, leading the Process Development team in the Inhalation and Advanced Drug Delivery group, which focus on the process development and industrialization of tech- nologies such as spray drying, jet milling, wet polishing and microfl ui- dics.

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Dr Thomas Quinten, Janssen Pharmaceutica Thomas is a pharmacist with a PhD in Pharmaceutical Technology. He works a Senior Scientist for J&J in the De-

velopment of Oral Solid Dosage forms.

Dr Inês Ramos, Hovione Inês Ramos is R&D Manager/Scientist for Formulation in Oral Drug Product Development. Her core expertise inclu- des preformulation, ASD formulation, spray drying and ta-

bleting process development. Inês has an academic background in Pharmaceutical Sciences, holding a PhD degree in the same field on the development of green immunoanalytical methods using miniaturized fluidic devices.

Dr Harald Stahl, GEA Dr Harald Stahl worked in the Pharmaceutical Develop- ment of Schering AG in Germany. At that time his main in- terest was the aseptic production of pellets. Since 1995 he

served within GEA Process Technology in various positions. Presently he owns the position of a Group Director Application & Strategy Ma- nagement of GEA. He has published more than 20 papers on various aspects of pharmaceutical production.

Dr Joao Vicente, Hovione João Vicente has an academic background in Chemical En- gineering, holding a Masters in Biological Engineering and a Ph. D. in Pharmaceutical Technology. Over the last 15 ye-

ars, João has been focused on the development of tools and scale-up methods to expedite process development. João Vicente has been wor- king at Hovione R&D in the Drug Product Development Department and has participated in the Development and Qualification of several spray drying manufacturing processes. More recently João has been re- sponsible for the continuous improvement and post-approval changes throughout the commercial stage of the product’s life-cycle.

Dr Ann-Cathrin Willmann, Boehringer Ingelheim Pharma Ann-Cathrin Willmann is a pharmacist by training and holds a PhD in Pharmaceutical Technology focusing on

particle engineering for respiratory drug delivery. She works as Senior Scientist in Pharmaceutical Development at Boehringer Ingelheim, Ger- many.

Date Tuesday, 24 September 2024, 13.00 to approx 17.45 h, (Registration and coffee 12.30 – 13.00 h) Wednesday 25 September 2024, 08.30 to approx 17.15 h Thursday 26 September 2024, 8.30 to approx. 16.001/16.302/17.003 h)

1 approx. end of the site visit 2 approx. airport arrival 3 approx. return at the conference hotel

There will be a shuttle after the site visit. This shuttle will arrive at the airport at approx. 16.30 h and approx. at 17.00 at the hotel.

In certain cases a participation in the site visit may not be pos- sible due to competitive reasons. Participants are required to sign a Confidential Disclosure

Agreement (CDA) before entering Hovione sites

Venue TD Hotels Lagoas Park Lagoas Park, Edíficio 2, 2º Piso 2740-265 Porto Salvo Portugal Phone +351 21 791 2499 email: lagoaspark@tdhotels.com

Fees (per delegate, plus VAT) ECA Members EUR 2090.- per delegate plus VAT APIC Members EUR 2190.- per delegate plus VAT, (does not include ECA Membership) Non-ECA Members EUR 2290.- per delegate plus VAT EU GMP Inspectorates EUR 1145.- per delegate plus VAT The conference fee is payable in advance after receipt of invoice and includes conference documentation, dinner on 24 September, lunch on 25 September and a business lunch on 26 September and all refresh- ments. VAT is reclaimable.

Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms in the conference hotel. You will receive a room reservation

form/POG when you have registered for the course. Reserva- tion should be made directly with the hotel. Early reservation is recommended.

Registration Via the attached reservation form, by e-mail or by fax message. Or you register online at www.gmp-compliance.org.

Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materi- als will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automati- cally receive your certificate of participation.

Conference language The official conference language will be English.

Organisation and Contact ECA has entrusted Concept Heidelberg with the organisation of this event.

CONCEPT HEIDELBERG P.O. Box 10 17 64 D-69007 Heidelberg Phone +49(0)6221/84 44-0 Fax 49(0)6221/84 44 34 Email: info@concept-heidelberg.de www.concept-heidelberg.com

For questions regarding content please contact: Dr Robert Eicher (Operations Director) at +49(0)6221 / 84 44 12, or per e-mail at eicher@concept-heidelberg.de

For questions regarding organisation please contact: Mr Ronny Strohwald (Organisation Manager) at +49(0)6221/84 44 51, or per e-mail at strohwald@concept-heidelberg.de