Search results for " Biopharm" in Articles / App Notes
Article
Selecting a Comprehensive Bioburden Reduction Plan
Process maps and risk assessments are among the valuable tools operators can apply to reduce the risk of microbial contamination.
By Randi Hernandez
There are multiple variables to consider …
Article
Re-use of Protein A Resin: Fouling and Economics
In this thirty-second article in the “Elements of Biopharmaceutical Production” series, the authors present the outcome of a survey that was recently performed jointly by researchers at Indian Institu…
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Impurity Testing of Biologic Drug Products
Experts share insights on the various methods used for purity and impurity analysis of therapeutic proteins.
By Adeline Siew, PhD
CA-SSIS/shutterstock.comIm…
Article
Modular Manufacturing Platforms for Biologics
…ed by applying methods described in Federal Standard 209 may affect operations of a cleanroom” for biopharmaceutical processes. Thus, the company writes, a measure of both viable and nonviable partic…
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Detecting Protein Aggregates and Evaluating their Immunogenicity
Particle-detection methods
There are various detection technologies that should be used to address protein aggregation needs at various phases of the biopharmaceutical development process; however…
Article
Tackling Analytical Method Development for ADCs
“Cross-fertilization within the biopharmaceutical industry, particularly driven by the proliferation of ADC-focused conferences, workshops, instrument company webinars, etc., has lead to an increased …
Article
Trends in BioPharma Approvals in 2013
A total of 16 approvals were recorded in Europe, while only six biopharmaceuticals came on the market in the US in that same period. This trend can partly be explained by Europe playing catch up in th…
Article
Milestones and Moderate Progress in 2012 Drug Approvals
Twelve biopharmaceutical marketing applications were approved in the United States and/or the European Union in 2012 (see Table I). Approval numbers for the past year are in line with those recorded o…
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Addressing the Challenges in Downstream Processing Today and Tomorrow
While there is agreement on the value of process and product understanding, there is often debate within most biopharmaceutical companies on the extent of QbD investment and underlying cost implicatio…
Article
Moving Biosimilars Forward in a Hesitant Market
On the pricing pressure aspect in the biopharma market, Gabrielson asserts that pricing pressure is a central theme in biosimilars. “That is why these products exist, fundamentally,” he remarks, “to m…