July 31, 2015 Assurance of the vacuum integrity of freeze - dryers used for the manufacture of sterile pharmaceutical products is essential for GMP operations; however, there is currently no generally accepted scientific rationale for establishing acceptance crite…
Thorsten Sogding, Daniel Canton, Daniel Haines, Uwe Rothhaar, SCHOTT Pharma Services || June 2, 2015 As the demands that are being placed on the quality and stability of medications continue to increase, the interactions that take place between the primary packaging container and filled drug product are becoming increasingly important
Stephanie Mowery, Sherri Rinker, Franklin Spriggs and Bo Kowalcyk , AIT Bioscience || June 2, 2015 Moving forward clinical studies will have to include a comparative assessment of
pharmacokinetics and immunogenicity to the original reference biologic drug
Kristin Brooks, Contract Pharma || May 19, 2015 Niall Dinwoodie of Charles River discusses several key industry issues on biosimilars and addresses some of the development and regulatory hurdles that remain
May 8, 2015 The chemical structure of a customer’s new molecule indicated potential for oxidative degradation and hydrolysis. Through binary excipient compatibility testing, Patheon was able to focus efforts on a formulation with maximum stability.…
Tim Wright, Editor || May 6, 2015 Herein are the results of our 2015 Annual Outsourcing Survey, where we call on you, the readers, to help us benchmark the state of the pharmaceutical outsourcing industry.