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AI Algorithm Qualification for Pharma Manufacturing

1 August 2020

How GxP-Compliant SaaS Platforms Facilitate the Process Explore a Quality by Design (QbD) approach to applying Artificial Intelligence (AI) in pharma manufacturing; and demonstrates how GxP-compliant AI software can be leveraged to qualify AI algorithms...

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Mass Balance & Material Flow Rates in Pharmaceutical Applications

1 August 2020

Coriolis versus Saw Principle – a Comparison: A Revolution in the Field of Flow Measurements? In the pharmaceutical industry, the flow rate of various media needs to be measured precisely. The spectrum ranges from highly viscous intermediate products to...

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Microbial Contamination Risks & Preventing Them with Real-Time Analysis

1 August 2020

Microbial contamination is the biggest risk that faces the pharmaceutical industry today in terms of making products that meet safety, quality, and efficacy requirements. A couple of the many risks associated with microbial contamination in...

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Upstream Intensification – Enabling Perfusion Processes with Cell Retention Technologies

1 July 2020

Perfusion processes offer key advantages to fed-batch processes and are now possible thanks to recent advances in cell retention technologies, cell line, and media development. What features should such technologies have to achieve performance,...

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Data Integrity: How to Prevent a Significant Source of 483 Warning Letters in Drugs, Devices, and Biologics

1 July 2020

5 Practical Ways to Proactively Avoid Data Integrity Issues for Improved Quality Pharmaceutical and biotechnology companies are no strangers to FDA 483 warning letters. In fact, the categories of Devices and Drugs accounted for the second- and...