Search results for " market"
Article
Putting Viral Clearance Capabilities to the Test
“As new markets open up to the industry, greater visibility of requirements supporting biosimilars, validation of continuous processes, and global submissions would be beneficial.”
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Article
Applying GMPs in Stages of Development
Applying GMPs in Stages of Development
Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, …
Article
Navigating Data Integrity in the Modern Lab
…systems are aware of the relevance of each step involved in the process, says Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes. Hayward spoke with Pharmaceutical Technology about…
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3rd BioProcessing Asia Preview: Q&A with John Curling
The 3rd BioProcessing Asia conference will take place November 12-15, 2018 on Langkawi, Malaysia. This week, Bioprocess Development Forum talks with John Curling, Conference Chair, about the upcomin…
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Roadmap Leads to Innovative Biomanufacturing Strategies
The cost of supplying a drug to market is appreciable, and the gain from collaboration in the pre-competitive space is likely to outweigh the apparent competitive advantage of keeping certain practice…
Article
Multidimensional Scale-Up of a Monoclonal Antibody Capture Step, Using ÄKTA™ pilot 600
Fast and efficient process development and scale-up contributes to a shortened time to market. In this work, a multidimensional scale-up (change of both column diameter and bed height) of a mAb capt…
Article
Bioburden Control in the Biopharmaceutical Industry
Microbiological Testing Has its Limitations
Reliance on only quality control tests to judge the safe release of the final product to the market may be misleading because of the nature of the…
Article
N-Glycan Analysis of Biotherapeutic Proteins
Of these, mAbs represent a large proportion of biotherapeutic glycoproteins and account for approximately half of the biopharmaceutical market, a trend that is set to continue with the advent of biosi…
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Managing Residual Impurities During Downstream Processing
“Laboratory service providers play a critical role in ensuring that their clients, specifically the pharmaceutical industry, only release product to the market place that are safe and efficacious, whi…
Article
Being Thorough When Transferring Technology
If this is not confirmed, then supplemental process characterization studies, in addition to the process performance qualification (PPQ) runs, can be proposed for the supplemental market authorization…