Bioprocessing Application Notes & Case Studies

  1. Intensified Seed Train Strategy For Faster, Cost-Effective Scale-Up Of Biologics Manufacturing 5/12/2021

    The biopharmaceutical industry is looking at process intensification as a means to cost-effectively produce monoclonal antibodies (mAbs). This article explores intensified processing of Chinese hamster ovary clones in the seed train of upstream cell cultures to support generation of high-cell-density cell banks and increased production of mAbs.

  2. Real World Experience: Modular Facilities, Smaller Footprint With Dynamic Perfusion 5/11/2021

    Established manufacturers are looking to single-use, flexible solutions when building new facilities or modifying existing operations. Their goal is to increase productivity across different modalities, including difficult-to-express molecules. Read this success story to understand how dynamic perfusion enabled a CDMO to increase throughput dramatically while establishing a multi-modality facility.

  3. Cell Culture Media Performance Using Viresolve® Barrier Filters 5/10/2021

    Bioreactors are at particular risk of contamination from adventitious agents introduced into the process from multiple sources including raw materials, equipment, and personnel. To ensure sterility, cell culture media and feeds are typically sterile filtered at the time of bioreactor fill. However, virus contamination incidents have led biotherapeutic manufacturers to consider an additional level of protection for their cell culture processes. This study evaluates the performance of Viresolve® Barrier filters, designed to remove viruses from chemically defined cell culture media in a typical CHO fed-batch process.

  4. Viresolve® Barrier Filters Performance Guide 5/10/2021

    Viresolve® Barrier filters are designed to remove viruses from cell culture media to reduce the risk of bioreactor contamination. This guide is a reference that provides summary information to assist in the evaluation of Viresolve® Barrier filters, as well as an overview of Viresolve® Barrier filter performance.

  5. How To Optimize A Clinical Scale Manufacturing Process For Commercial Production 5/10/2021

    Given the large, global population of people affected by rheumatoid arthritis and the original mechanism of action of olokizumab, R-Pharm expects significant demand for the drug. The initial process used to manufacture drug substance for clinical trials was established nearly eight years ago. In this case study, you will discover more about how the R-Pharm Group collaborated with MilliporeSigma’s BioReliance® End-to-End Solutions to manufacture olokizumab for commercial production.

  6. Cellvento® 4CHO Fed-batch Medium 4/26/2021

    Different CHO hosts are used routinely to develop such biologics and are combined with several expression system like the dhfr, the UCOE or the glutamine synthetase (GS) system. The platform described in this process guidance was developed to grow a broad range of CHO cells. The production medium supports initial cell growth and production while the highly concentrated, neutral pH feed is added to replenish depleted nutrients required for cellular function and to maintain and extend the production phase in fed-batch mode.

  7. 1X PBS (Phosphate Buffered Saline) Buffer Mixing Optimization 4/23/2021

    This study develops optimal process conditions for mixing and filtering of 1X PBS buffer using the 50 L, 200 L, and 1000 L Mobius® Single-Use Mixing Solution, Durapore® and Millipore Express® filters.

  8. Dilution Of Multiple Buffer Concentrates With One Single-Use Flow Path 4/21/2021

    The Allegro™ connect buffer management system is suitable for application with capture, purification and polishing chromatographic operations. Furthermore, the system can provide a continuous supply of multiple in-specification diluted buffers with minimal downtime and is suitable to support continuous operations such as multi-column chromatography and multi-buffer filtration operations.

  9. Spray-Dried Dispersions Enable Local Delivery For Lung Cancer 4/20/2021

    Spray drying is a leading technology for particle engineering and particularly advantageous for manufacturing particles in the inhalable range of 1-5 microns. Learn more about spray drying through two case studies of inhaled dry powders.

  10. Advanced Formulation Development By Design In The Context Of Holistic Drug Production 4/15/2021

    A trend in drug substance and drug product biomanufacturing is increasing therapeutic complexity. Solving complex challenges calls for innovative mindsets, technological advancement, and proficient and complementary expertise.