Search results for "regulatory" in Articles / App Notes
Article
Developing oligonucleotide therapeutics with confidence
In this video, we will look at key considerations for oligo therapeutic developers entering the market, such as scalability, flexibility, regulatory concerns, insource/outsource consideratio…
Article
Virus safety challenges: get the job done!
Virus safety is key in bioprocessing. In this free 1-day seminar you’ll learn how to conduct virus filterability trials, including prefiltration.
Click here for more information
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Cytiva seminar Milano: Accelerate biotech process development
Biopharmaceutical process development faces new challenges: shorter time-to-market and changing regulatory expectations for new molecular entities. Implementing tools and solutions are essential for o…
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Weighing the Benefits of Single-Use Consumables
… Support (at the time of interview); and Helene Pora, vice-president, Technical Communication & Regulatory Strategy, Pall, to get their perspective on the current benefits of single-use systems.
L…
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Cytiva Seminar Barcelona: Accelerate Biotech Process Development
Biopharmaceutical process development faces new challenges: shorter time-to-market and changing regulatory expectations for new molecular entities. Implementing tools and solutions are essential for o…
Article
Webinar: Establishing a CHO-K1 cell line and cell line development process for biotherapeutics markets
But how can you meet rapid timelines when the cell line development workflow is challenged by documentation needs, commercial use rights, and regulatory scrutiny?
Join Cytiva’s webinar on Febru…
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Advancing Global Collaboration for Drug Testing, Regulation, and Manufacturing
Regulatory authorities and biopharma companies are engaged in a range of collaborations to harmonize research methods, approval standards, and quality production methods key to expandi…
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Chromatography innovations for the diverse antibody pipeline
…variants need new ligands, new base matrices, or new chromatography systems, or they have different regulatory requirements, or application needs.
In this video Josefin Bolik, global product mana…
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Developing a Robust Bioprocess Using Mechanistic Models
Regulatory agencies such as the Food and Drug Administration (FDA) and European Medicines Agency (EMA) demand strict requirements on process characterization and validation studies and ask for a deep …
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e-Learning: what is quality by design (QbD)?
This free interactive course shares what quality by design (QbD) is all about. The focus lies on applying QbD to process development of biopharmaceuticals.
Key learnings:
- Fundamen…