Genedata Bioprocess

Key Features

Genedata Bioprocess® is an enterprise workflow system that enables a significant increase in throughput and efficiency for bioprocess research and development units. The platform's extensive built-in business logic supports the entire workflow, from early cell line screening to downstream process and analytical development. The system can be used to develop manufacturing processes for both antibodies (IgGs, novel formats, such as bi- and multi-specifics, ADCs) and therapeutic proteins (e.g., engineered FVIII variants, fusion proteins). Genedata Bioprocess works out-of-the-box and has been specifically designed to simplify and accelerate biologics development.

Developability and Manufacturability Assessment
Comprehensive and systematic assessment of quality, developability and manufacturability

The Quality by Design (QbD) approach is applied in the development of drug candidate manufacturing processes. Using this approach, the Quality Target Product Profile (QTPP) is compiled, which encompasses the drug product characteristics needed to ensure the drug’s quality, efficacy, and safety in patients. This profile summarizes the design criteria for the drug product and can be linked to the product’s critical quality attributes (CQAs).

The identification of the critical attributes from all potential product quality attributes begins in drug discovery and continues in early drug development, where the effects of the production process on the molecule quality is studied in more depth. As a result, all knowledge about a molecule’s properties and characteristics and its manufacturability and developability must be taken into account as early as possible. The goal is to develop the most efficient manufacturing process - one which has a low risk of failure and a high probability of stably delivering a superior quality drug product.

Genedata Bioprocess captures and structures all product quality attributes and process attributes acquired along the biologics late-stage research and early-stage development workflows. The data is associated to molecules, cell lines, and samples, along with corresponding key process parameters describing the generation of the corresponding sample. The platform provides views and reports, as well as data visualization tools, to guide the choice of the best drug candidate. This supports the selection of candidates by development and research organizations and the selection of best processes by groups who jointly work on process development within a development organization. Developability assessment views feature intuitive color-coding, showing the outcome of analytical tests, and indicating whether or not the results meet the preset developability criteria.

Development Based on Structured High-Quality Data
Holistic development of manufacturing processes, reflecting biologics production workflows

Today’s R&D organizations are highly connected and interdependent. Each group involved in process development needs to take product quality criteria and the corresponding data into account when selecting the best-producer cell line or when designing the best upstream, downstream, or formulation process. It is vital that scientists and engineers learn how each process step influences product quality - how the selection of the cell line and certain process parameters in upstream or downstream processes influences critical product quality attributes. This is facilitated by close collaboration between cell line development, upstream, downstream and process analytical groups.

Genedata Bioprocess enables a holistic development of manufacturing processes. Each group can contribute experimental results to the system along their individual workflows. The system’s built-in business logic tracks the lineage of molecules, cell lines, batches, vials and plates and associates analytical results in a standardized way. In the case of cell line development, for example, Genedata Bioprocess tracks and documents the full history of each cell line and collects all relevant characterization data, such as productivity and quality parameters, in order to streamline the underlying laboratory workflows.

The system provides central access to all upstream and downstream data to every scientist and engineer involved in a project. Rights to modify data are selectively assigned via well-defined user roles and individual data modifications are tracked. The underlying business logic includes consistency checks to prevent unwanted creation or deletion of data. Genedata Bioprocess provides a structured repository of process and product quality information. It performs lineage tracking of molecules, cell lines and samples, which improves the quality of submitted data and enables careful data curation. These data structuring and curation capabilities represent a foundation for the holistic assessment of process development.

Coping with the Large-Molecule Diversity in Process Development
Handle diversity of modalities and molecule types among large-molecule drug candidates

The increasing diversity of modalities and molecule types among large-molecule drug candidates makes it difficult to use rigid, non-adaptable process development platforms. Development organizations deal with heterogeneous molecule types ranging from classical monospecific IgG1 antibody molecules - via various isotypes of antibodies, bi- and multispecific antibody formats, fusion proteins and replacement therapeutics - to various vaccine types and even cell therapeutics. Process development groups need to therefore adapt their process platforms to individual molecule types using tailored process parameter screening approaches.

Genedata Bioprocess enables the registration of the primary structure of all the different types of biologics molecules with their different number of chains and target-specificities. Automatic annotation routines assign Complementarity Determining Regions (CDRs) and Framework Regions (FRs) of variable antibody domains as well as other functional domains and specific amino acid exchanges derived from engineering approaches. This includes potential liability sites, such as oxidation and deamidation sites. The system can flexibly track and register molecule modifications, such as toxophore conjugation for Antibody Drug Candidates (ADCs) or proteolytic cleavages and post-production complexation (antibody chain exchange for bi-/multispecifics generation). It automatically calculates the molecules’ physicochemical properties and stores and automatically annotates corresponding expression construct maps. The system serves as a single point of reference for molecule information for the whole development organization.

Genedata Bioprocess provides a unified platform for viewing data across different molecules, cell lines, and process development campaigns. It provides the basis for sharing insights within and across projects, for knowledge sharing within development groups, between discovery and development organizations, and even between development and manufacturing organizations.

Miniaturized Screening and Automation in Cell Line and Process Development
Increasing throughput using scale-down models for bioreactors, filters, and chromatography

New methods in molecular and cell biology, in analytics (including Process Analytical Techniques (PATs)), in process miniaturization, and in automation promise to make process development more efficient. This technological progress provides new ways to shorten timelines for large-molecule manufacturing process development and to reach proof-of-concept decision points earlier in clinical studies, ultimately reducing time to market.

Genedata Bioprocess is especially designed to meet the challenges associated with these new methods and technologies. It supports miniaturized screening approaches in scale-down models, such as micro-bioreactors or other unit operations. With a scalable architecture, it can capture the increasing amount of analytical data coming from different measurement devices, bioreactors, and other unit operations. The system can be directly integrated with laboratory equipment, including liquid handling systems, screening robots, bioreactors, and analytical devices. Information originating from different sources and systems is automatically processed, analyzed, and shared between different teams, including cell line development, upstream, downstream, formulation, and analytical development groups.

Sample & Inventory Management
Fully integrated sample registration and tracking system

Genedata Bioprocess is built upon a full-fledged sample and inventory management system. All samples, such as cell lines and upstream and downstream batches, are registered and assigned unique IDs before undergoing subsequent testing. In addition, all raw materials and compositions thereof, such as buffers and media, are registered together with QC information and connected with sample and process steps. All aliquots are centrally registered, including the physical location and the distribution status of each sample. The system supports both low-throughput manual, as well as high-throughput fully automated and barcoded sample management processes. Comprehensive Certificate-of-Analysis (CoA) documents and other reports are auto-generated and can be produced at any point in the workflow.

Request Management
Streamlining operations along the entire development lifecycle

The Request Management Module efficiently manages each step in the bioprocess development workflow and simultaneously monitors all operations. The system tracks the full lifecycle of task scheduling and enables real-time monitoring of the progression of requests. This is particularly valuable in a division-of-labor organization in which completion of experiments requires close interaction between expression, purification, analytics, assay and other teams, and integration of tasks performed by CROs and other external collaborators is also necessary. The system standardizes and streamlines intergroup communication by giving users a platform to prioritize, schedule, and fulfill complex iterative, multi-step requests, to communicate status updates for each task, and to ensure all steps are completed on time. Automated email notifications provide timely updates on request status to all relevant stakeholders as the request progresses through the organization based on configurable and pre-defined cascades depending on e.g., the protein and cell line type. Dedicated dashboards give requesters a comprehensive overview of requests, status, and progress. The Request Management Module can be fully integrated with Genedata Bioprocess and directly linked to all related entities for quick access to all relevant information about the request.