Search results for " pilot production"

Article Sanitization of ÄKTA™ pilot 600 Using Sodium Hydroxide
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this stu…

Article FDA and EMA Extend QbD Parallel-Assessment Pilot Program
FDA and the European Medicines Agency (EMA) have extended the joint pilot program for the parallel evaluation of quality-by-design (QbD) applications for two years beginning April 1, 2014. In the jo…

Article Regulatory Challenges in the QbD Paradigm
The authors demonstrate how an integrated model is helping to achieve regulatory flexibility. This article is part of a special section on biopharmaceutical trends. With the dawn of the 2…

Article Quality by design for biotechnology products—part 1
A PhRMA Working Group's advice on applying QbD to biotech. By Taruna Arora, Roger Greene, Jennifer Mercer, Paul Tsang, Meg Casais, Stuart Feldman, Jutta Look, Tony Lubiniecki, Joseph Mezzatesta,…

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 Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology. By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…

Article Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments. Aug 2, 2014 By: Cynthia Challener, PhD Pharmaceutical Technology Volume 37, Iss…

Article Being Thorough When Transferring Technology
Communication and taking the time to develop the process are key to successful transfer and scale up of biologics. By Susan Haigney Editor's note: The following is an extended version of the…

Article Lessons Learned Accelerate Vaccine Development
Collaboration and single-use technologies aided the rapid scale-up of Ebola vaccine manufacturing. By Cynthia A. Challener Vaccine development is a complicated process that can take many yea…

Article The Outlook for CMO Outsourcing in 2019
By Eric Langer and Ronald A. Rader Biopharmaceutical industry-related indicators and trends are supporting continued incremental increases in outsourcing of pre- and commercial AP…

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