INSIGHTS ON DOWNSTREAM MANUFACTURING

• How To Optimize A Clinical Scale Manufacturing Process For Commercial Production

  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.

• Harnessing IMAC To Enable An Immobilized Enzyme Cascade For The Synthesis Of Islatravir

  In this talk, Jacob H. Forstater, Ph.D., Associate Principal Scientist, Merck Process Research & Development at Merck Research Laboratories will discuss how we utilized IMAC to enable a  streamlined through-process for the biocatalytic synthesis of islatravir, a promising nucleoside analog drug for the treatment of HIV. We discuss process design principles for the development and scale-up of robust multi-enzyme biocatalytic processes and their integration into traditional small-molecule manufacturing operations.  

• Two-Step Purification Using Mixed-Mode Chromatography

  In this study, Daniel Yoshikawa, Ph.D., Global Product Manager at Bio-Rad Laboratories, demonstrates an efficient purification workflow for a low-expressing recombinant protein. Multiple chromatography resins were screened for the capture step of this recombinant protein with goals to minimize fermentation dilution and increase purity and recovery to greater than 75%. Optimal wash and elution conditions were determined using a design of experiment (DOE) approach. An elution buffer containing NaCl and magnesium chloride was found to purify the target molecule with high recovery and purity.

• A Scalable Immobilized Metal Affinity Chromatography Media For Process Purification

  Downstream process purification of proteins requires a resin with optimized bead size for ideal pressure/flow properties and decent dynamic binding capacity DBC that provides production efficiencies and good process economics. This video explains how our newly developed metal chelate affinity resin — Nuvia IMAC — provides the mechanical strength, pore structures, ligand density, and particle size distribution required for an operation run at 300 cm/hr with a DBC of 40 mg/ml at 2 bar column backpressure.

• Increasing The Reach Of Cell And Gene Therapies

  4/29/2021

  The cell and gene therapy industry is rapidly evolving from the perspective of “can we commercialize this class of therapeutics?” to “how do we reach patients who need these therapies?”. However, the promise of these biologics can only be realized if the industry approaches manufacturing parity with monoclonal antibodies. A mixture of innovation and brute-force streamlining is needed to create viable cell and gene therapy templates. In this video, we discuss how upstream process optimization is ripe for innovative approaches.

• 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.

• Allegro™ Buffer Management System

  4/23/2021

  The traditional process buffer management workflow is a bottleneck in the manufacture of biotherapeutic drugs. Allegro™ Connect Buffer Management System provides in-line dilution of buffer at point-of-use.

• 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.

• Customizable Manifolds Solutions And Its Advantages

  4/20/2021

  In order to comply with the versatile requirements of today’s market, flexibility and the option to customize are key whilst maintaining availability and short lead times. This is true for many areas, not least when it comes to the ever-growing number of single-use technologies utilized in the biopharmaceutical industry.