Search results for " regulatory"
Article
mAbs to Watch in 2016
Sarilumab—This IL-6-receptor inhibitor from Sanofi and Regeneron—meant to treat rheumatoid arthritis—was originally projected by some sources to gain regulatory approval in 2015, but is now expected t…
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Quality Systems Key to Lifecycle Drug Management
FDA officials have long proposed that manufacturers implementing quality-by-design (QbD) approaches and quality controls should be able to manage postapproval changes with less regulatory oversight. T…
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Report from the 12th Plasma Product Biotechnology Forum
Despite the unusual raw material, there is a well-established and understood regulatory pathway through FDA-CBER. SAb Therapeutics has several projects in the pipeline, spanning from Phase 1 to Phase …
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Reimagining Affordable Biosimilars
Furthermore, adequate process controls to monitor and control product quality are necessary for receiving regulatory approval. Ultimately, this situation creates a burden on the manufacturer to invest…
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Good Manufacturing Practices: Challenges with Compliance
By Lauren Lavelle
BioPharm International spoke to Lauren Smith, senior director of quality, Catalent; Judy Cohen, vice-president of Quality and Regulatory at Lubrizol Life Science’s …
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Successfully Moving Regulated Data to the Cloud
If all of an organization’s data has been collected electronically, this can improve the process of reporting to assist with decision making and generation of submissions to the regulatory agencies.
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A Look into the Future of Biopharmaceutical Quality
…XEL and Susan Schniepp, executive vice-president of Post-Approval Pharma and distinguished fellow at Regulatory Compliance Associates (RCA).
Scientific Advancements vs. Regulations
BioPharm: …
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Roadmap Leads to Innovative Biomanufacturing Strategies
With a diverse pool of participants from industry, academia, and regulatory, the roadmap is the result of collaborative efforts.
BioPharm International interviewed three members of the steering …
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Labeling of Biosimilars
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has reached a key stage in the lengthy process of creating a regulatory framework for the development and…
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An Analytical Approach to Biosimilar Drug Development
The major regulatory authorities have issued guidance documents that clearly outline the expectations for developing a biosimilar. They emphasize that a step-wise approach should be taken to demonstra…