Search results for " IND"
Article
Planning for IND
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Learn how to navigate regulatory requirements as you progress through clinical trials to commercialization.
Article
Getting your investigational drug regulatory ready
Navigating regulatory requirements can be an overwhelming and time-consuming part of the translational journey. From the submission of an investigational new drug (IND) application, regulators…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
…g applications (INDs) currently on file, and that by 2020, they expect to be receiving more than 200 INDs per year (1). Based on this forecast, the industry expects cell and gene therapy products to …
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Applying GMPs in Stages of Development
The process used in the industry to determine root cause is, of course, the investigation procedure. This procedure, regardless of whether the product you are investigating is biotech or traditional, …
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Report from the 6th International HTPD Conference
Professor Micheletti presented a historical view on the origin of microwell plates, and how the understanding of the flow and mixing in individual cells on the plate has evolved, along with case studi…
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Updating Viral Clearance for New Biologic Modalities
“The industry has a way to go in developing a range of viral clearance products that enable efficient separation of more complex mAbs, such as bispecific or Fc-fusion proteins,” he says.
Another c…
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Reimagining Affordable Biosimilars
Because the therapeutic dose and clinical indications are established by the reference product, Phase II trials are typically not required for biosimilars. A Phase III trial is a confirmatory study fo…
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Addressing the Complex Nature of Downstream Processing with QbD
The industry has been slowly adopting the QbD approach, but with the boom in the biopharma industry, how have these QbD principles fit into the complex nature of biologics? According to Gunnar Malmqui…
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Science Focus Fuels Successful Process Development for Startups
BriaCell Therapeutics (BriaCell) is an immuno-oncology company that develops novel targeted immunotherapies for multiple cancer indications. These immunotherapies include Bria-IMT and Bria-OTS, which …
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Leveraging Computational Models of Glycosylation for Biopharma QA
Glycosylation impacts the safety and efficacy of protein therapeutics
The following individual glycosylation motifs that are known to influence the safety, pharmacokinetics, and pharmacodynamics o…