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
Sean Moloughney, Nutraceuticals World||March 9, 2016 Ensuring nutraceuticals are produced safely and according to strict quality requirements is paramount in the current climate of regulatory scrutiny.
Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager, AIT Bioscience||January 28, 2016 The success of bioanalytical studies relies on the selection of the most suitable analytical method but the timeline of method development and types of analyses involved vary greatly.
Franklin Spriggs, Stephanie Mowery and Bo Kowalcyk, AIT Bioscience ||October 7, 2015 ADCs are a breakthrough cancer treatment that can deliver cytotoxins directly to cancer cells without the sweeping collateral damage of traditional chemotherapy.
Walt Berghahn , Healthcare Compliance Packaging Council (HCPC)||June 2, 2015 Spurred by several trends including the patent cliff, new product launches and changes in healthcare, the contract packaging market is looking at sustained growth in the years ahead
Patricia Hurley, Joan Boren and Costantino Congiatu, PPD||June 2, 2015 More than $60 billion worth of patents on biological products are expiring before 2020, representing a major opportunity for the pharmaceutical industry.
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