Search results for " innovation" in Articles / App Notes
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
On February 9, 2012, almost two years after the Biologics Price Competition and Innovation Act was passed, FDA released draft guidelines concerning the regulatory path for biosimilars. Amy Ritter, S…
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Bracing for a Future Wave of Advanced Therapies
The Center for Medicare and Medicaid Innovation’s (CMMI’s) access model, the CMMI Cell and Gene Therapy Access Model, adopted in February 2023 (11), for example, is intended to establish a voluntary p…
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Evolving demands of process development services
Shifting demands from industry innovators is leading to an increased need for flexible and agile outsourcing partners offering broad and integrated models.
Over the years and in light o…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
An important innovation was FDA’s expanded use of the Emergency Use Authorization (EUA) process to speed successful products to patients during the health emergency. At the same time, the regulators r…
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Good Manufacturing Practices: Challenges with Compliance
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The complexity of biologics and the use of new technologies present challenges for complying with CGMPs.
By Lauren Lavelle
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Biomanufacturing: Demand for Continuous Bioprocessing Increasing
Biomanufacturing: Demand for Continuous Bioprocessing Increasing
But are innovations sufficient to increase adoption? CMOs are demanding better continuous bioprocessing options. …
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Gene Therapies Push Viral Vector Production
Other innovations, such as affinity ligands for specific AAV serotypes are being developed for use with these technologies to further enhance the resolution of the capture step. A major challenge rema…
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Improving Upstream Predictability
“Significantly higher cell densities will result in challenges with respect to mixing and oxygen transfer, while new modalities such as cell and gene therapies will require innovation,” he says.
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Moving PAT from Concept to Reality
…rmance, according to Arpan Mukherjee, technical committee coordinator for the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL). Raw-material characterization is performe…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
These recent innovations are better positioning exoglycosidases for routine use in analytical workflows that affect biologic drug analysis.
New problems, new solutions
An ongoing pharmaceutica…