Symphogen to present second-generation Sympress platform at ESACT conference

Symphogen, a private biopharmaceutical company developing superior antibody therapeutics to treat cancer, infectious and autoimmune diseases, announced today that second-generation enhancements to the company's SYMPRESS™ manufacturing and quality control platform will be presented in an oral presentation entitled "Recombinant antibody mixtures; optimization of cell line generation and single-batch manufacturing processes" by Dr. Søren K. Rasmussen, Principal Scientist, Symphogen at the upcoming European Society for Animal Cell Technology (ESACT) conference in Vienna on May 17, 2011. Additionally, a paper published online April 25, 2011 in BIOTECHNOLOGY and BIOENGINEERING describes Symphogen's proprietary Sympress™ manufacturing, release and characterization strategy for rozrolimupab/Sym001, a recombinant polyclonal antibody product in Phase 2 clinical trials.

Presentation at ESACT Conference

At the 2011 ESACT conference taking place at the Vienna Hofburg Congress Centre, Austria, Dr. Rasmussen will on May 17 at 9.35 am give an oral presentation entitled "Recombinant antibody mixtures; optimization of cell line generation and single-batch manufacturing processes". Dr. Rasmussen will present data on Symphogen´s high-titered second-generation Sympress™ platform in which production levels have been increased to g/L titers while maintaining the robustness and consistency of the original Sympress™ platform. The optimized manufacturing platform is built on a new proprietary host cell line, a CHO DG44 derivative, and integrates automated cell line development processes and robotic handling of cell cultures to increase throughput and process documentation.

BIOTECHNOLOGY AND BIOENGINEERING Paper

The Biotechnology and Bioengineering paper, entitled "Consistent manufacturing and quality control of a highly complex recombinant polyclonal antibody product for human therapeutic use", describes a cost-effective cell banking and single-batch manufacturing concept for the production of rozrolimupab/Sym001 and demonstrates that this complex composition comprising 25 individual antibodies can be manufactured in a highly consistent manner in a scaled-up manufacturing process. Selected quality attributes of rozrolimupab are documented based on a battery of release assays including a number of product specific assays at the genetic, protein, and functional level, demonstrating that the manufactured product batches are highly pure and very uniform in their composition. Prior to the work done at Symphogen and described in this article, the achievement of robust and consistent single-batch manufacturing of batches containing several constituent antibodies at large scale had not been achieved. The paper was authored by scientists at Symphogen and SOBI (Swedish Orphan Biovitrum), Sweden, as well as NIBSC, Health Protection Agency, UK. Its authors are Torben P. Frandsen, Henrik Næsted, Søren K. Rasmussen, Peter Hauptig, Finn C. Wiberg, Lone Kjær Rasmussen, Anne Marie Valentin Jensen, Pia Persson, Margareta Wikén, Anders Engström, Yun Jiang, Susan J. Thorpe, Cecilia Förberg, and Anne B. Tolstrup.

According to Chief Executive Officer Kirsten Drejer, Ph.D. "The strategy described represents a relatively simple approach to the production of complex mixtures of antibodies that also integrates flexibility relative to the number of antibodies and the design of the composition. As such, from a practical point of view as well as the point of view of developmental cost efficiency, our team's work provides a foundation for moving ahead on several different fronts. Importantly, the regulatory release and characterization strategy described in the Biotechnology and Bioengineering paper is built on existing guidance for mAbs as well as on constructive interactions with regulatory agencies, notably the US FDA, as it includes product specific assays that address the polycolonality of the products at multiple levels, ensuring the release of antibody mixtures as well characterized biologics."