Search results for "biopharm"
Article
An Analytical Approach to Biosimilar Drug Development
Poon, Int J Biopharm Sci. online, DOI: 10.31021/ ijbs.201811091, May 24, 2018.
2. S. Berger, “How Analytical Technologies Support the Development of Biosimilar Drugs,” blog.waters.com/how-analyti…
Article
Selecting a Comprehensive Bioburden Reduction Plan
Targeting Bioburden
BioPharm: What type of planning is necessary to target all aspects of bioburden reduction?
Mittelman and Anicetti (PDA task force): The most important consideration in biob…
Article
Re-use of Protein A Resin: Fouling and Economics
Bracewell
BioPharm International
Volume 3, Issue 28
In the past two decades, Protein A affinity chromatography has remained the de facto capture step for purification of monoclonal antibod…
Article
Impurity Testing of Biologic Drug Products
Method development and validation
BioPharm: What is the right approach to method development and validation for therapeutic proteins?
Kang (Patheon): Two concepts are key to appro…
Article
Modular Manufacturing Platforms for Biologics
…d 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 particl…
Article
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…
Article
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…