New Workflow Platform for Biopharmaceutical Development
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Genedata has announced the release of Genedata Bioprocess™ off-the-shelf enterprise software solution that makes large-molecule development and CMC activities more efficient and improves process quality. Genedata Bioprocess streamlines and automates complex workflows in cell line development, upstream and downstream process development (USP and DSP) workflows, drug formulation, and analytical development.
By supporting the complete large-molecule development workflow, it enables biopharmaceutical, biotechnology, as well as contract manufacturing organizations to more efficiently develop and manufacture novel and generic protein-based therapeutics. Genedata Bioprocess is the result of long-term collaborations with several biopharmaceutical and biotech partners. The platform will be featured for the first time at the Cell Line Development & Engineering Conference 2016 (Vienna, Austria, April 11-13).
"We are very excited about the first release of Genedata Bioprocess, which automates complex processes in large-molecule development and generates significant efficiencies for our customers," noted Dr. Othmar Pfannes, CEO of Genedata. "With Genedata Bioprocess, we expand our portfolio of innovative software solutions for biopharma R&D and the biosimilars market. We see a rapidly growing need for fully integrated enterprise platforms that enable our customers to discover, develop, and manufacture biopharmaceuticals in an industrialized and most cost-efficient manner. Genedata is committed to continue investing in innovative software solutions to address these needs."
Industry's First Fully Integrated System for Biopharma Process Development Genedata Bioprocess is the first, fully integrated workflow management platform for biopharma process development that enables automated, high-throughput workflows, and streamlines work in a division-of-labor environment. Its built-in reporting capabilities manage and document all relevant large-molecule CMC activities for any given candidate and handle candidate handover from discovery all the way down to the filing of Biologics License Applications (BLA).
The platform can be applied to both antibodies (IgGs, bispecifics, ADCs), antibody mimetics (non-Ig scaffolds), and therapeutic proteins (e.g., engineered FVIII variants, fusion proteins). Genedata Bioprocess is built on a comprehensive process database with a sophisticated data capture and processing infrastructure. The highly structured database, which incorporates biological domain knowledge, allows for advanced process analytics.
Genedata Bioprocess version 1.0 consists of three application modules, which can be installed and operated individually or in a fully integrated setup:
Clone Selection Module for cell line development. This includes registration of all cell lines (primary host cell lines and developed cell lines) and tracking of complete cell line genealogy. The platform records all steps and conditions in the clone selection process (e.g., transfection, seeding, incubation, selection, passaging, freeze-thaw cycles, subcloning) and all process decisions and clone selection criteria (e.g., confluence, monoclonality, titers, genetic stability).
Fully compatible with high-throughput clone screening instruments, it provides full plate logistics tools to manage and track cell lines in microtiter plates and other containers, such as deep-well plates, cultiflasks, and bioreactors.
Product & Quality Module for expression, purification, formulation, and analytical development. This provides a full-fledged molecule and sample management system that assigns unique IDs to each molecule and its corresponding samples, such as expression or purification batches, for authoritative sample identification during testing and storage.
In addition, integrated management of molecule primary structures (AA sequences) and analytics data (mass spectrometry/MS, SEC, HIC, SPR, CEX, BLI) enables in-depth assessment of the product's developability, manufacturability, and critical quality attributes (CQA), such as aggregation or stability. Comprehensive Certificate-of-Analysis (CoA) documents and other reports are auto-generated. The fully integrated sample and analytics infrastructure makes downstream process development significantly more efficient.
Bioreactor Module for upstream process development. This module enables a systematic and integrated analysis of all bioreactor online and offline data. It includes tools for the identification of critical process parameters and their impact on clone productivity and product quality (e.g., dependency of N-glycan patterns on feeding strategy and lactate-VCD correlations). Typical applications are to optimize media and feeding strategies and extrapolate to larger bioreactor scales to guide upscaling campaigns.
The platform supports the incremental upscaling of bioreactor volumes to full manufacturing scale. Dedicated functionalities are included to systematically analyze highly parallelized fermentations (e.g., data from scale-down bioreactors, such as ambr®).
Genedata Bioprocess is based on an open system architecture, which allows for simple yet flexible integration with various laboratory instruments, including bioreactors, analytical devices, or liquid handling systems, to address customer-specific integration requirements. Its modular architecture meets user-specific requirements, enabling use of the solution throughout the entire development workflow.
