Search results for " efficacy"
Article
Implications of Cell Culture Conditions on Protein Glycosylation
These structural variations can have a large effect on the drug’s efficacy and properties.
By chemically modifying the permethylated glycans and attaching particular “reporter groups” wherever each…
Article
Biopharma Advances Demand Specialized Expertise
Those companies that are best able to successfully characterize and differentiate innovator and biosimilar products for safety and efficacy will have the greatest opportunity to benefit.
The knowle…
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Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
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A Bright Future for the Plasma Fractionation Industry
The take-home message was that the efficacy of plasma manufacturing steps for inactivating/removing HEV provides good assurance regarding the safety of the final plasma protein product.
Another …
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Single-use and modular technologies plus continuous manufacturing are increasingly important to biopharma scale-up and tech transfer.
Jun 01, 2015
By Cynthia A. Challener
BioPharm Inte…
Article
Use of Multivariate Data Analysis in Bioprocessing
Further, any optimization efforts targeted to improve product yield or productivity need to be carefully monitored for any possible negative impact on a product’s safety and/or efficacy. To achieve th…
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Ensuring the Quality of Biologicals
…s are needed to generate evidence substantiating the similar nature, in terms of quality, safety and efficacy, of the similar biological medicinal product and the chosen reference medicinal product a…
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Re-use of Protein A Resin: Fouling and Economics
Monitoring of resin performance
It is well known that the efficacy of the chromatographic resin changes with use and as a result of it being stored for long periods of time (19). It has been obser…
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USP Publishes Monoclonal Antibody Guidelines
…ded in healthcare, raising questions and presenting crucial issues associated with their quality and efficacy. Unlike small-molecule medicines, which have more easily defined quality attributes and a…
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Vaccine Development and Production Challenges Manufacturers
The planned three-arm randomized, double-blinded trial began in early February 2015, and aims to enroll 27,000 healthy volunteers to support this effort to collect clear evidence of safety, efficacy, …