Thursday, December 8, 2022 Daily Archives

Ensuring Single-use Systems Integrity in Aseptic or Closed-Process Applications

Due to their numerous benefits, single-use systems (SUS) have been increasingly implemented in biopharmaceutical processes in the past decades. Originally used in applications for the preparation and storage of buffer and media, SUS have become more and more important in the commercial production of biopharmaceuticals. Today, biopharmaceutical manufacturers use this technology in critical drug substance or drug product process steps such as formulation, bulk storage, bulk transport, and final filling of drug product. By using single-use technologies, manufacturers can reduce…

Purity by Design

After launching Nereus LentiHERO, a game changing fit-for-purpose solution for lentiviral vector purification in 2022, Astrea Bioseparations present this end of year report with a selection of interviews, application notes, and articles. Identifying the gaps in lentiviral purification, they discuss how to increase processing efficiency, purity, and recovery of LVV particles. They also look towards the future to bring a radical change in bioprocessing for cell and gene therapies. The Nereus LentiHERO spin column is the first product in a…

From Concept to Cure: Using AAV in Gene Therapy

Because viruses efficiently insert nucleic acids into host cells upon infection, they are attractive vehicles for gene delivery. In the past, many viral gene delivery agents were unsuitable for clinical applications due to their high immunogenicity and propensity to cause cancer. To bring gene therapy to the clinic, scientists now use adeno-associated viruses (AAVs) for safe and effective gene delivery. Download this ebook from Bio-Rad to learn about Techniques for developing safe and effective AAV vectors for gene therapy Characterizing…

The CDMO space does not have the capacity to meet fill-finish demand, says Lonza

Pipeline expansions are placing pressure on fill-finish capabilities and have caused a surge of investment in infrastructure, says Peter Droc, head of drug product services at Lonza. Swiss contract development manufacturing organization (CDMO) Lonza has made a string of investments to bolster its fill-finish capabilities. In July 2022, the firm forked out $521 million to construct a commercial large-scale fill-finish facility at its site in Stein, Switzerland. And less than a year before this – at the same plant –…

Polyplus adds plasmid DNA CDMO Xpress Bio to upstream toolbox

Polyplus tells us how such additions as plasmid DNA maker Xpress Biologics bolsters its upstream offering and can help reduce the costs of cell and gene therapies. The deal sees cell and gene therapy upstream solutions firm Polyplus add Belgian contract development and manufacturing organization (CDMO). Financials have not been disclosed, but the acquisition brings plasmid DNA and protein production using microbial expression systems to Polyplus’ engineering technology and services portfolio and will bolster the firm’s ambition to improve gene-therapy…