Search results for " report"
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Furthermore, the GC apparatus on the front end of the mass spectrometer can identify each of the different linked structures with their different reporter groups, because these have different elution …
Article
Selecting a Comprehensive Bioburden Reduction Plan
Mittelman and Anicetti are co-chairs of the Parenteral Drug Association task force that developed the bioburden and biofilm technical report titled, PDA Technical Report No. 69, (TR 69) Bioburden and …
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Cleaning of Dedicated Equipment: Why Validation is Needed
Even if some literature data report proposed visual limits, this test does not meet ICH Q7 expectations, as it may depend on too many variables that are difficult to standardize (5) and validate. Afte…
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The Bullish Outlook for Biosimilars
IMS analyzed the uptake of biosimilars across the EU and reported significant variation between countries as well as biosimilar classes (see Figure 1) (12). Such variation likely reflects local pricin…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
A recent reported example showed that the oxidized form of the organophosphite secondary antioxidant tris(2,4-di-tert-butylphenyl)phosphite (TBPP, often referred to under the trade name Irgafos 168) u…
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What Drove Biopharma Development in 2014?
According to a 2014 CPhI report, more than 70 percent of pharma manufacturers are looking to increase quality and invest in technologies and techniques like QbD to achieve that goal. And while QbD may…
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Viral Clearance Challenges in Bioprocessing
The Parenteral Drug Association Technical Report 47 (2) provides a framework for the preparation and characterization of virus preparations, and individual testing labs have developed their own descri…
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Setting Standards for Biotech Therapeutics in India
In this 31st article in the “Elements of Biopharmaceutical Production” series, the authors report on the evolution and future of IPC. The focus of the article is on biotech therapeutics.
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Relationship Building at Top of Mind for Clients
As results from BioPlan Associates’ 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production (1) show, however, it’s no longer enough for CMOs to lay claim to technolog…
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Single-Domain Antibodies for Brain Targeting
Transport across the BBB in human brain endothelial cells has been reported for llama sdAbs (39, 40). Using a llama sdAb phage display library (41), a new antigen-ligand system was identified for tran…