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Operational vision: Adoption of in-line monitoring and real-time release

Operational vision: Adoption of in-line monitoring and real-time release

Historically, the biopharmaceutical industry has relied on traditional pharmaceutical manufacturing practices to make and release products. This publication examines the future of biopharmaceutical manufacturing by presenting the vision of fully implemented in-line monitoring (ILM) and real-time release. This aspirational vision includes full ILM, predictive analytics and advanced process controls (APC) enabling release of product in real time, with concomitant predictive and preventative alerts and resolution of process, equipment and other production issues.

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Systematic assessment of process analytical technologies for biologics

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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Viral Clearance worst-case conditions presentation at PDA Viral Clearance conference

Ultra high concentration formulation

This member only survey covers the challenges of working with ultra-high concentration formulations, including; low dose volume products, viscosity aspects related to manufacturing and delivery, manufacturing and filling, automated screening, analytical challenges, osmolality considerations (hyper and hypo), syringeability, acceptable injection forces.

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Viral Clearance worst-case conditions presentation at PDA Viral Clearance conference

Referencing licence applications

A BioPhorum member resource  which captures journal or paper articles that BioPhorum members have successfully used in their clinical and license applications. The database captures: Process Stage Purpose Reference - submission section Paper Reference Comments The tool is available for members to use and the Phorum is encouraging their workstreams to add to it. DG hopes to see this list grow and become a useful resource to...

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Systematic assessment of process analytical technologies for biologics

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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