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Mass Spectrometry - A powerful tool box for Host Cell Protein analysis 2017 Poster

Developing and producing recombinant biopharmaceuticals in mammalian cells requires unambiguous monitoring of HCPs impurities. Immunoassays are still the method of choice for release testing, for which it is recommended to demonstrate the suitability of antisera in a QM-regulated environment to meet regulatory demands. However, peptide analysis by MS has been proven to be a powerful tool by providing complementary data for HCP characterization.

Domain specific N-glycan profiling of a Fc-fusion antibody 2016 Poster

The development and production of recombinant biopharmaceuticals and their biosimilars
is a challenging field due to their structural complexity. While demonstrating batch to batch
comparability is a demanding analytical task, demonstrating biosimilarity is even more
challenging as it is already performed during early development with limited knowledge of
the structural features of the biosimilar candidate and limited molecule specific method
experience. Additionally analytical methods in biosimilar development need to be applied
for different aspects…

Mass Spectrometry: A powerful tool for Host Cell Protein analysis Poster

Developing and producing recombinant biopharmaceuticals in mammalian cells requires unambiguous monitoring of HCPs impurities. Immunoassays are still the method of choice
for release testing, for which it is recommended to demonstrate the suitability of antisera in a
QM-regulated environment to meet regulatory demands. However, peptide analysis by MS has been proven to be a powerful tool by providing complementary data for HCP characterization.

In Vivo Attribute Quantitation and PK Modeling mAbs 2016 Scientific Paper

A thorough understanding of drug metabolism and disposition can aid in the assessment of efficacy and safety.
However, analytical methods used in pharmacokinetics (PK) studies of protein therapeutics are usually based on
ELISA, and therefore can provide a limited perspective on the quality of the drug in concentration
measurements. Individual post-translational modifications (PTMs) of protein therapeutics are rarely considered
for PK analysis, partly because it is technically difficult to recover and quantify individual protein variants from
biological…

In Vivo Assessments of Quality Attributes mAbs 2016 Scientific Paper

Characterization of biopharmaceutical proteins and assessment and understanding of the critical
quality attributes (CQAs) is a significant part of biopharmaceutical product development and is routinely
performed in vitro. In contrast, systematic analysis of the quality attributes in vivo is not as widespread,
although metabolism and clearance of multiple variants of therapeutic proteins administered to nonhuman
primates and human subjects may have a different impact on safety, efficacy and exposure. The
major hurdles of such studies are usually sample…

Analytical support in cell line- and process development for achieving biosimilarity 2015 Poster

The development of biosimilars is a challenging field due to the need of achieving highest similarity to a structural highly complex molecule. The establishment and development of a high
productive and robust production process represents a challenging and critical path prior to the biosimilar comparability demonstration. When implementing a process for the synthesis of
new biological entities (NBE) or biosimilars, variations in the protein structure or post-translational modifications can occur. A subset of qualified and robust analytical methods are
required to monitor…

Challenges of Demonstrating Biosimilarity 2015 Poster

The development and production of recombinant biopharmaceuticals and their biosimilars
is a challenging field due to their structural complexity. While demonstrating batch to batch
comparability is a demanding analytical task, demonstrating biosimilarity is even more
challenging as it is already performed during early development with limited knowledge of
the structural features of the biosimilar candidate and limited molecule specific method
experience. Additionally analytical methods in biosimilar development need to be applied
for different aspects…

Characterization of HCP antiserum and detection of HCPs by 2D gel electrophoresis 2015 Poster

Developing and producing recombinant biopharmaceuticals in mammalian cells requires monitoring of HCPs as impurities. Immunoassays are still the method of choice for release testing, for which it is recommended to demonstrate the suitability of antisera in a QM-regulated environment to meet regulatory demands. Demonstrating antisera coverage to and characterization of HCPs as antigens is one most critical point. We present approaches for qualitative detection of HCPs, antisera characterization and comparison of HCP batches using 2D-DIGE, 2D gels and blots. These methods need to be applied…

Advanced Services for Host Cell Protein Analysis Brochure

Advanced Services for Host Cell Protein Analysis Advanced Services for Host Cell Protein Analysis Mass spectrometry services for analysis of HCPs A critical task in biologics manufacturing is the control of processrelated impurities particularly host cell proteins (HCPs), which co-purify with the drug substance and are known for adverse effects (e.g. immunogenicity) during patient treatment. For decades, the method of choice to detect host cell proteins has been an immunoassay based on polyclonal antisera raised against a population of HCPs. However, there are some inevitable risk factors…

Differential Protein Display Brochure

Differential Protein Display Differential Protein Display Getting competitive advantage for your products by modern protein analysis Proteins are important for every aspect of our life Proteins fulfill all functions in life. Our skin and our hair are made of proteins. Our muscle proteins allow us to move and our brain proteins build the most sophisticated computer known to man. Special proteins, like enzymes are digesting our foods and receptors proteins connect us to the environment. Proteins are important in each and every organism and they are also relevant in our daily life from…

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Protagen Protein Services (PPS) is a world leading CRO and recognized expert for analytical services in protein science regarding characterization, method development, validation and routine testing of antibodies, proteins, vaccines and other formates of biopharmaceuticals. Our sites are equipped with modern, state-of-the-art equipment for the analytical characterization of biopharmaceuticals regarding structure, purity, chemical modification, aggregation, particle formation, thermal stability e.g.. We offer service modules for analytcal support from research to approval regarding:

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