Search results for " industry" in Articles / App Notes
Article
Emerging Therapies Test Existing Bioanalytical Methods
The May 2018 FDA Bioanalytical Method Validation (BMV) Guidance for Industry (2) provides general guidelines for all bioanalytical assays but lacks any specifics on assays that use flow cytometry, PCR…
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A Look into the Future of Biopharmaceutical Quality
Quality regulations, and industry, may have to continually adapt to address these challenges.
To gain perspective on what the future holds for biopharmaceuticals and how the industry and regula…
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The Metrics of Quality Culture
The official title of this guidance for industry is Request for Quality Metrics, Guidance for Industry (1) and its potential release has been looming on the horizon since 2012.
The intent of FDA t…
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Continuous Manufacturing: A Changing Processing Paradigm
“About five years ago, as the industry matured, the manufacturers were focusing on flexibility, cost, and capital efficiency in manufacturing,” he says. “It was at that point that continuous technolog…
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Biopharma Takes a Nervous Glance Over Its Shoulder
The US biopharmaceutical industry’s status as the global leader in innovative biopharmaceutical R&D is not guaranteed. Both R&D and manufacturing could shrink or shift to other countries if the busine…
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
In addition, a poster session allowed for an open discussion around some of the latest trends and innovations within the industry in combination with excellent networking opportunities.
The me…
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Optimizing your Cell Culture Process to Improve Productivity
Other companies that we support are in the cell and gene therapy industry. The companies that support biopharma’s such as contract manufacturing organizations or CMOs are participating in cell line or…
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Track-and-Trace Progress Benefits Supply-Chain Security Efforts
“[In the US,] we have been supporting the [pharmaceutical] industry for the final milestone, the Drug Supply Chain Security Act (DSCSA) deadline of November 27, 2023,” says Sturtevant, and advances ha…
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Technology Innovations Improve Process Chromatography Performance
Current challenges
The biopharmaceutical industry continues to face technical and logistical challenges in process chromatography, particularly during scale-up. Although significant work has been …
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Mechanistic Modeling: Current Advantages and Future Opportunities in Biopharmaceutical Process Development
How do you believe mechanistic modeling in process development will develop in the future?
Mechanistic models are already considered being a game changer for the industry and their applications wi…