Search results for "FDA" in Articles / App Notes
Article
Getting Your Investigational Drug Regulatory Ready
READ FULL ARTICLE >>
Navigating regulatory requirements can be overwhelming. This article outlines basic strategies for efficient regulatory review and drug approval.
Article
Selecting Chromatography Formats for Your Process Development Workflow
The quality-by-design initiative by the FDA puts additional demands on process development work because a higher degree of process understanding is needed.
Therefore, the choice of tools is critic…
Article
Ajinomoto Bio-Pharma Services, CytoDyn in Manufacturing Partnership for COVID-19 Drug
It has been and is currently being administered to COVID-19 patients at New York City area hospitals as part of an emergency investigational new drug (EIND), granted by FDA as part of Phase I, Phase I…
Article
Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
Although the industry as a whole has been slow to adopt these techniques, FDA actively encourages continuous production, and companies such as Sanofi and WuXi Biologics have made significant investmen…
Article
2019’s Top Bioprocessing Trends and What to Expect in 2020
FDA approvals announced during the year for cell and gene therapies prompted the need to consider manufacturing facility designs specific to cell and gene therapy workflows, as well as the need to exp…
Article
Optimizing Drug Safety and Efficacy of Complex Next-Generation Biologics
FDA approved 17 biologics out of a total of 59 drugs—the highest number to date.
This article will delve into why the pharma industry is heading toward a biologics revolution, what challenge…
Article
Design Considerations for a Commercial Cell and Gene Therapy Facility
By Feliza Mirasol
With the recent FDA approvals and commercialization of cell and gene therapies in the US market and a pipeline of cell and gene therapies progressing toward regulatory review, …
Article
Science Focus Fuels Successful Process Development for Startups
… a stem-cell therapy that it took from preclinical development to two Phase II trials in Europe and FDA approval for an investigational new drug (IND). “What we learned while carrying out tech transf…
Article
Modeling the Degradation of mAb Therapeutics
FDA has approved a number of these antibody drug molecules, which are in various stages of clinical and pre-clinical development. But since the major constituent of the final drug product is protein, …
Article
The Outlook for CMO Outsourcing in 2019
FDA approved approximately 25 new biopharmaceuticals in 2018 (1), and the number of annual approvals is expected to increase in coming years, as new classes of products receive approvals, particularly…