{"id":4581,"date":"2018-01-29T13:30:00","date_gmt":"2018-01-29T13:30:00","guid":{"rendered":"https:\/\/www.waters.com\/blog\/biopharma-data-chaos-or-harmony\/"},"modified":"2022-07-28T03:08:40","modified_gmt":"2022-07-28T03:08:40","slug":"biopharma-data-chaos-or-harmony","status":"publish","type":"post","link":"https:\/\/www.waters.com\/blog\/biopharma-data-chaos-or-harmony\/","title":{"rendered":"Biopharma Data: Chaos or Harmony?"},"content":{"rendered":"

When the key to your biologic\u2019s success is locked in its data<\/h2>\n

To get the most out of recent innovations in biopharmaceutical development and QC such as multi-attribute monitoring (MAM), it\u2019s time to better connect the systems that manage biopharma data. This series explores the what, the why, and the how of better biopharma data. <\/em><\/p>\n

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Imagine a biopharma nightmare scenario: You are developing a large-molecule drug, a therapeutic monoclonal antibody (mAb). With strong phase three clinical trial results, your molecule looks promising. Simply getting this far means your molecule has already beaten the odds, succeeding past a point where hundreds of others have failed. To cross the finish line, you\u2019re preparing for commercial production. Tens or hundreds of millions of dollars are on the line.<\/p>\n

Then an artifact shows up in your QC data.<\/p>\n

One product attribute is unexpectedly out of range. Your drug sits on the launch pad while you must find out why. Is it the product itself? A raw material? An assay or instrument used in your quality system? Weeks or even months can pass as you investigate the answer. If your drug has blockbuster potential, every day wasted could amount to $10 million or more of lost sales.<\/p>\n

Time and money are of the essence, and you\u2019re losing both. Since mAbs are inherently complex molecules, and the biological processes used to produce them have so many variables, how do you not get tripped up by this variability as you race to the finish?<\/p>\n

The answer is in your data. If data can throw your development program into chaos, it can also help move you forward.<\/p><\/blockquote>\n

Let\u2019s see how.<\/p>\n

Terabytes of data, all for one drug<\/strong><\/h3>\n

With biologics, the process is the product. In other words, since it\u2019s challenging to fully characterize as large a molecule as a mAb, you control the quality of your drug by controlling how you make it. And you control that process through the data you gather about it\u2014ultimately, understanding process parameters and their effect on the product\u2019s critical quality attributes (CQAs).<\/p>\n

To meaningfully comprehend these factors results in gigabytes of analytical data per day, terabytes per month, all of it accessible to regulators and in-line with their requirements. And, since drug development takes place over years, this large, constantly growing body of data spans multiple touchpoints:<\/p>\n