Technical Development: Oral Dose Platforms
Pilot Scale
The Oral Dosage Development Facility in Genzyme, Waterford has been in operation since March 2003. This facility serves the following key roles for Genzyme:
 | Production of clinical trial materials from Phase II onwards in support of Genzyme R&D pipeline.
|
| Execution of registration batches in support of new product approvals.
|
| Process development capability as part of new oral dosage formulation development, including manufacturing and analytical capability.
|
| Provision of first class technical support capabilities to the full scale oral dosage manufacturing facilities in Waterford. This is achieved through use of equivalent process equipment to that utilised at full scale (1000kg) for the purposes of trouble shooting, scale up, process investigation, process optimisation.
|
| Training/development environment for new/existing employees. |
The novel and non routine nature of work to be carried out in the development facility demands that whenever possible, flexible facility design considerations have prevailed to allow for future new processes, products and ways of working.
The facility is capable of handling batch sizes up to 100kg (depending on product characteristics) for solid dose formulations. Process technologies include wetting/granulation, drying, milling, blending, compression and film coating, sachet powder blending and filling, encapsulation.
The facility is designed and operated in full compliance with safety and cGMP requirements appropriate to EU Grade D/Fed. Std. 209E Class 100,000.
Laboratory Scale
In September 2005, small scale equipment capable of handling batch sizes less than 10kg was installed. Process technologies feature wetting/granulation, milling, blending (including in line Near Infra Red) and compression. The laboratory scale facility is focussed on the Execution of experimental batches to assess formulation and process robustness of new oral dosage products.
Technical Development: Fill Finish Platforms
Technical support of Fill Finish Manufacturing operations includes;
| Leading technical development and introduction of new products and processes to Waterford Fill Finish
|
| Dealing with product related deviations / complaints / investigations
|
| Application of Quality by Design principles to existing and intended new products |
This work is supported from dedicated laboratories equipped to carry out a wide range of support activities such as;
| Filtration / filling trials
|
| Leachables and extractables
|
| Particulates
|
| Container closure
|
| Lyophiliser cake evaluation |
|
Genzyme Ireland Home
