Search results for " information"
Article
The Need for Advanced Process Modeling for New Therapeutic Biologics
For example, the bioprocess model would have to capture relevant information consistently as well as thoroughly to allow both researchers and IT developers understand the process requirements. The mod…
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Cell-Culture Advances Test Bioreactor Performance Models
In addition, the information systems technology used has been validated and demonstrated to be cost effective, secure, compliant, and scalable with the volume of data generated from manufacturing proc…
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Moving PAT from Concept to Reality
The more information that a company has about its processes, the better decisions it can make, such as about whether to scale up in single-use or stainless-steel equipment,” he explains.
But barri…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and en…
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Supply Chain Challenges for Single-Use Systems
Suppliers address the complexity of supplying disposable components to the global biopharmaceutical manufacturing industry.
By Jennifer Markarian
The implementation of sing…
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The Challenge of Disruptive Technologies in Bioprocessing
The use of an advanced digital environment where the analytical data are transformed into information and informed decisions, and then into process knowledge and an ability to predict process performa…
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Navigating Data Integrity in the Modern Lab
At each step along the way, the process must be validated to ensure that the integrity of the data, and the digital thread of information, is preserved. Recently, the trend has been toward consolidat…
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Techniques for Improving Process Development for Exosome-Derived Therapeutics
These native information carriers between cells and tissues can be used by drug developers to deliver payloads to recipient cells and alter the biology of recipient cells as part of the communication.…
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Best Practices for Data Integrity
You also need to validate the solution and make sure that your supporting documentation aligns with the new way you record information. The actual audit procedure is fairly similar to audits of paper-…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
The ETT’s role, as defined in the draft guidance, is to answer sponsor questions about information FDA expects to see in a submission and to facilitate regulatory review of a new manufacturing technol…