Search results for " formulation" in Articles / App Notes
Article
Modular Manufacturing Platforms for Biologics
The module should also have areas for product formulation; fill/finish; material dispensing, washing, sterilization of parts; and lyophilization.
A manufacturer has to consider location-specific c…
Article
Continuous Manufacturing: A Changing Processing Paradigm
…ous Manufacturing successfully churned out the first end-to-end, completely continuous synthesis and formulation of a treatment for high blood pressure in 2013, aliskiren hemifumarate (16). While thi…
Article
SEC in the Modern Downstream Purification Process
…ions can be tailored to suit the requirements of the sample being purified for further processing or formulation and storage without having an effect on the actual separation. This lack of chemical i…
Article
The Bullish Outlook for Biosimilars
Following traditional product-line extension approaches, many of these biobetters are sustained-release formulations of the existing drug, which can provide enhanced convenience and prolonged effect. …
Article
Quality by Design and Extractable and Leachable Testing
Consideration should be given to materials sourced, formulation, storage conditions, and sterilization techniques.
An example of using risk analysis to inform CQA is in the Product Quality Researc…
Article
Technologies and Practices Must Evolve to Meet Demand
…g including process development, drug-substance and finished product manufacturing, quality control, formulation, clinical-trial material manufacturing, and fill/finish.
More than 45% of the resp…
Article
Biopharma Manufacturers Respond to Ebola Crisis
Demand for new therapies and vaccines spotlights production challenges.
Oct 1, 2014
By: Jill Wechsler
BioPharm International
Volume 27, Issue 10, pp. 8-9
The development of new tr…
Article
Pharma Investments Reflect Key Industry Trends
In October 2013, however, Teva opened a $100 million plant in Croatia that produces tablets, capsules, and sterile formulations for the European and US markets.
About the Author
Cynthia Challe…
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
When SEC alone is suitable
In certain purification or formulation tasks, it may suffice to determine only the fraction of aggregated protein relative to the unaggregated monomer, rather than the t…
Article
Challenges in Analytical Method Development and Validation
While the method may go through various iterations during product development, as the final formulation emerges, the method will be optimized and ready for validation. The analytical method will becom…