Octapharma社、Genedata Bioprocessを導入：次世代バイオプロセス研究開発を支援

血漿分画製剤メーカーOctapharma社、細胞株構築・培養・精製・製剤、GMPに基づく品質管理、治験薬の在庫管理にGenedata Bioprocessを活用

October 29, 2019
Basel, Switzerland

Genedata, the leading provider of enterprise software solutions for biopharmaceutical R&D, today announced that Octapharma, one of the world’s largest human protein manufacturers, has adopted the Genedata Bioprocess^® platform to support the development and manufacturing of therapeutic proteins addressing severe diseases in the areas of haematology, immunotherapy, and critical care.

“By bringing Genedata Bioprocess onboard, we will be able to digitalize our development and manufacturing processes and get to the next level of operational excellence. Streamlining processes while maintaining highest quality standards was the guiding principle behind our selection of Genedata,” said Dr. Tobias Stuwe, Head of Recombinant R&D at Octapharma. “As a fully integrated end-to-end platform, Genedata Bioprocess integrates data capture, analysis, and reporting across all of our bioprocess development operations, which will increase overall productivity. In addition to these operational benefits, Genedata Bioprocess serves as our central data backbone to ensure data integrity and compliance.”

The system is being rolled out across the Octapharma organization, including groups for clinical supply and formulation development, purification and analytics, biophysics, fermentation, cell line development, molecular design, as well as Octapharma’s production and QC units in a GMP environment. All groups will have a central place to record and access business-critical information in real time, which will foster collaboration and ultimately help to make Octapharma’s development and manufacturing operations even more efficient.

E2E Platform for Bioprocess Development & CMC
Genedata Bioprocess is the leading biopharma R&D workflow platform, integrating processes and connecting people, data, and laboratory instruments to make corporate-wide development and manufacturing operations more efficient. The platform scales with highest data volumes and integrates all critical data, such as from bioreactors, downstream unit operations, or analytics devices. By harmonizing workflows, streamlining communications, giving real-time access to all project information, and enabling full automation and high-throughput processes, the platform reduces costs and dramatically improves overall productivity. Genedata Bioprocess supports the entire end-to-end (E2E) process, covering cell line development (CLD), upstream process development (USP), downstream process development (DSP), formulation development (FD), process analytical support, and analytical development (AD).

“We are pleased that Octapharma, a leader in therapeutic protein manufacturing, has decided to implement Genedata Bioprocess to handle the many challenges in large-molecule development and manufacturing,” said Dr. Othmar Pfannes, CEO of Genedata.  “We are excited to combine Genedata’s advanced software solutions and expertise with Octapharma’s market-leading human protein development and production, which will further support our mutual goals of advancing human life."

About Octapharma
Family-owned since being established in 1983, Octapharma is a global healthcare company headquartered in Lachen, Switzerland. Our products are available in 115 countries and reach hundreds of thousands of patients every year focussing on three therapeutic areas: haematology, immunotherapy and critical care.

Octapharma is one of the largest human protein product manufacturers. We develop and produce medicines based on human proteins from human cell lines and human plasma, sourced from our own plasma donation centres and other external sources.