Host Cell Proteins - Live Online Training

Thursday, 18 April 2024 13.00 - 18.00 h

Seminar-Nr. 21271


Dr. Olaf Stamm

Dr. Olaf Stamm

Charles River Laboratories Germany

Dr. Jörg Engelbergs

Dr. Jörg Engelbergs


Erika Friedl

Erika Friedl


Florian Semmelmann

Florian Semmelmann

Roche Diagnostics

Dr. Marlen Kochte

Dr. Marlen Kochte

IDT Biologika

Thomas Flad

Thomas Flad


All times mentioned are CEST.


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.


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.
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 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.


Host Cell Proteins - Live Online Training

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

ECA-Member*: € 690,-
Regular Fee*: € 790,-
EU/GMP Inspectorates*: € 395,-
APIC Member Discount*: € 740,-

Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.

* auch unkompliziert per Kreditkarte bezahlbar
American Express Visa Mastercard

Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
Aufzeichnung nicht verfügbar

Haben Sie noch Fragen?

Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
Tel.: +49 6221 84 44 0
E-Mail: info@concept-heidelberg.de

Frau mit Headset


Teilnehmerstimmen - das sagen andere über unsere Seminare:

Guter, breit gefächerter Überblick mit interessanten Verknüpfungen zur Praxis,
welche die Theorie super veranschaulicht.”
Marina Kicoranovic, Labor Hartmann GmbH
GMP/Basis-Einstiegsschulung (B 14), September 2023

Die Referenten waren sehr gut! Sie haben sehr klar gesprochen, nur sehr wenige englische Begriffe
verwendet (super) und waren sehr praxisbezogen.”
Astrid Gießler, Regierungspräsidium Karlsruhe
Live Online Seminar - Basiskurs Computervalidierung & Datenintegrität im GxP Umfeld (B 3), Juni 2023

Sehr guter Bezug zur Schulung für einen GMP-Anfänger. Habe mich sehr gut abgeholt gefühlt.”
Dr. Harald Werner, Infraserv GmbH & Co. Höchst KG
GMP-Basisschulung (B 1), Juni 2023


Bleiben Sie informiert mit dem GMP Newsletter von Concept Heidelberg!

GMP Newsletter

Concept Heidelberg bietet verschieden GMP Newsletter die Sie auf Ihren Bedarf hin zusammenstellen können.

Hier können Sie sich kostenfrei registrieren.


Kontaktieren Sie uns

Haben Sie Fragen?

Concept Heidelberg GmbH
Rischerstraße 8
69123 Heidelberg

Tel. :+49622184440
Fax : +49 6221 84 44 84
E-Mail: info@concept-heidelberg.de

zum Kontaktformular