Search results for " industry" in Articles / App Notes
Article
Understanding Validation and Technical Transfer, Part 3
This third article in a three-part series (1,2) dealing with validation and technical transfer in the biopharmaceutical industry discusses validation of a non-traditional biopharmaceutical process, l…
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Putting Viral Clearance Capabilities to the Test
“A lack of appropriate scale-down models and strategies to support changes in industry practices such as continuous processing can restrict the design of the viral clearance study,” Smith says. “As ne…
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Applying GMPs in Stages of Development
The process used in the industry to determine root cause is, of course, the investigation procedure. This procedure, regardless of whether the product you are investigating is biotech or traditional, …
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ADC Development Robust Despite Lackluster Performance
This has led to an unfavorable attitude toward ADCs for some industry participants. Overall, however, the industry continues to believe in the clinical benefits of these drugs (1). Some examples of AD…
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Modeling and Miniaturization: Key Topics at Successful HTPD Conference
Ottens reviewed how knowledge-based chromatographic process development based on mechanistic modeling will become more important and more utilized in the industry in the coming years. He also emphasiz…
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Best Practices for Data Integrity
Best Practices for Data Integrity
Optimize practices and meet requirements using electronic data integrity systems.
By Jennifer Markarian
Maintainin…
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Managing Risk in Biomanufacturing
With patients’ lives dependent on a continuous supply of high-quality drugs and vaccines, it is essential to have consistency within the industry on how to manage risks. Today’s business environment r…
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Fusion Proteins Pose Manufacturability Challenges
… half-life,” explains Steven Chamow, a principal with Chamow & Associates, a biopharmaceutical industry consultancy.
Specifically, two or more proteins are joined in one polypeptide chain, in som…
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Critical Quality Attributes Challenge Biologics Development
BioPharm: As biologics become more popular in the industry, are companies paying more attention to risk assessment and QbD for these products?
Das (BMS): Generally, yes. Risk assessment still diff…
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Speed and Flexibility Are Dual Goals for Biopharma Operations
To assist the adoption of single-use systems, industry organizations, such as the BioPhorum Operations Group and Bio-Process Systems Alliance, are addressing concerns about extractables and leachables…