Search results for " formulation"
Article
Breakthrough Drugs Raise Development and Production Challenges
For biologics, breakthrough designation may prompt greater focus on the reliability of the Phase I cell line, process and formulation, as shorter pivotal trials may truncate optimization of the Phase …
Article
Taking a “Development-by-Design” Approach to Cell Therapies
Have the end in mind
Such things as formulation issues, dosage potency, impurities, residuals, and microbial assurance need to be thought out clearly from the start, Hampson says, as well as indic…
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Biosimilars Will Bring Significant Litigation and Patent Challenges
Fuller adds that the immunogenicity risks associated with biosimilars could relate to their formulation and technology platforms, “but the specific patents will not be known, as the originator will no…
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…
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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…