Nano and Micro Formulations - An ECA Academy, Loewe Center of Translational Medicine and Fraunhofer Institute for Molecular Biology and Applied Ecology (IME) JOINT CONFERENCE

Programme

Module 1: Background and Legal Challenges

• The complex nano landscape
• Challenges and pitfalls in the nano development
• Nanosafety: Real risk or inadequate experiments?

• Optimal conditions for extruding liposomes stability under different conditions
• Limit of detection for fluorescently labeled liposomes
• Charactization by Nanoparticle Tracking Analysis (NTA) and Dynamic and Electrophoretic Light Scattering
• Using the data for optimizations

• Introduction and general considerations
• The European legal framework for nanomaterials in medicinal products
• Nanomaterials according to the new EU-MDR 2017/745

• Particle characterization techniques can be applied across a wide variety of sample types
• Multiple particle techniques can be used to adequately characterize therapeutic products or nanomedicines and particle populations
• Advances in analytical technology for characterization and identification of particles provides a tremendous amount of new data
• Careful interpretation of data and in-depth understanding of the method limitations is of utmost importance for complementary methods

Module 2: Development and Characterization

• Nomenclature and definition of pharmaceutical dosage forms containing nanomaterials – Harmonization with the US FDA
• In-vitro release tests (dissolution/drug release)
• Physical-chemical characterization techniques

• Correlation between biological performance and quality attribute
• Identification and characterization of certain nanoparticle quality attributes
• Impact to efficacy
• Impact to safety of clinical stage product

• Nanomaterial definitions and considerations
• Drug products containing nanomaterials
• Physicochemical characterizations and performance testing for quality considerations

• PLGA nanoparticles, microparticles and liposomes
• Physicochemical characterization and drug release testing
• In vitro drug release testing using the dispersion releaser technology
• In vitro-in vivo correlation

• In vitro testing of nanomaterials
• In vitro/ ex vivo cell culture models
• In vitro testing panel

Module 3: Further Challenges for Nanopharmaceuticals and Medical Devices

• Behaviour of advanced engineered nano & micro particles
• Applications in phase changing and porous materials, polymers
• Micro/nano scale modelling of new materials
• Risk assessment of nano/micro materials usage

• Relevance of endotoxin testing in nanoparticle samples
• Common endotoxin test methods
• Interference of nanoparticles with common test methods
• Interaction of nanoparticles with endotoxin

• How the EU promotes the development of new nanomedicines by: Publishing guidance,
• Scientific advice, Convergence of scientific requirements to support the quality, safety and efficacy of nanomedicines
• Regulatory challenges deriving from the use of an innovative technology that crosses different platforms

• Introduction into the service and process
• Collaboration with regulators

• Overview RESOMER product portfolio for parenteral formulations
• FormEZE microencapsulation process
• Nanoparticulate dosage forms based on PLGA polymers

Module 4: Case Studies: Quality and Manufacturing

• Requirements for specific clinical phase
• Differences clinical studies versus marketing authorisation

• Nanoparticles for brain delivery: proof of the concept
• Preclinical studies
• Technological issues
• Clinical development

• Requirements for GMP manufacturing of nanoparticles
• Preparation of nanoparticles with precipitation using MicroJet Reactor Technology
• Validation of nanoparticle manufacturing method using MicroJet Reactor Technology
• Downstream processing of nanoparticles
• In process controls for nanoparticle manufacturing