Wednesday, August 9, 2017 Daily Archives

Effective Viral Clearance in mAb Purification Using TOYOPEARL® Resins

Impurities such as viruses are typically present during the manufacturing of biological drugs. The viruses may be present in the unprocessed material from the upstream collected harvest, such as released from cell culture media (endogenous) or accidentally introduced during processing (adventitious). Viral clearance is required by the FDA and international regulatory bodies as specified in the ICH Q5A documents. In this study we evaluated two chromatography steps in the purification of a monoclonal antibody (MAb) for viral clearance. Evaluation was…

Identification of Process Parameters Which Underpin Robust Platform Production Processes

Critical objectives for the biopharmaceutical industry are the creation of robust, reproducible processes which result in consistent critical product quality attributes and yields. To meet these requirements within a short time period it is important to apply platform production processes which consist of a common host cell line, expression vector, cell line development process, cell culture media/feed, process control and scale-up methodologies during cell line development, process characterization and cGMP manufacturing. In this study we integrate mathematical based approaches with…

Collaborating to Address the Bioburden Challenge

Bacteria and their byproducts can negatively affect the safety and potency of a biopharmaceutical drug. At a minimum, bioburden contaminations lead to reduced productivity as a result of lost batches and/or deviation investigations. Striving towards a bioburden-free process, biopharmaceutical companies and their suppliers must collaborate. To meet this challenge, GE Healthcare is committed to continuous improvement of its chromatography resins to enable delivery of products without detectable bioburden. For example, development of Protein A resins to withstand high NaOH concentrations…

Purification of Antibody Fragments with Amsphere™ A3 Protein A Resin

The binding mechanism between the engineered C domain of the Amsphere™ A3 protein A (PrA) ligand and a VHH single domain antibody (sdAb) was revealed. Binding sites in the PrA ligand in helices 2 and 3 and in framework regions 1 and 3 of the VHH were confirmed. Identified VHH residues are not involved in antigen recognition. Overlap with a human VH showed the same interaction sites. These results provide insight on why Amsphere A3 is a suitable tool for…

Modular, Single-Use Facilities Increase Biomanufacturing Flexibility

The pipelines of biopharmaceutical companies are becoming increasingly diverse while improvements in cell lines are leading to more productive bioprocesses. These factors are driving new capacity demands for bio-pharmaceutical companies and their CDMO partners. It is becoming increasingly important, therefore, that companies implement innovative, highly efficient, flexible facilities that are capable of meeting these challenging capacity demands. Login to view full PDF version of poster.

ANGUS Life Sciences Expands U.S. Biotechnology Commercial Team

ANGUS Life Sciences, a business of ANGUS Chemical Company, and the world’s only fully integrated manufacturer of TRIS AMINO™ tromethamine buffers, has announced the addition of five regional account managers to cover the U.S. biotechnology and pharmaceutical markets. The new team bring decades of combined industry experience and are playing an essential role in further developing relationships with leading biotechnology and pharmaceutical manufacturers. “The expansion of our Life Sciences team reflects our dedication to providing customers with the highest-quality production…