Dr. Olaf Stamm
Charles River Laboratories Germany
Referent:innen
Dr. Jörg Engelbergs
Paul-Ehrlich-Institut
Erika Friedl
Paul-Ehrlich-Institut
Florian Semmelmann
Roche Diagnostics
Dr. Marlen Kochte
IDT Biologika
Thomas Flad
ProtaGene
All times mentioned are CEST.
Zielsetzung
In this Live Online Training, on the one hand, you will be familiarized with the current regulatory requirements for various product groups, and on the other hand, experts from authorities, laboratories and industry will give you an insight into the current state of science and technology and an insight into methods and strategy.
Hintergrund
The fact that pharmaceutical products must be free of impurities has long been undisputed. Particulate impurities have hit the headlines several times in recent years.
But with the increasing number of biopharmaceutical products, including those based on recombinant proteins, the importance of protein-based impurities has also increased. As a rule, host organisms ranging from yeast to E.coli and CHO (Chinese Hamster Ovary) cell lines serve as producers of the recombinant proteins.
From these host cells, own proteins can appear as impurities of the active substance or the drug. These are grouped together as HCPs.
But with the increasing number of biopharmaceutical products, including those based on recombinant proteins, the importance of protein-based impurities has also increased. As a rule, host organisms ranging from yeast to E.coli and CHO (Chinese Hamster Ovary) cell lines serve as producers of the recombinant proteins.
From these host cells, own proteins can appear as impurities of the active substance or the drug. These are grouped together as HCPs.
Host cell proteins (HCPs) are an inevitable impurity of biopharmaceuticals, regardless of whether they are produced by recombinant fermentation or extracted from natural sources. Even after multiple sophisticated purification steps, HCPs remain or copurify with product. Host Cell Proteins represent a heterogeneous variety of different proteins that need to be quantified in the drug substance and in intermediates from the downstream purification process. The risk for adverse effects, such as immunogenic reaction, does not necessarily correlate with the amount of certain host cell proteins, and even small traces of certain HCPs can be highly immunogenic.
The heterogeneity of the HCPs requires a thorough control regime and sophisticated assays for detection and quantitation in various samples matrices. Historically, immunoassays using polyclonal antibodies have been used for process development, validation, and release testing. However, with the advance in Mass Spectrometry, new orthogonal tools for identification and quantitation became available which help to gain a deep understanding of the HCP composition at various stages of the purification process and in the drug substance.
The heterogeneity of the HCPs requires a thorough control regime and sophisticated assays for detection and quantitation in various samples matrices. Historically, immunoassays using polyclonal antibodies have been used for process development, validation, and release testing. However, with the advance in Mass Spectrometry, new orthogonal tools for identification and quantitation became available which help to gain a deep understanding of the HCP composition at various stages of the purification process and in the drug substance.
Zielgruppe
The course is intended for all persons from
- pharmaceutical manufacturers
- active ingredient producers
- regulatory and registration authorities
- contract laboratories
- research institutions
who deal with the problem of HCPs.
Technical Requirements
We use WebEx Events for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
General Regulatory-Scientific Requirements for HCP Assessment and Specifities for Monoclonal Antibodies
- Safety considerations for HCP
- Process capacity for HCP removal
- HCP control strategy during clinical development
- Aspects for assay development: Characterisation of coverage rate and expectations on process specific assays
A Holistic View on Traditional and New Tools to Address the HCP Challenge
- Assays concepts: Generic-Platform-Project Specific
- Optimized strategies for generation of multi-analyte antibodies
- Qualification of assay reagents using orthogonal methods
Blood Product Specific Regulatory Requirements with HCP Case Studies
- Assay suitability (Process-specific assays versus generic assays)
- Setting appropriate specifications
- Life cycle management of HCP assays
- Problematic HCPs (identification and removal)
HCP Assessment in Vaccine Products
- Challenges of contract manufacturing of vaccines: Facing a broad spectrum of HCPs from different production cell lines and diverse matrix effects from different production processes
- Development of a platform DF-1 HCP-ELISA for MVA vector-based vaccines
Controlling Host Cell Impurities in Biopharmaceuticals
- Characterization strategy for HCP
- Limitations of common immunoassays
- Orthogonal methods
The Increasing Role of Mass Spectrometry (MS) within HCP Control Strategies
- MS for support of USP and DSP optimization
- Specificity coverage analysis by IAC-MS
- Summary and outlook
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