The webinar will look at the challenges of implementing a GMP compliant Quality Management System for chromatography products. Although the chromatography products manufactured by Astrea Bioseparations are not regulated we understand that our products are critical to our client and have the potential to impact the Quality of the plasma-derived therapeutics. In the Webinar Colin Grant, Director of Quality & Regulatory Affairs, will go through our continuous process improvements from the implementation of clean rooms to developing our Quality Management System in line with GMP for API guidelines according to Rules and Guidance for Pharmaceutical Manufacturers and Distributors. This webinar is a beginning of a set of training programs where we will break into greater detail how we implemented processes that support our QMS including Risk assessments, Root Cause analysis and Implementing an Electronic Quality Management System.
Most Recent Videos
2:03Watch how easy it is to change out the wetted parts on the new 45cm diameter column.
31:00Astrea Bioseparations Webinar#6 - The Role of Process Development in Chromatography
17:53A review of pre-packed EvolveD™ column technologies from Astrea Bioseparations, providing ready to use GMP columns. An open platform suitable for any Bioprocess chromatography media.
31:10Learn about the importance of removing residual Endotoxins from Biopharmaceuticals and the associated challenges this brings.
35:20Learn about the use of Astrea's Multi Mode Mimetic Ligand Library and what happens after you get an initial hit.
43:32Dr. Steven J. Burton reviews the challenges faced in biomanufacturing and how Astrea Bioseparations can help overcome many of them through their Discover, Develop, Deliver services.
11:39Learn about the challenges facing Biomanufacturing and how Astrea Bioseparations can help overcome many of these through their Discover, Develop, Deliver services.
4:54Evolve Process columns have a unique feature in that all wetted parts can be replaced using a Refresh Kit, making the columns semi-disposable, eliminating the need for clearance and cleaning validatio
5:05A presentation on Astrea Bioseparations' Multi-Mode Mimetic Lingand™ Library. A novel screening tool with 96 different Affinity/ Multi-Mode ligands designed to bind either target or impurities without
3:20Now you can screen you feedstock against a library of 96 adsorbents to see which bind the target molecule or impurities without adjusting the feedstock conditions.
2:14Follow the expansion of Astrea Bioseparations adsorbent manufacture plant on Isle of Man. which has created capacity to deliver batch sizes up to 1000L and over 40,000L per annum.
21:55Affinity chromatography has a long history of use in bioprocesses and is a powerful tool in making industrial processes more efficient by reducing the number of steps necessary to achieve the desired
41:43In 2019 Astrea Bioseparations took part in BioProcess International Digital week. You can catch up on demand here.
21:08Multi-mode chromatography has come to prominence in recent years due to the general utility of multi-mode ligands for product capture and polishing. In particular, their application in flow-through po
56:06Astrea Bioseparations Digital Week Webinar 2018 in collaboration with BioProcess International.