Search results for " industry" in Articles / App Notes
Article
The Outlook for CMO Outsourcing in 2019
Rader
Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial API and biopharmaceutical product ma…
Article
Scaling Up Novel Therapies
Within the past decade, however, the industry has achieved significant improvement by adopting technologies that allow more predictable outcomes, says Alex Chatel, product manager at Univercells. Bior…
Article
Unifying Continuous Biomanufacturing Operations
However, there are vendors that are now investigating column sterility, says Bonham-Carter: “Long-term life of the columns is a current topic of conversation in the industry, and Repligen has been exa…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
Yet, there is increasing pressure on the industry to reduce the price of these drugs. One possibility is in the development of biosimilar products. President Trump has promised to repeal and replace t…
Article
The Tide Stays High
…ly-financed companies, the negative energy surrounding emerging bio/pharma did not bode well for the industry.
The valuations and levels of public offering activity in 2014 and 2015 were not sust…
Article
CMOs Concerned With Cost of Single-Use Equipment
In fact, according to the latest industry study from BioPlan Associates (1), there appears to be one aspect of single-use application that CMOs feel is inhibiting adoption: The cost.
As part of th…
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Quality Systems Key to Lifecycle Drug Management
FDA issued a guidance in March 2014 that sought to expand the range of manufacturing changes that can be documented in annual reports, but the list was fairly limited, and industry has found it incons…
Article
Modular Manufacturing Platforms for Biologics
“Over the past 10–15 years, the industry has been experimenting with various ways of incorporating modular design into project delivery of capital programs,” says Emel. “Modular design of process syst…
Article
Re-use of Protein A Resin: Fouling and Economics
While all five of the parameters are used in the industry, yield is considered as the most important, followed by impurity levels, product quality, chromatographic profile, and HETP. Other than these …
Article
New Era for Generic Drugs
8-10
The 30th anniversary of the Hatch-Waxman Act in September generated widespread recognition of how the legislation created today’s vibrant generic-drug industry. Generic drugs now account for m…