Search results for " biologics"
Article
Ensuring the Biological Integrity of Raw Materials
(2,3)
Global regulations, including those from the United States Department of Agriculture, the European Medicines Agency, and the FDA’s Center for Biologics Evaluation and Research (CBER) set sta…
Article
A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Process Development Forum speaks with Günter Jagschies, Cytiva, who is sitting on the organizing committee for the Recovery of Biological Products XVII Conference, which will take place June 19-24, …
Webcast
Webinar: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics
About this talk
Full title: Building an Innovative Integrated Continuous Downstream Manufacturing Platform for the Production of Biologics Presented by Irina Ramos, Director, Bioprocess Technology and…
Article
Meeting the Process Development Challenges of a Diverse Biologic Pipeline
While these novel biologics are filling drug pipelines, they are also challenging existing manufacturing processes in upstream, downstream, and analytical development.
Webcast
Recovery of Biological Products Conference
RECOVERY OF BIOLOGICAL PRODUCTS XX
We hope you are eager to participate in RXX and are pleased to announce the location and date of RXX!
We will convene June 2-7, 2024 at Sunriver Lodge in Sun…
Article
Current Trends in Host Cell Protein Detection for Biologics Manufacturing
Commonly accepted HCP analytical methods, the challenges of HCP assay, and recommendations on what can easily be accomplished in-house and when it may be better to outsource.
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Article
Developing a New Biologic Drug: Regulatory Challenges and Considerations
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Key milestones and planning ahead for compliance when bringing a new biologic drug to market
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
Article
Meeting the Process Development Challenges of a Diverse Biologic Pipeline
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Understanding the challenges novel and diverse biological molecules can create and how to manage these challenges is key to ensuring they reach patients safely and eff…
Webcast
Recovery of Biological Products XIX
The agenda will include progress on the state-of-the-art technologies and emerging trends in downstream unit operations for diverse biotherapeutic modalities (e.g. proteins, peptides, cell and gene …