Search results for " industry"
Article
FDA Framework Spurs Advanced Therapies
One such approach involves the use of common manufacturing protocols within academia and industry to allow the sharing of clinical trial data.
The framework also implements the Regenerative Med…
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Process Chromatography: Continuous Optimization
Process development scientists must also balance multiple factors when developing new processes to address current challenges and industry demands. “Capacity, resolution, and the speed at which the pr…
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Automating Bioprocesses
The industry is still at an early stage, but companies are beginning to do multivariate modelling and gaining the processing knowledge needed for effective continuous manufacturing.
BioPharm: How …
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Ensuring the Biological Integrity of Raw Materials
Single-use manufacturing devices, disposable consumables, and ready-to-use reagents and media are also reducing rates of contamination in the industry.
Faster, more accurate tests are being introd…
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Process Chromatography Selection for Downstream Processing Applications
By Caroline Hroncich
Process chromatography has changed significantly since it was first introduced to the biopharmaceutical industry. Important factors such as column design, resin development, a…
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Design and Qualification of Single-Use Systems
While the word qualification is not specifically mentioned in 21 CFR 211, the interpretation of these regulations by both industry and regulatory agencies has introduced terms such as design qualifica…
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Best Practices in Qualification of Single-Use Systems
The technology is still evolving, and the industry can expect further advances in the future.
The dynamic nature of SUS provides excitement for professionals from both suppliers and end users, who…
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Use of Multivariate Data Analysis in Bioprocessing
The biopharmaceutical industry, however, has accrued greater benefits as evidenced by publications highlighting the use of MVDA tools both in upstream as well as downstream processes (9). This is in p…
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Drug Discovery and Development in India
Market opportunities
Despite these challenges, industry players can still explore opportunities in the local business environment. Driving these prospects includes the country epidemiological tran…
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Quality by Design and Extractable and Leachable Testing
FDA Guidance for Industry, Q8 (R2) Pharmaceutical Development describes the elements of QbD used in pharmaceutical development (2). The guidance outlines a series of proactive steps used to build qual…