Bioprocessing Application Notes & Case Studies

  1. Unlock Oral Delivery Potential For Macromolecules With A Parallel Screening Approach

    Identifying the optimal formulation and dose form which shows an increase more than 20 times in the oral bioavailability of Salmon Calcitonin.

  2. Developing Oral Dosage Forms: An Approach For Faster Path To Market

    How an agnostic and data-driven approach early on can optimize the development pathway to bring the molecule to the market faster.

  3. New Performance Assay For Eshmuno® P Resins

    To reduce the variability in the measurement of the anti-A and anti-B titers, an assay was developed for the routine quality control testing of Eshmuno® P resins.

  4. Chromatography Resins For The Removal Of Unwanted Anti-A And Anti-B Antibodies

    Resins allow customers to design the immunoglobulin purification processes with a primary goal of reducing patient risk through an additional chromatography operation.

  5. Medium Preparation For Single-Use Fermentation

    Single‑use fermenters are becoming an increasingly viable alternative to stainless steel, offering less time is spent on equipment preparation and qualification prior to start-up as well as routine maintenance and requalification of the equipment.

  6. Single-Use Stirred Tank Fermentor System Performance Comparison

    The process design proven for one fermentor system is not always directly transferrable to other system formats without adaptation. Here, we compare the performance of the XDR‑500 MO fermentor with the XDR‑50 MO system.

  7. Roivant Sciences Accelerates Process Development To Speed Orphan Therapy To Market

    This case study shares the work of GE’s Fast Trak Services team to help accelerate development of a process for cGMP production of material for toxicology studies.

  8. Production Of Recombinant Proteins Using A Scalable Metal Affinity Resin

    A three-column workflow has been developed for the purification of a histidine-tagged recombinant protein from E. coli extract. The macroporous Ni2+-charged Nuvia IMAC Resin provides efficient capture of the target protein molecules with excellent selectivity, binding capacity, and recovery. The subsequent mixed-mode chromatography steps, performed with Nuvia™ cPrime™ Resin followed by CHT™ Ceramic Hydroxyapatite Media, eliminate leached Ni2+ ions and offer further clearance of residual impurities from host cells.

  9. Single-Use Workflow For Recovery Of A Domain Antibody From E. Coli Culture Feed In An Automated Manner

    This application note demonstrates the performance of the automated ÄKTA™ readyflux single-use filtration system in microfiltration applications. 

  10. Automated Ultrafiltration/Diafiltration Results With Minimized Hands-on Time

    This work describes the capabilities of ÄKTA readyflux when used in ultrafiltration/diafiltration (UF/DF) applications. The process was conducted in an automated manner based on methods created using phases predefined in the UNICORN™ system control software.