Search results for "biopharma"
Article
Applying GMPs to the BioPharma Supply Chain
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be available when needed, effective for their intended purpose, and safe to use. At an operational level, it is v…
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Trends in BioPharma Approvals in 2013
A total of 16 approvals were recorded in Europe, while only six biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in th…
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A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
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Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
…g to apply quality-by-design (QbD) methods and process analytical technology (PAT) underpinnings to biopharmaceutical development and manufacturing. As Jose Menezes, CEO of 4Tune Engineering, pointed…
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The Value of Digital in Biopharma
To be successful in making targeted therapies, biopharma manufacturing must evolve into smaller, faster, and more efficient environments. Digital technology and data science can be leveraged to add …
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The Pulse on the Industry - BioPlan and the Biopharma Resilience Index
This podcast is an informative and accessible discussion on the biopharma industry’s needs and possible solutions being taken to address these issues.
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Fluid Handling in Biopharma Facilities
By Susan Haigney
Contamination prevention in biopharmaceutical manufacturing is crucial, and the proper handling and storage of fluids is essential to limit the possibility of contamination. Facili…
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Continued Process Verification for Biopharma Manufacturing
A group of more than 20 companies collaborated on this topic, using the facilitation services of the BioPhorum Operations Group (BPOG), to generate a detailed example of how CPV for a biopharma manufa…
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Emerging biopharma: progressing a biologic drug to market
There are many pitfalls in the road to developing and bringing a new therapy to market. Understanding some of these areas and being prepared to make the right decisions at the right ti…
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A Stepwise Approach to a Digital Transformation in Biopharma
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An interview on “smart” manufacturing—a paradigm shift towards digital transformation for improved safety and quality, optimized performance, and increased complianc…