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.…

Signal transduction is an important biological process conducted by a
variety of protein protein interactions (PPIs) which transduce external
signals into cellular responses. Proteome analysis has the potential to
uncover these mechanisms but has limitations. Membrane receptors,
kinases and transcription factors are normally underrepresented in a typical proteome study but are most interesting targets for drug development. To get access to these protein classes high-confidence PPI datasets can be used to predict potentially involved proteins on the basis of…

The success of protein based therapeutics, e.g. monoclonal antibodies, interferons, hormones etc., in the last years generated one of the fastest growing segments in the pharmaceutical industry. Furthermore, whilst some of these blockbusters drugs are already out of patent protection, an increasing number of companies enter into the field of bio-generics production. Since the withdrawal of Tysabri (Biogen Idec) from the market in 2005 and the severe side effects of Supermab recognized in a clinical phase I study in 2006, bio-therapeutics and their precise analysis on the molecular level came…

Die Automatisierung von Proteomanalysen ist von großem Interesse, allerdings hat die Vielfaltder Analysetechniken sowie die Komplexität der Analyseschritte eine allgemein verwendbareAutomatisierung bislang erschwert. Für Proteomstudien mit Hilfe von 2D-Gelen und massen-spektrometrischer Analyse gibt es inzwischen einen weitgehend standardisierten, automati-sierbaren Arbeitsablauf. Mehrere Firmenbieten komplette Geräte-Lösungen (Proteomics-Stra-ßen) oder Teillösungen an. Die elektronische Datenverarbeitung soll dabei die Aufgaben eines‚Labor Informations Management Systems‘ (LIMS) …