Biosimilar Development insights

  1. 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.

  2. 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.

  3. Is Selecting A CDMO Based On Contract Price Really Saving You Money In The Long Run?

    Considerations when choosing a contract manufacturer for drug substance development or finished dosage forms.

  4. Evaluation For Ultrafiltration To High Protein Concentration Using TFF

    This study, performed with a prototype system, is designed to confirm the system’s suitability for concentration and diafiltration steps to high final concentrations up to 150 g/L.

  5. Is Your API Ready For Scale-Up? What To Demand From Your CDMO.

    A CDMO that can optimize your API synthesis process early during technology transfer will reduce the risk of project delay or failure. That will also help your molecule run more efficiently in their plant. And time is money.

  6. How To Use QbD Software To Improve An Existing Identification Method

    Interested in improving a method using a QbD approach? This step-by-step explanation shows you how to use QbD software.

  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. Single Use Capacity Expansion

    Five key considerations for successfully creating cGMP single‑use biomanufacturing capacity.

  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. Here, a domain antibody (dAb) expressed in E. coli was recovered from fermentation broth. The dAb-containing sample was clarified (2.5-times concentration) and further washed with three wash volumes, with a recovery of approximately 90% of product in the permeate.

  10. Automated Ultrafiltration/Diafiltration Results In 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.