By Herman F. Bozenhardt and Erich H. Bozenhardt,IPS-Integrated Project Services
In Part 1 of our article on biocontainment we discussed the history of biocontainment as an outgrowth of medical research, especially the effort to develop vaccines for various worldwide diseases. We provided some definition of the biosafety levels (BSLs) established by the Centers for Disease Control and Prevention (CDC) based on risk considerations. We also discussed the regulatory regime for biological agents and, specifically, for designing a facility for an FDA or EU regulated product within the confines of the safety practices dictated by the CDC and design requirements of the NIH.
Application Note |
By Xuemei He, Louisa Vang, Mark Syder, Payal Khandelwal, and Daniel Yoshikawa,Bio-Rad Laboratories, Inc.
A hydrophobic anion exchange mixed-mode resin has been developed to overcome challenges in antibody purification. This application note describes the purification of acidic and basic antibodies using this mixed-mode chromatography resin through bind-elute and flow-through modes of purification.
Case Study |
By Ranjeet Patil and Mochao Zhao,MilliporeSigma Cell and Gene
The production of viruses, whether for use as viral vaccines, viral vectors for gene therapy, or oncolytic applications, requires complex processes that can translate into high costs, as well as slow development timelines and time-to-market. This article presents several case studies highlighting the advantages of process intensification using Natrix single-use membrane chromatography to increase your productivity and reduce your capital and operational manufacturing costs.
Challenges of T-cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T-cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.
In this age of digitization, many pharma and biotech companies still struggle to gain senior level buy-in for investments in manufacturing IT. This white paper covers major saving areas with MES as well as typical steps to evaluate ROI.