Search results for "analytics"

Article Reliability Rooms and the Move to Proactive Supply Chain Management
Grounded in pure, fundamental data analytics, this concept is roughly translated as “gathering all the information that is required to make fast, sound decisions that enable robust and sustainable imp…

Article Modeling and Miniaturization: Key Topics at Successful HTPD Conference
If so, two areas that were highly requested are high-throughput analytics and data management/data mining. In conclusion, during the four days in October in Toledo, it was obvious that HTPD is sti…

Article Manufacturing Standards Key to Advancing Cellular and Gene Therapies
Manufacturing Standards Key to Advancing Cellular and Gene Therapies FDA works with industry on strategies for assuring high-quality regenerative medicines. By Jill Wechsler …

Article Continuous Processing for the Production of Biopharmaceuticals
The authors review the technologies that may help bioprocessing become a truly continuous operation and present case studies that could contribute to the integration of upstream and downstream platf…

Article Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
However, advances in high-throughput analytics, data processing, and medium and feed preparation are also warranted. About the Authors Colin Jaqu…

Article Cleaning of Dedicated Equipment: Why Validation is Needed
This article discusses cleaning validation of equipment dedicated to the production of a single API. By Cristina Baccarelli, Paola Bernard, Teresa Cortellino, Oscar Cruciani, Rita Pacello, Chi…

Article FDA Approves First Biosimilar
Mar 06, 2015 By Randi Hernandez BioPharm International FDA approved Sandoz’s Zarxio (filgrastim-sndz) on March 6, 2015. The approval is a groundbreaking decision, as Sandoz is the firs…

Article Setting Standards for Biotech Therapeutics in India
The authors take a look at the past and future impact of the Indian Pharmacopoeia Commission. By: Anurag S. Rathore, PhD, Renu Jain, M. Kalaivani, Gunjan Narula, G. N. Singh BioPharm Inter…

Article DoE Provides Benefits, but Preparation Is Necessary
Nov 1, 2014 By: Cynthia Challener, PhD BioPharm International Volume 11, Issue 27, pp. 28-29  Using a design-of-experiment (DoE) approach allows a formulation development scientist t…

Article Challenges of Protein Aggregation During Purification
Careful selection of downstream processing conditions is a must. Sep 1, 2014 By: Cynthia Challener, PhD BioPharm International Volume 27, Issue 9, pp. 32-35  Removal of protein a…

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