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),…

GMP compliant Protein Analysis and Characterization Product Information: GMP compliant Protein Analysis and Characterization GMP-compliant Protein Analysis Founded in 1997, Protagen Protein Services GmbH (PPS) has established and successfully expanded a fee-for-service business in protein and peptide analysis. The service platform now comprises method development, qualification and validation, comparability of biologics, complete protein characterization and release testing and GMP-compliant protein analysis for quality control of biotherapeutics. The strong commitment to quality is…

The development and production of recombinant biopharmaceuticals is a challenging field
due to their structural complexity. When implementing a manufacturing process for new
biological entities (NBEs) or biosimilars, variations in the protein structure or posttranslational
modifications can occur. Therefore a characterization program is required following the biopharmaceutical guidelines (ICH Q6B).

The development and production of recombinant biosimilars is a challenging field due to their structural complexity. When implementing a manufacturing process for biosimilars, differences in the protein structure or post-translational modifications can occur. Therefore a characterization program is required following the biosimilar guidelines. Of great interest are protein glycosylations which can have a great influence on efficacy and safety of the biopharmaceutical. Glycosylations are usually analyzed after isolation from the protein by HPAEC-PAD or HILIC-FLD. Alternatively, LC-ESI-MS…

Bei der Entwicklung eines Biosimilars ist die Ähnlichkeitsanalyse zum Originator für den Erfolg entscheidend. Die Anwendung von Hochleistungsanalytik wie zum Beispiel der Protein-Massenspektrometrie liefert auch für strukturell sehr komplexe Biotherapeutika umfangreiche Daten zu mehreren Hundert Qualitätsattributen und damit die Basis der Vergleichbarkeit.

The stratum corneum, representing the outmost layer of the skin, is a vitally important barrier of the body and protects it from various environmental stress factors. In order to maintain its elasticity, suppleness and barrier function, the skin requires optimal water content. In order to guarantee these functions skin moisture is tightly regulated by two factors, namely by the integrity of the water impermeable barrier of the skin itself and by the content of water-binding substances in the stratum corneum.

In recent years the development of biopharmaceuticals hasincreased enormously and also in the next years an immensegrowth is expected. The production of recombinant antibodies is a challenging field of great commercial value. Changes in the proteinstructure or posttranslational modifications can occur and these canhave negative effects on the function of the protein and on thetherapeutic efficacy. Currently very important modifications oftherapeutic antibodies are glycosylation, deamidation or C-terminalLysine cleavage. We have developed methods for the preciseanalysis of these modifications.…