Search results for " facility"
Article
Getting a Handle on Biopharma’s Most Critical Quality Attributes and Quality Control
In the end, the business case for in-line testing and RTR will depend on the individual facility’s requirements, a cost vs benefits analysis, and operating costs, Adkins said. So far, however, researc…
Article
What’s New in Upstream Technologies
The company also reports that it supplies process buffers at a fraction of the resources and facility space, resulting in a more streamlined buffer suite and a more efficient manufacturing process. Th…
Article
Perfusion Culture Using TFF or ATF as Cell Retention Method
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Perfusion processes have many advantages such as being favorable for product quality and supporting efficient facility utilization by offering the possibility…
Article
Achieving Process Balance with Perfusion Bioreactors
…, in which bioreactor farms consisting of many dozens to hundreds of bioreactors are operated in one facility, according to Adams.
Stainless steel vs. single use
Long process durations, high …
Poster
Opportunities, Challenges, and Economic Drivers for Start-to-Finish Continuous Biomanufacturing
Continuous unit operations have been used successfully in manufacturing of several approved products with a collective revenue of $25 billion annually. Many large biopharmaceutical organizations are…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
More consistent and reliable production processes are critical for advancing innovative treatments.
By Jill Wechsler
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Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Ensuring Viral Safety of Viral Vaccines and Vectors
Viral vaccines and viral vectors used in biotherapeutic applications carry the risk of microbial contamination, which must be addressed.
…
Article
Optimizing Late-Stage and Commercial Cell-Culture Processes
… increasing titers, maintaining consistent product quality, reduced cost of goods, and a decrease in facility footprints, Laird says.
Cell-culture hurdles
The ability to maintain a reliable s…
Article
Biopharma Seeks Balance
Biopharma Seeks Balance
Biopharma companies can balance competing demands from patients, investors, and regulators by keeping a focus on science.
By Rita C. Peters
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Article
Understanding Validation and Technical Transfer, Part 2
Understanding Validation and Technical Transfer, Part 2
A validation plan developed to support a process unrelated to bio-pharmaceutical manufacture is applied to biopharmaceutical processes and sys…