Search results for "development"
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Vaccine Development and Production Challenges Manufacturers
Vaccine development was discussed as important for global security at the World Economic Forum in Davos, Switzerland in January 2015. The first draft of the US House of Representatives “21st Century C…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
“They’re a very positive and big step forward for development of biosimilar products in the U.S.
Dr. Levine says there was nothing necessarily new or surprising about the guidelines. “I think t…
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Development of Purification for Challenging Fc-Fusion Proteins
…column steps for mAb purification that allow for the purification of similar molecules with minimal development and optimization.
In most two-column downstream processing platforms, the …
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Drug Discovery and Development in India
Changes in the regulatory environment in the same year led to other developments with the emergence of the country as a favorite destination for “chemistry” outsourcing followed by “collaborative drug…
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Top Tips for Successful Development of Antibody Chromatography Processes
First and foremost, because no drug development project ever presents without challenges, unfortunately, as we're all aware of, what types of challenges are you seeing associated with antibody therapi…
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Analytical Considerations for Successful Upstream Process Development with Spivey and Lane
…ioPharm International expert interview on analytical considerations for successful upstream process development. This interview, conducted independently by the editors of BioPharm International, is s…
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An Analytical Approach to Biosimilar Drug Development
As such, providing data on the physicochemical comparison between biosimilar and reference product becomes a primary consideration during biosimilar development (1).
Analytical chemists, howe…
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Critical Quality Attributes Challenge Biologics Development
By Susan Haigney
Critical quality attributes (CQAs) are used in biopharmaceutical development to gain an understanding of a product and the processes used to make that product. The International C…
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FDA Provides Guidance on Bispecific Antibody Development Programs
FDA published final guidance on May 24, 2021 to provide industry and stakeholders with recommendations for the development of bispecific antibodies including recommendations for regulatory, quality, n…
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Downstream Process Developers: What are Your Antibody Processing Challenges?
We’ll compile the responses and share our findings, along with tips to overcome these hurdles, in the Bioprocess Development Forum later this year.
The survey takes less than 5 minutes to complete.…