Search results for " EMA"
Article
Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012.
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
This necessitated modifications to the purification process, which eventually allowed demonstration of comparability to the innovator and approval by the EMA (51). The success of a biosimilar developm…
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Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…
Article
Genetic Vaccine Platforms Demonstrate Their Potential
In a pandemic, genetic vaccines offer several advantages over traditional approaches.
By Cynthia A. Challener
For a vaccine to be effective, the components of the disease o…
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Reimagining Affordable Biosimilars
Advances in preclinical development play a crucial role in reducing cost for developing biosimilars.
By Anurag S. Rathore, Narendra Chirmule, and Himanshu Malani
Drug development is …
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An Analytical Approach to Biosimilar Drug Development
The EMA does not address interchangeability nor substitution in its guidance documents, but rather leaves it to individual European Union member states to further deliberate.
Analytical Advan…
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Putting Viral Clearance Capabilities to the Test
Process understanding and careful assessment of risks are essential in developing viral clearance programs.
By Rita C. Peters
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Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Under EMA regulations,
in-vitro studies must show that the antibody binds to the target antigen, that it is binding to representative isoforms of the three Fc gamma receptors, and that its Fab and…
Article
Innovation vs. Capacity: How CMOs Compete
… on regional, national, or local markets with limited experience with major regulatory regimes (FDA, EMA, Japanese Pharmaceuticals and Medical Devices Agency [PMDA]) outside of their home region
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
Abstract
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