Sprecher
Dr Hans Bäumler, CC-Ery GmbH /Charité-Universitätsmedizin Berlin
Alexander Bernhardt, Evonik Nutrition & Care GmbH
Prof Susanne Bremer- Hoffmann, Joint Research Centre (JRC) of the European Commission
Prof Dagmar Fischer, Universität Jena
Dr Svetlana Gelperina, Drugs Technology LLC
Dr Aaron Krueger, KBI Biopharma
Dr Marco Marenchino, Malvern Panalytical GmbH
Dr Margareth R. C. Marques, USP
Dr Lutz Müller, Dr. Regenold GmbH
James Nolan, Kyn Biopharmaceuticals
Prof. Ana Proykova, Faculty of Physics, University of Sofia
Dr Johannes Reich, Microcoat Biotechnology GmbH
Dr Tobias Schulz, Rittershaus Attorneys
Dr René Thürmer, BfArM, Federal Institute for Drugs and Medical Devices
Dr Emre Türeli, MJR Pharmjet GmbH
Dr Matthias G. Wacker, Fraunhofer IME
Dr Sylvia Wagner, IBMT
Dr Xiaoming Xu, U.S. FDA
Zielsetzung
This conference covers the legal and scientific aspects in the development of nanopharmaceuticals, medical devices and other products containing nanomaterials:
- Physicochemical characterization and quality aspects of nanopharmaceuticals
- Requirements from authority’s perspective
- Experiences from submissions and consequences for pharmaceutical development and lifecycle management
- Scientific data in regulatory submissions
Take advantage to discuss with colleagues from pharmaceutical industry, key opinion leaders from academia, manufacturers and authorities.
Hintergrund
In recent years, nanotechnology has become increasingly important for global industries. Nanopharmaceuticals and medical devices take advantage of advanced manufacturing technology and functionalized biomaterials. However, in some cases, nanomaterials may exert unexpected risks for human health and the environment.
In the light of the ongoing controversy, the use of nanomaterials and novel technologies in the pharmaceutical formulation pipeline will be presented. Furthermore, case examples for market applications will be presented and the effect of a growing regulatory framework on market perspectives will be highlighted.
The comprehensive program of the workshop will address these pressing concerns over how to develop novel nanoproducts, how to characterize them for submission or registration and how to deal with safety concerns
Zielgruppe
This seminar addresses pharmaceutical professionals in R&D as well as in quality control, production of pharmaceutical industry and excipient manufacturers.
Programm
Module 1: Background and Legal Challenges
Introduction to Nanomaterials
- 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
USP Perspectives for Drug Products Containing Nanomaterials
- 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
Regulations in the Area of advanced Engineered Nanomaterials
- 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
Quality Requirements on IMPD and Module 3 for particular Systems
- 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
Case Study: GMP Manufacturing of parenteral Nanoparticles using MicroJet Reactor Technology
- 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
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