Search results for "regulatory"
Webcast
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…
Article
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…
Webcast
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
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…
Article
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…
Webcast
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 February…
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…
Article
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…
Article
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…
Article
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 …