Thursday 13 April 2017

MTS Recommends... Covalidation Strategies

Covalidation Strategies to Accelerate Analytical Method Transfer for Breakthrough Therapies

Apr 02, 2017
By Kieran O’Connor, Nicola Hulme, Yueer Shi
Pharmaceutical Technology, Volume 41, Issue 4, pg 38–41, 44–48

"An important operation in the registration approval of a new drug product is the commercial-scale validation campaign at a receiving manufacturing site, which requires the technology transfer of analytical methodology from the transferring site. Traditionally, Bristol-Myers Squibb (BMS) used the comparative testing technology transfer model. In a recent launch of a product with breakthrough designation status, however, BMS used the covalidation technology transfer model, which involves simultaneous method validation and receiving site qualification. The authors describe the development and implementation of covalidation strategies to accelerate analytical method transfer using examples from a pilot study."

Monday 10 April 2017

Wednesday 5 April 2017

MTS Recommends... The Sound of Compliance

MTS Recommends... Evaluating Progress in Analytical Quality by Design

Evaluating Progress in Analytical Quality by Design

"The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts."
 Apr 02, 2017
By Mark Argentine, Kimber Barnett, Marion Chatfield, Elizabeth Hewitt, Patrick Jackson, Shreekant Karmarkar, Ariane Marolewski, Andrea M. Pless, Andy Rignall, David Semin, Mark D. Trone, Qinggang Wang, Zeena Williams, Yanqun Zhao
Volume 41, Issue 4, pg 52–59