Search results for " regulatory" in Articles / App Notes
Article
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 …
Article
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 …
Article
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…
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What's in Your SOP?
SOPs need to reflect a company’s specific manufacturing or other operations, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
By S…
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Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…