Search results for " report"
Article
What’s In a Name? For Biosimilars, A Lot
It has been reported that FDA determined that the United States Pharmacopeial Convention’s (USP’s) monograph for filgrastim does not apply to the first-ever approved biosimilar product, Zarxio (filgra…
Article
A Bright Future for the Plasma Fractionation Industry
Improvements in more established process operations, such as filter press operation and chromatography processes, were also reported.
Among the quality and regulatory trends, Quality-by-Design (…
Article
Use of Multivariate Data Analysis in Bioprocessing
The authors reported the application of PCA identified causes for batch deviations and revealed process differences between the 2-L and 10-L batches that were previously considered comparable.
For…
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…
Article
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…
Article
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…
Article
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…
Article
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 …