July/August 2010 Issue
How Lonza Biologics applied Lean to speed and improve materials processing in Hopkinton, Mass.
New methods add speed and accuracy to the traditional challenge of counting particles in various pharmaceutical applications.
In text, illustrations, and video, Bren Kindelsperger makes the case for continuous wet mass granulation as an alternative to traditional methods of tablet and pill formulation.
Biotech Production: Planning, Scheduling and Throughput Analysis with a Combined Theory of Constraints, Lean and Simulation Approach
A major biotech company's only final stage bio-manufacturing facility in the world was struggling to meet rapidly increasing customer demand. Unanticipated production delays and frequent starvations at critical parts of the operation were causing not only late and missed deliveries, but also the expiration of product batches at a cost of approximately $1 million per batch.
Forget, for the moment, about process understanding and control. How are you doing on basic document retrieval?
Lean Six Sigma, expertise in microbiology, and shop-floor experience all contribute to running a flexible, efficient contract facility, says DPTs new director of sterile ops.
Big manufacturers have forgotten why they grew big in the first place, to the severe detriment of their PAT and QbD programs, says Contributing Editor Emil Ciurczak.
Is your family vacation a blackberry-free zone?
So much is to be gained, yet it is hard to tell whether any drug manufacturer has truly made progress over the last decade.
We have little grasp of the downstream impact of API's being discharged from our facilities.
Rapid microbiological methods can also be used for air and surface monitoring, with modest regulatory resistance.
Guidelines for pharma grade water have varied and often been a moving target. Pfizer's Cameron Sipe explains the importance of ISPE's new guidelines.