Search results for " report" in Articles / App Notes
Article
Re-use of Protein A Resin: Fouling and Economics
For other resins, the respondents have reported a decrease in DBC with a sharpening of slope of the breakthrough curve as the cycle number increases. Along with a decrease in resin binding capacity, r…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
Each of these methods measures different characteristics, but all three will report particle size and count. MFI differs from LO and CC by also providing particle shape and image intensity, for partic…
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Labeling of Biosimilars
EMA is under pressure to exert even tighter standards on biosimilars being marketed in Europe.
Feb 01, 2015
By Sean Milmo
BioPharm International
The European Medicines Agency (EMA) has r…
Article
Trends in Single-use Bioreactors
Sherman (Sartorius): In the past two years, the biopharmaceutical industry has reported inconsistent cell growth in bioreactor bags. Recent studies have shown that this can be attributed to a degradat…
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Healthcare Reform in China
A McKinsey report states that healthcare spending is expected to nearly triple from $357 million in 2011 to $1 trillion by 2020 (2). The Economist Intelligence Unit (EIU) projects that China’s populat…
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Applying GMPs to the BioPharma Supply Chain
Suppliers need to understand and apply the concept of corrective action preventive action (CAPA), and they need to be able to produce information and reports to support the paperwork trail.
Scient…
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FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
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Q&A with Eric Langer, about the evolution of the role of CMO’s in Bioprocessing
Can you tell us why that is?
Eric: Based on our 11th Annual Report, this focus on productivity is changing the way companies outsource, For example, there’s been a real push for more efficiency …
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Global Expansion Shapes Drug Oversight
Christopher Hickey, the director of FDA’s China office, reported on increased FDA inspections in China—up to 84 in 2013 from 46 in 2010. Hickey acknowledged that his office has only two full-time fiel…
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Quality by Design—Bridging the Gap between Concept and Implementation
EMA has reported that after averaging approximately five submissions per year since 2008, QbD applications went up to eight submissions last year. The rise in QbD applications from a low base could be…