Intensification of Influenza Virus Purification: From Clarified Harvest to Formulated Product in a Single Shift

In this report we describe processes for purification of influenza A and influenza B, using a single chromatography step with a cation-exchange monolith on a single-use basis.

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Cell Culture Media: An Active Pharmaceutical Ingredient or Ancillary Material?

Although the industry refers to cell culture media as neither APIs nor significant structural fragments of APIs, determinations about whether cell culture media should be considered raw materials or ancillary materials have been inconsistent.

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Using Data and Advanced Analytics to Improve Chromatography and Batch Comparisons

How Bristol-Myers Squibb leveraged its OSIsoft PI System data infrastructure with the Seeq advanced analytics application to analyze data for batch processes and scale-up to improve production efficiencies.

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A Novel 3D Culture System for High-Throughput Hepatoxicity Screening

Before developing the hepatotoxicity assay to evaluate the drug's cytotoxity on HT-29 colon carcinoma cells, the authors implemented and validated use of a customized, ultralow-attachment spheroid plate which enabled a 3D viability assay.

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Proposing a Systematic QbD Approach Toward Validated Guidelines for CMO RFI and RFP Processes: Biopharmaceutical Vendor Evaluation and Selection Minimum Standards (BioVesel)

The biopharmaceutical vendor evaluation and selection minimum standards (BioVesel) was created due to the lack of harmonized processes and standards to support evaluation and appointment contract manufacturing organizations.

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