On-demand webinar: Navigating CMC requirements for Spray Drying Processes

On-demand webinar: Navigating CMC requirements for Spray Drying Processes

Spray drying is a continuous, reproducible, cost-effective and scalable process for the production of stable amorphous solid dispersions.
This technology enables the production of dry pharmaceutical powders for tablets, powder-filled capsules and inhaled drug products.
The dispersion of a drug in a polymer matrix results in enhanced solubility in intestinal fluids and improved bioavailability.

To enable rapid product development and file submission it is paramount to integrate CMC strategies and regulatory aspects early in the drug product development process.
CMC demands are growing throughout the clinical phases and they require phase appropriate expertise and management skills.

This webinar will address key CMC challenges and integrated project management solutions for spray dried pharmaceutical product development.

Presenters
Stefano Console
Scientific Advisor
Stefano Console has more than 30 years of experience in the pharmaceutical and fine chemical business. The broad experience gained with different CDMOs coupled with an unceasing scientific curiosity for new technologies led Stefano to hold strategic roles managing a large number of successful projects for big as well as small Pharma partners across EU, USA and Japan. A vibrant passion for business development, organizational innovation and start-up initiatives, together with a relevant expertise in pharmaceutical particle engineering technologies (especially micronization and spray drying related technologies) and respiratory products complete the profile.
Currently Stefano is Senior Advisor and Founder at Oriento SA, Member of the Advisory Board at eu.reca (European Respiratory Cluster of Antwerp) and Scientific Advisor at Ardena.
Stefano received his five-year degree in Chemistry from the University of Milano, Italy.

Arno Vermote
Senior CMC Writer
Graduated in Pharmaceutical Sciences and having obtained a PhD in medicinal chemistry, he started his career as a medical writer for a Belgian CRO. Later he joined Ardena as a CMC Writer and rapidly grew to Senior CMC Writer. His role is to provide regulatory advice to clients as well as to write regulatory documentation for new chemical entities in clinical studies. Next to providing assistance and support to clients, he also fulfills a role in technical sales for the Ardena Dossier Development team. Having a background in medicinal chemistry and being a pharmacist by training, Arno combines knowledge and expertise in both drug substance and drug product development.

Latest resources

Our team members share deep, scientific understanding and insights into their respective fields of expertise.

See all
Microfluidization for Precision Nanoparticle Engineering
Expert Q&A

Microfluidization for Precision Nanoparticle Engineering

Read more
# Nanomedicine
Precision Polymorph Screening with Electron Diffraction
Application Note

Precision Polymorph Screening with Electron Diffraction

Read more
# Solid State
Chirality in drug development: from racemic mixtures to enantiopure substances
Insights

Chirality in drug development: from racemic mixtures to enantiopure substances

Read more
# Drug Substance Solid State
Defining acceptable impurity levels for drug substances in GLP toxicology studies
Insights

Defining acceptable impurity levels for drug substances in GLP toxicology studies

Read more
# Drug Substance
Enhancing Safety in Drug Substance Synthesis: A Smart Approach to Chemical Design
Insights

Enhancing Safety in Drug Substance Synthesis: A Smart Approach to Chemical Design

Read more
# Drug Substance
Insights into Thermogravimetric and Evolved Gas Analysis
Expert Q&A

Insights into Thermogravimetric and Evolved Gas Analysis

Read more
# Solid State
The importance of polymorph screenings
Whitepapers

The importance of polymorph screenings

Read more
# Solid State
How to save significantly on early-phase clinical supply logistics?
Insights

How to save significantly on early-phase clinical supply logistics?

Read more
# Clinical Supply
(Cross-)Contamination Control through Effective Equipment Cleaning
Whitepapers

(Cross-)Contamination Control through Effective Equipment Cleaning

Read more
# Drug Substance High potency & controlled substances
Your Premier Partner for API Synthesis and Purification Services
Info sheets

Your Premier Partner for API Synthesis and Purification Services

Read more
# Drug Substance Preparative HPLC
Solid State Chemistry and Strategic Outsourcing
Whitepapers

Solid State Chemistry and Strategic Outsourcing

Read more
# Solid State
Leading the Way in Nanomedicine Solutions
Info sheets

Leading the Way in Nanomedicine Solutions

Read more
# Nanomedicine
Design of Experiments (DoE) and its relevance in API crystallization process development
Expert Q&A

Design of Experiments (DoE) and its relevance in API crystallization process development

Read more
# Solid State
Preparative HPLC Excellence
Info sheets

Preparative HPLC Excellence

Read more
# Drug Substance Preparative HPLC
Dynamic Vapor Sorption (DVS) and its relevance in API characterization
Expert Q&A

