Newsletter | December 5, 2019

12.05.19 -- EMA Shares Biosimilar Bright Spots, Challenges

Featured Editorial
EMA Update: What Challenges Are Biosimilars Bringing To The Table?
By Anna Rose Welch, editor, Biosimilar Development

One EMA regulator brought up several points at a recent conference that stood out, either as bright spots to boost industry morale or that emphasized where the industry needs to focus its energy to pave the way for future regulatory reform.

Are Good Manufacturing Practices No Longer Good Enough?
By Mark F. Witcher, Ph.D.

Janet Woodcock’s recent comment on the state of pharmaceutical development, “It’s not working …,” should not surprise anyone. Her continuation, “… and, it won’t work in the future," is the more surprising, and particularly troubling, statement. What must we change?

Industry Insights
An End-To-End, Semicontinuous Process For mAb Production
Application Note | GE Healthcare Life Sciences

See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semicontinuous process.

Stop Compromising Between High Yield And High Purity In Downstream Purifications
Application Note | Bio-Rad Laboratories, Inc.

Mixed-mode resins are often used when unimodal resins fall short of providing the required process productivity and/or process economics. To overcome this deficiency, Bio-Rad developed the Nuvia aPrime 4A Resin with an optimal balance of ion exchange and hydrophobic interactions to deliver simultaneous purity and yield of therapeutic proteins and monoclonal antibodies that are typically difficult to purify.

Don’t Let Insufficient Data Undermine Your CMO And CRO Selection Processes
Article | By Kevin Olson, ISR Reports

Selecting a partner is challenging, but with the right information you can simplify your efforts and increase your likelihood of making the best decision. 


CBI’s Specialty Therapies and Biosimilars Congress tackles challenges involved in managing the cost and quality of therapies that are controlling or conquering diseases that were once untreatable. Pharmaceutical executives, payers, PBMs (pharmacy benefit managers), and specialty pharmacies gather for an exchange of ideas on the latest challenges and trends. The conference includes a full track on biosimilars in addition to one on specialty therapies. You choose from sessions in both tracks.

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