Search results for "2014" in Articles / App Notes
Article
Biomanufacturing Outsourcing Globalization Continues
Data from the 2015 survey shows expected levels of biomanufacturing operations offshoring that are steady with 2014, with a greater proportion of respondents (close to two-thirds) envisioning offshori…
Article
Virus-like Particles as Therapeutic Moieties of the Future
61 (2) 531–539 (2014).
P. Pushko, P. Pumpens, and E. Grens, Intervirology 56 (3) 141–165 (2013).
A. M. Wen and N. F. Steinmetz, Chem. Soc. Rev. 45 (15) 4074–4126 (2016).
P. Krambe…
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
In 2014, using next-generation sequencing (NGS), FDA’s Center for Biologics Evaluation and Research (CBER) retrovirus laboratory identified a novel rhabdovirus in Spodoptera frugiperda type 9 (Sf9) ce…
Article
GMP Challenges for Advanced Therapy Medicinal Products
In fact, these difficulties could be a prime reason why, up until 2014, only four medicines under the ATMP regulation had been given marketing authorization in the EU’s centralized medicines licensing…
Article
Drug Discovery and Development in India
Lupin Pharmaceuticals has set up two research and development plants in the United States while Cipla said in July 2014 that it will invest $150 million in the United Kingdom for research and clinical…
Article
Labeling of Biosimilars
In December 2014, guidelines on quality standards for biosimilars with proteins as an active substance came into effect (1), while guidance on clinical and non-clinical issues with the products was be…
Article
Setting Standards for Biotech Therapeutics in India
IP 2014 had 577 new monographs and included monographs of API [134], formulations [161], excipients [18], new drug substances [43], antiviral [11] and anticancer [19], antibiotics [10], herbal [31], v…
Article
Framing Biopharma Success in 2016
Breakthroughs, biosimilars, and bottlenecks
Many of the new molecular entities—41% of the approvals in 2014 and 47% of the approvals in 2015—were for rare diseases that target smaller patient popu…
Article
Host-Cell Protein Measurement and Control
2367-79, 2014.
6. ICH, Q6B, Specifications: Test Procedures And Acceptance Criteria For Biotechnological/Biological Products (ICH, March 10, 1999), www.ich.org/fileadmin/Public_Web_Site/ICH_Produc…
Article
Biopharma Manufacturers Respond to Ebola Crisis
Oct 1, 2014
By: Jill Wechsler
BioPharm International
Volume 27, Issue 10, pp. 8-9
The development of new treatments to combat the lethal Ebola virus has been slow, stymied by difficulti…