Genedata Bioprocess

Downstream Processing

The recovery and purification of large molecules is an essential process in the manufacture of biopharmaceuticals. Downstream Processing (DSP) is a complex, iterative, multi-step process and includes a combination of various unit operations, such as centrifugation, filtration, chromatography, and viral inactivation. The application of more and more scale-down models for different unit operations and the introduction of new process analytical technologies has produced huge amounts of data that need to be captured, processed, and analyzed in the context of applied DSP process parameters.

Genedata Bioprocess® makes the development of new or optimized downstream processes more efficient by providing a fully integrated infrastructure that tracks all unit operations with specific process parameters, all combinations of unit operations, in-process samples, and process and product analytical data.

Integrate

Integrates the full DSP process including all unit operations with upstream process data, such as cell line, expression construct, and molecule information, as well as product analytical data; makes downstream process assessment more comprehensive and systematic; integrates information from scale-down systems to full manufacturing scale

Capture

Captures all data from unit operations, such as filtration and chromatography operations, including instrument equipment information (e.g., columns, filters), process parameters (e.g., flow rate, pressure), raw materials (e.g., resins, buffers), and process input and output details (e.g., loaded amount, recovery, step yield, overall yield) including analytical data from unit operation control software, such as Unicorn, Chromeleon, or Empower (e.g., chromatogram images and related peak calculation data); captures product analytics data, such as residual analysis (e.g., host cell protein, HCP), analytical size exclusion chromatography, and isoelectric focusing results

Process

Processes captured data including auto-calculations (e.g., step recovery) and tracks lineage of all batches and samples resulting from different unit operations including in-process samples and fractions, pooled or split materials  

Interpret

Interprets and analyzes all factors required to guide downstream process development including screening of optimized resins, membranes, buffers and other parameters, as well as characterizes and validates processes via built-in multi-parameter visualization and evaluation tools

Report

Reports the full purification history of all batches together with their unit operations genealogy; automatically generates certificates of analyses for each batch in one click; facilitates the hand over between DSP teams and respective upstream processing, formulation, and analytical teams

Enable

Enables high-throughput DSP processes (e.g., using microtiter-plate compatible chromatography columns or ambr crossflow) to identify the optimal combination of process parameters