Katharina Künzel, Boehringer Ingelheim Pharma, Analytical Dev. Biologicals, Biberach, Germany

Potency assays such as cell-based bioassays as well as ELISA binding assays are employed for release and stability testing of biologics and to study their structure function relationships. For each NBE, individual potency assays reflecting the mode of action need to be developed for routine analytics. The current procedures for potency assays require a number of complex and labor-intensive steps, which limit sample throughput and introduce sources of variability.

Rachida Siham Bel Aiba, Pieris Pharmaceuticals GmbH, Freising, Germany

Pieris Pharmaceuticals utilizes a unique drug scaffold platform known as Anticalin proteins to develop differentiated medicines in the areas of Immuno Oncology and Respiratory Disease. Anticalin proteins are based on lipocalins, a family of endogenous low-molecular weight human proteins typically found in blood plasma and other body fluids. Randomization of lipocalin loop regions results in Anticalin proteins that can recognize and specifically bind to a wide range of medically relevant targets.

Stefan Ewert, Associate Director, Novartis Pharma AG, Basel, Switzerland

We will show adaptations to library design and planning strategies exploiting the full potential of deep sequencing analysis of phage selection output pools to identify specific and high affine antibodies without conventional screening.

Ulrike Herbrand, Charles River Biologics Testing Solutions, Max-Planck-Str. 15A, 40699 Erkrath, Germany

Bioactivity assays are a central and critical requirement for all biopharmaceutical products throughout product development and manufacturing and they should reflect the mechanism of action (MoA). The bioactivity of a test item is estimated by measurement of the biological response that it produces compared to the reference item and data are analyzed using methods of biostatistics.

Ernst Weber, Bayer AG, Leverkusen

Multiple parameters of an antibody have to be met in order to qualify an initial screening hit as suitable candidate for development and to finally become a drug. They include i) functional parameters like high affinity, potency and x-reactivity vs. different species, ii) CMC related aspects like solubility, viscosity, temperature stability and iii) sequence related features like potential CMC relevant amino acid residues and T-cell epitopes.