Search results for " pharmaceutical" in Articles / App Notes
Article
The Bullish Outlook for Biosimilars
The cost of drugs has become a focal point of popular and industry dissatisfaction in the US, in spite of the relatively modest percentage of overall healthcare costs accounted for by pharmaceuticals …
Article
Fermentation for the Future
…uct can likely be purified more rapidly at lower cost and with the greatest chance for obtaining the pharmaceutical substance with its native conformation. “From a process perspective, soluble expres…
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Stock, American Pharmaceutical Review (Oct. 1, 2010).
2. T. Kingsbury, BioProcess Int. 12 (4) 18-21 (2014).
3. H.F. Giles, E.M. Mount, and J.R. Wagner, The Definitive Processing Guide and Hand…
Article
Ligand-Binding Assays and the Determination of Biosimilarity
In October 2014, the American Association of Pharmaceutical Scientists (AAPS) Ligand-Binding Assay Bioanalytical Focus Group Biosimilars Action Program Committee published a whitepaper with recommenda…
Article
What Drove Biopharma Development in 2014?
As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that trend is only expected to rise. According…
Article
Mechanistic Modeling: Does it Have a Future in Process Development?
The application of mechanistic models for process development and optimization has been a topic of discussion in the pharmaceutical industry for many years. Mechanistic models are considered as an a…
Article
Viral Clearance Challenges in Bioprocessing
…pply all of the measurements that are important for a production site that manufactures and releases pharmaceuticals for human use,” he asserts.
Importance of communication
Meeting regulatory r…
Article
Continued Process Verification for Biopharma Manufacturing
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About the Authors
Jeff Fleming is an independent writer with over 30 years of experience in pharmaceutical manufacturing.
Robin Payne is facilitator at the BioPhorum Operations Group,…
Article
Evaluating Design Margin, Edge of Failure and Process
ICH, Q8 (R2) Pharmaceutical Development (2009).
2. ICH, Q9 Quality Risk Management (2006).
3. ISO, ISO 9000:Quality Management (2005)
4. ICH, Q6B Specifications: Test Procedures and Accept…
Article
Single-Domain Antibodies for Brain Targeting
Single-domain antibodies are emerging as credible alternatives due to their target specificity, high affinity, and cost-effective recombinant production.
Smaller recombinant antibody fragments a…