BONADUZ, Switzerland, June 15, 2023 /PRNewswire/ — Hamilton has just released a comprehensive new white paper, “Biopharma PAT: Downstream Critical Process Parameters.” This whitepaper serves as a powerful resource for biopharma manufacturers seeking to design efficient and robust DSP processes and ensure product quality, safety, and efficacy in biopharmaceutical production. The document is compelling for downstream skid-builders as well with multiple real-life examples provided.
During the production (upstream) and successive purification and concentration (downstream) of biopharmaceuticals in a GMP environment, each product must retain the expected biological activity and potency in its intended therapeutic application. By defining their critical quality attributes (CQAs) and controlling the corresponding critical process parameters (CPPs) with appropriate process analytical technology (PAT), the biopharma manufacturers can achieve such a goal.
Process control requires in-line process monitoring. In downstream processing, however, in-line monitoring can pose significant systems design challenges. In this white paper, Hamilton explores the CPPs which are mandatory to control for each unit operation of the DSP skid train, such as: buffer preparation/dilution, protein A and IEX chromatography, filtration, and virus inactivation. In-line sensor management tips and examples are provided to help manufacturers implementing such systems achieve the highest measurement accuracy.
“We often see our customers in biopharmaceutical manufacturing grapple with how best to choose and implement PAT that are both robust in scope and efficient in use,” states Giovanni Campolongo, Senior Market Segment Manager Biopharma. “With this white paper, we seek to shed light on these systems as well as provide examples and actionable information for implementing in-line sensors to monitor downstream processing. The report is sure to become an indispensable resource for our current and prospective clients.”
To access the whitepaper, visit https://www.hamiltoncompany.com/biopharma-downstream-white-paper
About Hamilton:
Hamilton is a leading global manufacturer, providing automated liquid handling workstations, laboratory automation technology, and process analytical sensors to the scientific community. With a focus on innovative design, the Hamilton product portfolio includes liquid handling platforms, standard application-based solutions, small devices, process sensors, consumables, and OEM liquid handling solutions.
Known for advancing the life science, clinical diagnostics, forensics, biotechnology and biopharma industries, Hamilton products offer reliability, performance, and flexibility. Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland as part of their continuous commitment to quality and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world.
www.hamiltoncompany.com
Media Contact:
Sissy Kephart
1 (775) 858-3000
[email protected]
SOURCE Hamilton Company
