Outsourced Pharma App Notes & Case Studies

  1. Microbial Fermentation In Single-Use Xcellerex™ XDR-50 MO Fermentor System

    This application note describes the performance of a single-use Xcellerex XDR-50 bioreactor system when used in cultivations of E. coli and of modified Pseudomonas fluorecsens (P. fluorescens) producing a monoclonal antibody (MAb). Both the achieved microbe densities and product yield were shown to be consistent with the performance of conventional stainless steel systems.

  2. Developing Cleaning-In-Place Protocols For Chromatography Media

    Cleaning-in-place (CIP) of chromatography media (resins) is important for the integrity and safety of the final biopharmaceutical product. Efficient and media compatible cleaning procedures also increase the column lifetime and thereby contribute to cost effective processes.

  3. Optimizing Elution Conditions On Capto MMC Using Design Of Experiments

    The multimodal ligand of Capto™ MMC generally requires elution conditions that diff er from those used with traditional ion exchangers. This application note describes how Design of Experiments (DoE) can be used to optimize elution conditions and thus recovery of a target protein

  4. Automated pH Adjustment In An Intelligent Single-Use Mixing Platform

    Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.

  5. Improve Throughput And Cost With Continuous Downstream mAb Processing

    In this study, periodic counter current chromatography and straight-through processing technologies were evaluated in a continuous three-step monoclonal antibody purification process.

  6. An Environmental Life Cycle Comparison Of Single-Use And Conventional Bioprocessing Technology

    Biopharmaceutical development and manufacturing demand scalable processes that can be smoothly transferred to production. These processes need to be quickly developed and easy to implement.

  7. A Cost-Effective Alternative To Size Exclusion Chromatography

    The aim with this white paper is to discuss the advantages of using Capto Core 700 in virus purification compared to size exclusion chromatography (SEC), a technique commonly used in several vaccine processes.

  8. Purification Of An N-Terminal Histidine-Tagged Protein Using ÄKTA™ start

    ÄKTA start eliminates the hassles of manual protein purification handling, such as loading large sample volumes and continually monitoring UV readings, and can give you consistency of yield and purity. Madhu demonstrates how ÄKTA start aided him in purifying a recombinant N-terminal histidine-tagged protein.

  9. Collaborative Project To Accelerate Downstream Biosimilar Processes

    This case study demonstrates the optimization of the downstream purification process to improve product purity and recovery of the biosimilar Fc-fusion protein.

  10. GE Works On Single-Use Film To Achieve Optimal Performance In Biomanufacturing

    The PDA Journal of Pharmaceutical Science and Technology, have taught us that using materials not intended for use with pharmaceuticals was not the best choice. The industry is now evolving toward developing single-use films better suited to fit the needs of biomanufacturing, specifically, end users that have communicated a need for improved film performance with reliable supply, which requires transparency along the entire supply chain.