Search results for " 2016"
Article
ADC Development Robust Despite Lackluster Performance
The drug is among Roche’s top-10 selling products, earning 2016 sales of CHF 831 million (US$844 million) (3).
Seattle Genetics’ product, Adcetris (brentuximab vedotin), was approved in 2011. I…
Article
Biosimilars: Making the Switch Comes with Challenges
This view was echoed by speakers at the annual Biosimilar Medicines Group Conference in London on April 28-29 2016, organized by Medicines for Europe, previously the European Generic and Biosimilar Me…
Article
Preclinical Evaluation of Product Related Impurities and Variants
Narula, In Biomarker Discovery in the Developing World: Dissecting the Pipeline for Meeting the Challenges, 83-97 2016.
8. A. Beck, S. Sanglier-Cianférani, A. Van Dorsselaer, Anal. Chem., 84 (11…
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Unifying Continuous Biomanufacturing Operations
Lawrence Yu, PhD, deputy director in the Office of Pharmaceutical Quality at the Center for Drug Evaluation and Research (CDER), said in a 2016 FDA blog post that processes that take a month with fed-…
Article
Mechanistic Modeling of Preparative Ion-Exchange Chromatography
A 1437, 158–167 (March 11, 2016).
10. J. Winderl, Johannes, T. Hahn, and J. Hubbuch, J. Chromatogr. A 1475, 18–30 (Dec. 2, 2016).
11. B.K. Nfor et al., Biotechnol. Bioeng. 109 (12), 30…
Article
Pharma Investments Reflect Key Industry Trends
The company expects to create 300 jobs by the time the facilities are operational in 2016.
AstraZeneca: AstraZeneca announced in late 2013 that it is expanding its presence in Macclesfield, UK. Th…
Article
Virus-like Particles as Therapeutic Moieties of the Future
Analytical and functional characterization of virus-like particles enables process reproducibility and product consistency.
By Ramesh Kumar, Manidipa Banerjee, Anurag S. Rathore
Virus-like…
Article
Biopharma Seeks Balance
According to a Biotechnology Innovation Organization report (1) overall investment trends for R&D-stage companies were up in 2017 compared with 2016, despite a drop in the number of acquisitions. Gile…
Article
Downstream Processing for Cell-Based Therapies
By Qasim A. Rafiq, Fernanda Masri
With increasing numbers of advanced therapies—including cell and gene therapies—entering early- and late-stage clinical development, significant focus has been …
Article
Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…