Search results for " 2015"
Article
Aseptic Processing: Keeping it Safe
Although states currently oversee the activities of compounding pharmacies, FDA released new draft guidance documents in February 2015 seeking to exert more regulatory control over drugs produced by s…
Article
USP Stresses Pharmacopeial Standards at CPhI China
Jun 29, 2015
By BioPharm International Editors
The United States Pharmacopeial Convention (USP) hosted a pharmacopeial and regulatory compliance seminar at the 2015 CPhI China conference, he…
Article
A Bright Future for the Plasma Fractionation Industry
The 9th PPB meeting in May 2015 was no exception –140 participants from 25 different countries and representing 50 different companies or institutes – were treated to a full program with six scientifi…
Article
Advanced Technologies Facilitate Scale-up and Technology Transfer
Jun 01, 2015
By Cynthia A. Challener
BioPharm International
Volume 28, Issue 6, pg 20-23
It is hard to believe, but the biopharmaceutical industry is already old enough to have aging…
Article
Ensuring the Quality of Biologicals
This informational chapter, which is intended to be published by the end of 2015, has undergone public enquiry and gives examples of the critical quality attributes specific to each class of raw mater…
Article
Detecting Protein Aggregates and Evaluating their Immunogenicity
(2012), accessed January 2015.
2. M. Hasija, L. Li, and N. Rahman et al., Vaccine: Development and Therapy 3 1133 (2013).
3. R. Manning et al., “Review of Orthogonal Methods to SEC for Quantit…
Article
The Bullish Outlook for Biosimilars
16, 2015.
9. Generics and Biosimilars Initiative, “FDA receives application for monoclonal antibody biosimilar” (Aug. 28, 2014), www.gabionline.net/Biosimilars/News/FDA-receives-application-for-mo…
Article
Moving Biosimilars Forward in a Hesitant Market
Still, Gabrielson notes that the US lags roughly 10 years behind Europe in marketing biosimilars, with the first biosimilar, Zarxio (filgrastim-sndz), approved in the US in 2015 (1). “We’re looking at…
Article
Digitalization: The Route to Biopharma 4.0
In 2015 12th International Conference on Fuzzy Systems and Knowledge Discovery (FSKD); Zhangjiajie: IEEE; 2016. DOI: 10.1109/FSKD.2015.7382284
2. Knevelman, C.; Davies, J.; Allen, L.; et al. Hig…
Article
Emerging Therapies Test Existing Bioanalytical Methods
A guidance for this assessment was released in 2015 by FDA (6).
Cell-therapy assays
Cell-therapy products have evolved from blood, bone marrow, and stem cells to more complex engineered autolo…