DOWNSTREAM PROCESSING WHITE PAPERS & CASE STUDIES

• Important Considerations For Implementing A Single-Use Biomanufacturing Strategy

  Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

• SciLog - Creating Advanced Biotech Equipment With Mettler Toledo For nearly two decades, SciLog, Inc. has been dedicated to creating revolutionary single-use purification systems and disposable sensor technologies.
• White Paper: Comparability Of The Cell-Freeze® (Charter Medical) Freezing Bag To The Cryocyte™ (Baxter) Bag For Cryogenic Storage Of Human Hematopoietic Progenitor Cells Successful cryopreservation of hematopoietic progenitor cells (HPC) is dependent upon a number of factors, including the biopreservation media, freezing rates, and storage using sterile, cryogenically durable storage bags. The Cell-Freeze® cryogenic storage containers are 510(k) cleared for storage, preservation and transfer of hematopoietic progenitor stem cells (HPC’s). By Charter Medical, Ltd.
• Avoiding Drug Shortages With Microbial Detection

  Over the past year, critical drug shortages used to treat a host of life-threatening illnesses have been making headlines. Microbial contamination has been cited as a major contributor to the shortage, yet the prevailing practices to ensure the safety of drugs have been slow to change. In most cases, quality assurance practices safeguarding the drug making environment continue to rely on periodic air and a culturing method from a prior century. By Aric Meares, President and CEO, BioVigilant

• Rapid Screening Of A Cell-Based Assay For GLP-1 Receptor Using A Natural Product Library

  Here we demonstrate the detection of GLP-1R binding through the incorporation of a homogeneous cell-based binding assay using HTRF Tag-lite® technology. By Brad Larson and Peter Banks, BioTek Instruments, Inc. and Nicolas Pierre, Suzanne Graham, Jean-Luc Tardieu, and François Degorce, Cisbio US, Inc.

• Sani-Tech® Ultra White Paper

  For several years, pharmaceutical manufacturing professionals have increasingly stated concerns about material leachables and extractables and their impact on the products they produce. Fluid transfer systems that include flexible tubing have been at the forefront of this discussion.