Protein biopharmaceuticals are macromolecules with a therapeutic effect, commonly
produced by the recombinant DNA technology. They have emerged as important …

Protein biopharmaceuticals such as monoclonal antibodies and therapeutic proteins are
currently in widespread use for the treatment of various life-threatening diseases including …

Remsima®(infliximab) was recently approved as the world's first biosimilar monoclonal
antibody (mAb) in both the European Union and Korea. To achieve this, extensive …

Highlights•The current status of continuous cell culture and downstream processes is
presented.•The impact of continuous operation on product quality is shown.•Resulting …

Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry.
Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with …

In a defining moment for the European Medicines Agency (EMA) and the biopharmaceutical
industry, on June 27, 2013 EMA's Committee for Medicinal Products for Human Use adopted …

Background ABP 501 is being developed as a biosimilar to adalimumab. Comprehensive
comparative analytical characterization studies have been conducted and completed …

The extensive analytical characterization of protein biotherapeutics, especially of
biosimilars, is a critical part of the product development and registration. High-resolution …

In the last decade, the advancement of liquid chromatography mass spectrometry (LC/MS)
techniques has enabled their broad application in protein characterization, both …

Recombinant DNA technology and corresponding innovations in molecular biology,
chemistry and medicine have led to novel therapeutic biomacromolecules as lead …