Search results for " development"
Article
What Drove Biopharma Development in 2014?
As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that trend is only expected to rise. According…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
Novo Nordisk uses mechanistic models for the development of selected downstream process steps. Following his keynote presentation to attendees at the recent HTPD Conference in Italy, Arne Staby, PhD, …
Article
EMA Invites Comments on New Guidance for Vaccine Development
The guidance covers the non-clinical and clinical requirements for the development of new influenza vaccines and aims to facilitate the prompt assessment of new vaccines. It follows the publication of…
Article
Insights from process developers - top challenges in recombinant protein purification
This constantly evolving molecular diversity brings challenges in chromatography process development. In this article, we focus on the challenges in purifying recombinant proteins that lack affinity c…
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
Tools and methodologies for smarter downstream process development
…nal and answers the following questions:
What do we mean when we say “Smarter process development” in biopharma?
What are the key drivers for it this need to go smarter and faster…
Article
Trends in Outsourcing of Bioprocess Development
Many of the biopharma companies behind these drugs are seeking assistance with bioprocess development from outsourcing partners with platform solutions and specialized knowledge, expertise, and techno…
Multimedia
Using mechanistic modeling in process development for advanced therapeutics
Peter Guterstam and Nick Whitelock discuss mechanistic modeling in process developemnt of advanced therapeutics.
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Article
Pandemic Alters Policies and Practices for Drug Development and Regulation
Drug development and regulation will never be the same following the momentous changes in healthcare delivery and biomedical research over the past year. The desperate need for new vaccines and therap…