Search results for "2014"
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
(DHI Publishing, PDA Books, 2014).
17. M. Gietl, B. Meadows, and P. Lopolito, “Cleaning Agent Residue Detection with UHPLC [7]” Pharm. Manufacturing (April, 2013), accessed Oct. 10, 2017.
…
Article
Development of Purification for Challenging Fc-Fusion Proteins
Sci and Tech 68(1) 30-37 (2014).
Author Biography
Ijeoma Cynthia Ikechukwu and Guodong Chen are senior scientists; Richard Ding is principal scientist; Evan Shave is associate director…
Article
Patenting Prospects for Cell-Based Therapies
5, 2014).
2. T.R. Heathman et al., Regen. Med. 10 (1), 49-64 (2015).
3. M. Sadelain, et al., “Nucleic acids encoding chimeric T cell receptors,” US Patent 7,446,190, Nov. 2008.
4. June The…
Article
Impact of Media Components on CQAs of Monoclonal Antibodies
30: 1419-31 (2014).
14. Dawn Sow Zong Leong et al., “Evaluation and use of disaccharides as energy source in protein-free mammalian cell cultures” SCIENTIFIC REPORTS (2017) DOI: 10.1038/srep45216 …
Article
Unifying Continuous Biomanufacturing Operations
The success of a truly integrated continuous processing platform relies on the collaborative efforts of upstream and downstream specialists.
By Randi Hernandez
When human cells travel throug…
Article
Critical Quality Attributes Challenge Biologics Development
Weiskopf, BioPharm International 27 (7) (July 2014).
3. Yan et al., Anal Chem. 2016, 88, 2041-2050.
Article
Cost Considerations Drive Lean Technology in Biopharmaceutical Manufacturing
Levine, Mabs 7 (1), 9–14 (2014).
4. P. Declerck, M. Farouk-Rezk, and P.M. Rudd, Pharm. Res. 33, 261–268 (Sep. 17, 2015).
Article
The Tide Stays High
The valuations and levels of public offering activity in 2014 and 2015 were not sustainable, and the NBI has never gotten back close to the levels it reached in 2015. Nevertheless, fundraising by emer…
Article
Efforts Accelerate to Streamline Postapproval Change Process
ICH, Final Concept Paper Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (ICH, July 28, 2014),
2. FDA, Established Conditions: Reportable CMC Changes f…
Article
An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
20, 2014).
4. EMA, Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products (London, 5.3.2011).
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