Manufacturing
Advanced Emulsification Technologies
Narrow drop size distributions in the nanometer region
Typical devices for emulsification in industrial practice are for instance simple agitating rotorstator homogenizing or high pressure homogenizing Following is an overview on two stateofthe art emulsification technologies combined with handson experience from pharmaceutical and cosmetic applications Among others the examples will comprise a nove...
Manufacturing Control Systems
Inspired by the goals of optimising performance and providing paperless recordkeeping Process Control Systems PCS and Manufacturing Execution Systems MES have improved manufacturing operations for many pharmaceutical and biotech companies worldwide Fuelled by the adoption of industry standards and advances in technology these two systems are provid...
Lean Transformation
Superficial imitation or a paradigm shift?
For years The Shingo Prize has educated assessed and recognised operational excellence in outstanding companies What makes these organisations stand out and challenge their paradigm What tools and techniques are they usingwhat is their silver bullet Shigeo Shingo a management consultant and a practicing engineer grasped that true innovation and...
Ready-To-Use Technologies
Driving process excellence and product safety
B iopharmaceuticals have enjoyed good success since the introduction of the first genetically engineered insulin by Eli Lilly in and we have seen hormones vaccines interferons and the recent triumphs of humanised monoclonal antibodies Mabs adding to a long list of commercialisations As traditional pharmaceutical companies continue their struggle t...
PAT and ROI
A holistic approach
By offering companies a chance to understand and control their processes both at the RD and manufacturing stages PAT enables continuous quality verification and with it a chance to deliver consistent quality lower costs speed up product development and release improve market responsiveness and reduce supply chain bottlenecks Companies will also be...
Pharmaceutical Manufacturing
Embracing process analytical technology
Outside Life Sciences one would not hear much about Process Analytical Technology PAT a system for designing analysing and controlling manufacturing through timely measurements of critical quality and performance attributes of raw and inprocess materials and processes The idea behind PAT is not new It is more than a year old concept and a proven t...
Buying into Lean Pharma
Leadership My teeth were chattering against one another with my uncontrolled shivering I was physically exhausted mentally drained after three days of continual marching thinking and worrying about walking off the edge of the mountain Everything was damp It had been raining all night and we hadnt been able to make a dry camp We had just heard the...
Single-use / Disposable Technology
Considerations for Biopharmaceutical Facility Design
The biopharmaceutical industry is rapidly adopting singleuse disposable technology SU DT for clinical product launch and commercial production facilities to provide costeffective and flexible process capabilities Langer and Ranck These recent technologies have requirements advantages and disadvantages that differ from Traditional Reusable Techno...
Biopharmaceutical Operations
Developing the science
Thirty years ago the semiconductor industry was a growing technologyfocussed industry and for the first time was beginning to face cost pressures For years the focus had been on superior technology and manufacturing was an afterthought As long as the products were manufactured as they were envisioned by their inventors there was little need to pay...
Plant Automation in Pharma
An Asian perspective
The global production value of the pharmaceutical industry is expected to grow from US billion in to about US billion by The pharmaceutical industry is in rapid transition from a supplydriven market to a demand and servicedriven market where manufacturing efficiency and responsiveness will play a critical role in future success Manufacturing...
