Search results for " characterization"

Article Essentials in Quality Risk Management
…target product profile (QTTP), through CQA generation to analytical method selection, unit operation characterization, specification and acceptance criteria limit generation, critical process paramet…

Article Milestones and Moderate Progress in 2012 Drug Approvals
First gene therapy and plant-based expression vector products approved in 2012. In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharm…

Article Reviewing the Importance of Biosimilarity and Interchangeability
According to Stamm, biosimilarity studies generate extensive analytical data comparing the biosimilar product’s CQAs with the CQAs of the reference biologic, including physicochemical characterization

Article Unraveling the secrets of poloxamer 188 - A webinar mystery
When an inexplicable drop in cell culture performance is linked to a batch of media, researchers race to find the culprit. In this on demand recording we will unravel the mystery as we …

Article Bracing for a Future Wave of Advanced Therapies
With the help of recent investor interest, progression of advanced therapy medicinal products (ATMPs) in the clinical space continues to move forward. Buoyed by the regulatory approval of sever…

Article Paring Down Impurities in Downstream Processing
Myriad choices confront manufacturers before they even consider optimizing downstream processes. Each decision directly influences what final options will be available on arriving at the final…

Article Selecting Chromatography Resins for Bispecific Antibody Purification
Targeting enhancement with two active antibody arms makes bispecific antibodies (bsAbs) highly attractive for the treatment of cancer and other diseases. Their purification can be more challen…

Article Digitalization: The Route to Biopharma 4.0
Use of advanced data analytics is now extending to analysis of data from the large number of analytical and functional characterization assays that any manufacturer performs routinely. This has greatl…

Webcast Trace metals getting you down? Learn what’s really in your cell culture media with Cytiva.
So, how can you be sure these impurities are controlled? Trust the raw material characterization program at Cytiva. We designed it to give insight into the types and quantities of impurities present…

Article Trace metals getting you down? Learn what’s really in your cell culture media
Heavy metal might have a place in your music playlist, but heavy metals should stay out of your cell culture media. Heavy metal impurities in your media can have a drastic effect on cell vi…

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