Dynamic Vapor Sorption (DVS) and its relevance in API characterization

Read more
# Solid State
Streamlining Early Drug Development: Efficient Synthesis of Highly Potent Compounds
Whitepapers

Streamlining Early Drug Development: Efficient Synthesis of Highly Potent Compounds

Read more
# Drug Substance High potency & controlled substances
The importance of API Intrinsic Dissolution Rate and how to determine it
Expert Q&A

The importance of API Intrinsic Dissolution Rate and how to determine it

Read more
# Solid State
Understanding Highly Potent APIs and Safe Handling in Drug Development at Ardena
Expert Q&A

Understanding Highly Potent APIs and Safe Handling in Drug Development at Ardena

Read more
# Drug Substance High potency & controlled substances
A CDMO’s insight on amorphous solid dispersions
Expert Q&A

A CDMO’s insight on amorphous solid dispersions

Read more
# Drug Product
Accelerate Your Path to Preclinical Trials
Info sheets

Accelerate Your Path to Preclinical Trials

Read more
# Bioanalysis Drug Product
On-demand webinar: Breaking the Bioavailability Barrier: Formulation strategies for Improving API Solubility
Webinars

On-demand webinar: Breaking the Bioavailability Barrier: Formulation strategies for Improving API Solubility

Read more
# Bioavailability Enhancement Drug Product
On-demand webinar: Mastering Nanomedicines Characterization: Techniques for Determining Particle Size Distribution Based on Dynamic Light Scattering
Webinars

On-demand webinar: Mastering Nanomedicines Characterization: Techniques for Determining Particle Size Distribution Based on Dynamic Light Scattering

Read more
# Nanomedicine
On-demand webinar: Preparative HPLC for Purification of Pharmaceutical Compounds: Methodologies and Case Studies
Webinars

On-demand webinar: Preparative HPLC for Purification of Pharmaceutical Compounds: Methodologies and Case Studies

Read more
# Drug Substance Preparative HPLC
Exploring the Science and Technology Behind Fractionation, Purification, and Downstream Processing: From Discovery to Commercialization
Whitepapers

Exploring the Science and Technology Behind Fractionation, Purification, and Downstream Processing: From Discovery to Commercialization

Read more
# Drug Substance Preparative HPLC
On-demand webinar: Advancing Drug Development: Overcoming Bioanalytical Challenges of Nanomedicines and ADCs
Webinars

On-demand webinar: Advancing Drug Development: Overcoming Bioanalytical Challenges of Nanomedicines and ADCs

Read more
# Bioanalysis
On-demand webinar: Compatibility and In-Use Stability Studies for Injectables
Webinars

On-demand webinar: Compatibility and In-Use Stability Studies for Injectables

Read more
# CMC Regulatory Drug Product Injectable Drugs
Comparison of ELLA and Meso Scale Discovery V-Plex technologies for biomarker analysis
Expert Q&A

Comparison of ELLA and Meso Scale Discovery V-Plex technologies for biomarker analysis

Read more
# Bioanalysis
On-demand webinar: Navigating highly potent drugs to clinic: best practices from API to drug product
Webinars

On-demand webinar: Navigating highly potent drugs to clinic: best practices from API to drug product

Read more
# High potency & controlled substances
Using Flow Technology in Nanoparticle Synthesis
Expert Q&A

Using Flow Technology in Nanoparticle Synthesis

Read more
# Nanomedicine
Advancing oligonucleotide therapeutics with cutting-edge bioanalytics
Info sheets

Advancing oligonucleotide therapeutics with cutting-edge bioanalytics

Read more
# Bioanalysis Nanomedicine
Phase-appropriate analytical method development
Whitepapers

Phase-appropriate analytical method development

Read more
# Drug Product Drug Substance
On-demand webinar: Capsules, a versatile OSD for early phase development
Webinars

On-demand webinar: Capsules, a versatile OSD for early phase development

Read more
# Drug Product Oral Drugs
On-demand webinar: From Molecule To Patient: Phase-Appropriate API Development Strategies
Webinars

On-demand webinar: From Molecule To Patient: Phase-Appropriate API Development Strategies

Read more
# Drug Substance
Scientific/CMC Writing and Regulatory Support
Info sheets

Scientific/CMC Writing and Regulatory Support

Read more
# CMC Regulatory
Fill & Finish Services
Info sheets

Fill & Finish Services

Read more
# Drug Product Injectable Drugs
Driving your lead candidate to clinic
Info sheets

