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…

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.

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…

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…

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…

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…

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 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 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…

GMP compliant Characterization of Therapeutic Antibodies according ICHQ6B GMP compliant Characterization of Therapeutic Antibodies according to ICH Guidelines Q6B Characterization of Therapeutic Antibodies 6B H Q FD IC A EMA MP G The complex nature of antibodies as therapeutics presents numerous challenges during development and manufacture. These protein therapeutics are often heterogeneous and therefore complex to characterize. Overall small changes in the protein structure, such as glycosylation, disulfide linkage or presence of some low level impurities (e.g. deamidation/oxidation),…