Search results for " pharmaceutical"
Article
Can Vaccine Development Be Safely Accelerated?
The DNA approach against COVID-19
San Diego-based Inovio Pharmaceuticals is one company developing a DNA-based vaccine against COVID-19. The biotech was the first to advance a vaccine (INO-4700) a…
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
…with McDonnell Boehnen Hulbert & Berghoff LLP (MBHB) and chair of the firm’s biotechnology and pharmaceuticals practice group, based in the United States; Daniel Rooke, partner with Start Codon in th…
Article
Driving Improved Access to Biosimilars
Driving Improved Access to Biosimilars
New guidance from FDA, including standards for interchangeability, is expected to speed development of biosimilars, but experts warn against oversimplifying ri…
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Automating the Biomanufacturing Process
As robotic systems become more accessible and less expensive, Lebl sees them playing a bigger role in pharmaceutical manufacturing, especially for material movement.
Besides data storage, analytic…
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Biomanufacturing: The Cost of Unskilled Workers
First, a 2018 report from BioPlan Associates estimates there are well over 10,000 therapeutics in R&D, both drugs (chemical substance pharmaceuticals) and biopharmaceuticals (biotechnology-derived pha…
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Ensuring Viral Safety of Viral Vaccines and Vectors
Remove or inactivate viral contaminants downstream
Regulatory bodies require that the purification process for a biological pharmaceutical removes any nonproduct virus. These “viral clearance” or …
Article
Automation Trend in Fill/Finish Reduces Contamination Risk
Handling sterile liquids in the pharmaceutical industry has traditionally relied on consistent techniques over the past 100 years, and changes in technology and regulations have been relatively slow, …
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CDMOs Driving Emerging Bio/Pharma Success
CDMOs Driving Emerging Bio/Pharma Success
CDMOs can claim credit for the robust growth of emerging bio/pharma financings.
By Jim Miller
Emerging bio/pharmaceutical companie…
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Applying GMPs in Stages of Development
In today’s pharmaceutical environment, it is not uncommon for more than one company to be involved in the development of a product. Virtual companies may use the services of a contract laboratory, a c…
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Navigating Data Integrity in the Modern Lab
Navigating Data Integrity in the Modern Lab
The importance of both technology and people in the modern laboratory.
By Amber Lowry
Understand…