Search results for " innovation" in Articles / App Notes
Article
Breakthrough Drugs Raise Development and Production Challenges
When the breakthrough program was established as part of the FDA Safety and Innovation Act of 2012, stakeholders envisioned about two to three designations a year. By the end of May 2015, FDA had rece…
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Elucidating Biosimilars Characterization
The global market for biosimilar drugs has been forecasted to be $2.445 billion in 2013 according to a report by the British market-research firm, Visiongain (1). The growth corresponds to a …
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Regulatory Challenges in the QbD Paradigm
…mited resources on both the industry and regulatory sides will be available for drug development and innovation.
In this 28th article in the Elements of Biopharmaceutical Production series, th…
Article
An Analytical Approach to Biosimilar Drug Development
Providing analytical data on the comparison between a biosimilar and the reference product is a primary consideration in the development of biosimilars.
By Feliza Mirasol
…
Article
Biopharma Seeks Balance
Investors are discouraged by the cost threat, so innovation is not sustainable, said Woodcock. If companies make pre-competitive advances on manufacturing processes, Marks noted, they can concentrate …
Article
Fluid Handling in Biopharma Facilities
Fluid Handling Innovation
BioPharm: What types of innovation would you like to see in the future of fluid handling systems?
Blomberg (Meissner): Specific to single-use systems, a lot of emphasis…
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Drug Discovery and Development in India
Arvind Pachhapur, country head, intellectual property and science and legal business of India Thomson Reuters says, “They include insufficient innovation, limited access to high risk funding, short su…
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Challenges and Trends in Biopharma Facility Design
Jornitz, president of G-Con Manufacturing about the challenges and innovations of biopharmaceutical facility design.
Challenges in Biopharma Facility Design
BioPharm: What top challenges do co…
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Biopharma Takes a Nervous Glance Over Its Shoulder
…harmaceutical products; a robust manufacturing workforce; and competitive state-level incentives for innovation.
However, the executives identified three other factors as crucial to bolstering…
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A Look Ahead at BioPharma Manufacturing and Regulation
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use …