As apheresis centers look a few years into the future to offering perhaps 15-30 approved medicines, and hundreds more clinical trials, this current situation will very soon become untenable.
Polysorbate-80 (PS-80) is a surfactant commonly used as an excipient to improve API stability. However, degradation of PS-80 can lead to decreased drug potency or stability, and there is inconsistency in the quality and composition of PS-80 provided by different vendors.
For most cell and gene therapy products, a 14-day testing period for sterility is too long and hinders the timely release of products with a short shelf life or a small window for release to the clinic. Download this white paper to learn how validated, rapid sterility methods better address the needs of cell and gene therapy clients, with faster turnaround and increased throughput.
This application note proposes an alternate but equally effective approach to biosimilar purification, by substituting a less expensive ion exchange resin for the affinity capture step.
Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.
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.
An overview of how CDMOs can help companies get started in the world of CGT manufacturing, with considerations around timing of engagement to maximize commercial and clinical success.
The advent of CRISPR as a gene editing tool continues to revolutionize drug discovery and development.
Obtaining primary human NK cells at clinically relevant scale is challenging. Find out how you can generate 109 cells using a xeno‑free NK cell expansion and several automated and functionally closed unit operations, suitable for cGMP environments.
Effective viral clearance studies remain one of the challenges facing manufacturers of biologics. These studies are an essential part of process validation and are critical to ensure drug safety. This article provides the basics of what you need to know when studying virus reduction of a chromatography step.
Integrated single-use freeze-thaw assemblies with reliable component parts, such as the connectors supplied by CPC, have become the primary implementation choice for achieving successful drug substance transfers between manufacturing facilities.
Download this free collection of articles and learn how to let go of legacy aseptic filling line equipment, seven common filling blunders and how to avoid them, nontraditional design concepts for CAR T processing, what to do when your isolator is taking too long to de-gas. Herman and Erich Bozenhardt bring a collective 54 years of bioprocess facility design and production experience to the pages of this comprehensive ebook.More Content Collections