Issue Archive

Follow-on Biologics: Friend or Foe?
Debate over the regulatory fate of biosimilars seesaws between strong differences of opinion; can the parties achieve a balance?

Drug Manufacturing and Ethical Dilemmas Take Center Stage in "Cocktail"
A play about Thai AIDS drug developer Krisana Kraisintu opens in Louisiana this month, the result of a two-year collaboration between protein researcher Vincent Licata and New York-based performance artist Ping Chong.

From the Editor: Get to Know Shingo
The “other” Toyota engineer focused on the little things, the details, that collectively waste $50 billion in the drug industry each year.

Therapeutic Dose: The Times They Are A-Changin'
Until and unless the academic community responds with 21st century curricula, we will have to work with the graduates we have, not the graduates we would like to have.

Analytics and Follow-On Biologics: So Close and Yet So Far
Commercially available methods can compare certain characteristics of generic and innovator biologics, but there is no “magic bullet” yet available that can prove true comparability

Determining the Manufacturability of Drug-Layered Tablets
Statistical methods can be used to explain and correlate assay variability and the capability of the drug-layering process, allowing process accuracy to be improved and controlled.

Trace and Track to Seal the Cracks
After years of testing, some manufacturers are applying new technologies to thwart drug counterfeiters and ensure a safe supply chain.

Shingo Achievement Report Criteria
The Shingo Prize model evaluates 11 critical operational qualities, grouped into the following categories:

Six Sigma Lessons from Capsugel
Cross-regional participation, careful selection of Black Belt candidates and projects and minimizing workflow disruption are critical to success.

Pharma Takes the Prize
Two Baxter facilities won the elusive Shingo Prize for manufacturing this year, one for the second time. Could your organization be next? June is the deadline.

Shigeo Shingo : Quiet Firebrand
Photographs of Shingo suggest a very mild-mannered professorial type. But that demeanor apparently could, and did, disappear in a flash when anyone misunderstood a key concept.

Materials Tracking: It's All in the Data
Drugmakers are using MES and ERP more effectively and harnessing the power of new data acquisition tools.