Driving your lead candidate to clinic

Read more
# Drug Product Drug Substance Solid State
Phase-appropriate drug substance manufacturing
Info sheets

Phase-appropriate drug substance manufacturing

Read more
# Drug Substance
Facilitating clinical trial success for drug products
Info sheets

Facilitating clinical trial success for drug products

Read more
# Drug Product Oral Drugs
Leading Bioanalytical Competencies
Info sheets

Leading Bioanalytical Competencies

Read more
# Bioanalysis
Excellence in solid state research
Info sheets

Excellence in solid state research

Read more
# Solid State
Drug substance for early clinical phase initiation – the underestimated risk of unexpected N‑nitrosamine impurities
Whitepapers

Drug substance for early clinical phase initiation – the underestimated risk of unexpected N‑nitrosamine impurities

Read more
# Drug Substance
Bioanalytical characterization and monitoring of ADCs supporting safety and efficacy from pre-clinical to clinical
Whitepapers

Bioanalytical characterization and monitoring of ADCs supporting safety and efficacy from pre-clinical to clinical

Read more
# Bioanalysis
Deciphering the complex characteristics of nanoparticles by asymmetric flow field-flow fractionation
Whitepapers

Deciphering the complex characteristics of nanoparticles by asymmetric flow field-flow fractionation

Read more
# Nanomedicine
Navigating the CMC Regulatory Landscape for Oligonucleotide Therapeutics
Info sheets

Navigating the CMC Regulatory Landscape for Oligonucleotide Therapeutics

Read more
# CMC Regulatory Nanomedicine
Phase-appropriate development of a phase 1 oral dosage form
Whitepapers

Phase-appropriate development of a phase 1 oral dosage form

Read more
# Drug Product
Strategies for Effective Cold Chain Packaging and Labelling
Expert Q&A

Strategies for Effective Cold Chain Packaging and Labelling

Read more
# Clinical Supply
Timely Clinical Trial Material Services
Info sheets

Timely Clinical Trial Material Services

Read more
# Clinical Supply
Leverage the power of CMC in early drug development
Whitepapers

Leverage the power of CMC in early drug development

Read more
# CMC Regulatory Drug Product Drug Substance
Formulation and Process Considerations for Optimising Spray-Dried Solid Dispersions
Whitepapers

Formulation and Process Considerations for Optimising Spray-Dried Solid Dispersions

Read more
# Bioavailability Enhancement Drug Product
Much more than just smoke - from marijuana to medicinal cannabis derived therapeutics
Whitepapers

Much more than just smoke - from marijuana to medicinal cannabis derived therapeutics

Read more
# CMC Regulatory Drug Product Drug Substance
Development of an assay to predict immunogenicity for an analogue of an endogenous protein
Case studies

Development of an assay to predict immunogenicity for an analogue of an endogenous protein

Read more
# Bioanalysis
Prevent undesired immunogenicity from becoming the barrier for innovative biotherapeutics
Whitepapers

Prevent undesired immunogenicity from becoming the barrier for innovative biotherapeutics

Read more
# Bioanalysis
Scientific Advice and Dialogue with EMA during Drug Development
Whitepapers

Scientific Advice and Dialogue with EMA during Drug Development

Read more
# CMC Regulatory
When to conduct a polymorph screening? Ardena’s phase-appropriate approach
Whitepapers

When to conduct a polymorph screening? Ardena’s phase-appropriate approach

Read more
# Solid State
Applying the science of advanced dissolution testing to accelerate product approval
Case studies

Applying the science of advanced dissolution testing to accelerate product approval

Read more
# Drug Product
Discriminatory dissolution test method in late development
Case studies

Discriminatory dissolution test method in late development

Read more
# Drug Product
Which solubility-enhancing technology should I use to support my early drug development project?
Whitepapers

Which solubility-enhancing technology should I use to support my early drug development project?

Read more
# Bioavailability Enhancement Drug Product
Powder blending in early-phase drug product development: Balancing art and science
Whitepapers

Powder blending in early-phase drug product development: Balancing art and science

Read more
# Drug Product
Oligonucleotide therapeutics: How to measure plasma concentration, tissue distribution and immunogenicity?
Whitepapers

Oligonucleotide therapeutics: How to measure plasma concentration, tissue distribution and immunogenicity?

Read more
# Bioanalysis

Want to hear more from Ardena?

Sign up to receive drug development insights, the latest on industry trends & Ardena news.

Stay up to date with our latest news and announcements.
Get deep, scientific understanding and insights into our key fields of expertise.
See the events we're attending and register for webinars we're hosting.