Search results for " efficacy" in Articles / App Notes
Article
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 …
Article
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…
Article
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…
Article
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…
Article
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…
Article
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, …
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Tackling Analytical Method Development for ADCs
…ocess knowledge support the idea that manufacturing and analysis of ADCs with consistent quality and efficacy is achievable, according to Kaur. He also notes that with the move to adopt a quality-by-…
Article
Fermentation for the Future
In yeast, N-glycosylation does not occur in the same manner as it does in humans, which can affect the efficacy of the therapeutic protein. Therefore, genetic engineering of P. pastoris was pursued to…