Search results for " EMA" in Articles / App Notes
Article
Vaccine Development and Production Challenges Manufacturers
In 2014, GSK filed for approval of its RTS,S vaccine by the European Medicines Agency (EMA) under an EMA assessment process that could support a recommendation by the World Health Organization for mar…
Article
Challenges and Trends in Biopharma Facility Design
Quality control and building standards are also essential, with a view to meeting [European Medicines Agency] EMA, FDA, [Chinese Food and Drug Administration] CFDA, and other regulatory standards for …
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
The EMA mAb guideline also draws attention to a number of structural features including N- and C-termini (in particular pyroglutamic acid at the N-terminus and lysine at the C-terminus of the heavy ch…
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Top Process Development Trends for 2022 and a Look into 2023
FDA approved 37 drugs in 2022, within the normal range for the past decade or so. The European Medicines Agency (EMA) was even more successful—approving a record 55 therapies. More than half of thes…
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Developing a Robust Bioprocess Using Mechanistic Models
The safety and efficacy of a biopharmaceutical drug are of the highest priority. Therefore, manufacturers have to design, implement and maintain measures to ensure that the bioprocess con…
Article
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
Article
Leveraging Data for Better Biopharmaceutical Process Control
Leveraging Data for Better Biopharmaceutical Process Control
The need to improve and understand processes is moving PAT and more advanced control strategies beyond the lab into manufacturing and dow…
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Ensuring the Biological Integrity of Raw Materials
UV disinfection has some support from the EMA, which recommends it as one of two complementary virus reduction steps.
According to Sasges, combining inline UV disinfection with other barrier metho…
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Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
Article
Make buffer preparation more time and cost efficient with inline conditioning
Simplify Buffer Preparation
The volume and number of buffers for a typical downstream process can be considerable.
Preparation of these buffers is a challenge that in-line conditioning can o…