PAT


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Systematic assessment of process analytical technologies for biologics

In order to evaluate the application of PAT tools to the development and commercialization of a bioprocess, BioPhorum conducted a benchmarking survey of biopharmaceutical companies and published the results in Biotechnology and Bioengineering journal. The results obtained in the survey can guide scientists and new manufacturers in terms of quality product development and all the stakeholders including funding agencies to assess the business value of tools and techniques employed during biologics manufacturing. This article published in Medicine Innovates is a synopsis of the paper

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Is it possible to do real-time analysis of aggregates in downstream protein solutions?

Eighteen BioPhorum Technology Roadmapping Phorum members (eleven end-users and seven supply partners) have joined forces to collaborate on a hands-on downstream proof of concept (POC) project. The practical POC work has just begun at Merck KGaA (Healthcare)’s Corsier-sur-Vevey site in Switzerland and will investigate the real-time analysis of aggregates content in protein solutions during the bind/elute cation exchange step of a mAb process. It...

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How to maximize business value from process analytical technologies

Applying process analytical technologies (PAT) for biotherapeutic development and manufacturing is possible because of technological, economic, and regulatory advantages across the industry. Typically, chromatographic, spectroscopic, and/or mass spectrometric sensors are integrated into upstream and downstream unit operations in‐line, on‐line, or at‐line to enable real‐time monitoring and control of the processes. However, despite their...

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Systematic assessment of process analytical technologies for biologics

To evaluate the application of PAT tools to the development and commercialization of a bioprocess, BioPhorum conducted a benchmarking survey of biopharmaceutical companies and published the results in Biotechnology and Bioengineering journal. Investigators assessed fifteen companies receiving seventeen responses from them and evaluated more than 20 different types of PAT tools in manufacturing using an industry-wide assessment to identify and rank the tools based on technological attributes such as technology maturity, ability to enable process control, and ease of implementation, as well as their business value such as simplicity of implementation, lead time, and cost reduction.

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In-line monitoring / real-time release testing in biopharmaceutical processes – prioritization and cost benefit analysis

The goals of an effective in-line monitoring and real time release testing (ILM-RTRT) and predictive modelling strategy are to leverage enhanced process understanding, risk mitigation and process control improvement to reduce the reliance on end product testing while improving early detection of catastrophic failure. Additionally, ILM and RTRT will enable cost reductions, product and process consistency and speed to market while enabling continuous improvement. But of the multitude of critical quality attributes and critical process parameters, which should be prioritized first for transition from off-line monitoring to in-line/on-line/at-line monitoring?

This paper not only answers the prioritization question but also provides supporting quantitative business case information along with technology-agnostic User Requirement Specifications (URS) for each of the attributes to serve as a guide for technology suppliers in the development of systems that will meet industry standards for ILM and RTRT.

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