GSK Post Learning Journey
At GSK, we were first introduced to the company and its plant in Singapore. GSK as a pharmaceutical company specialises in 4 different therapeutic areas, namely respiratory, central nervous sytem, anti-infective and alimentary and metabolic, as well as producing vaccines and products in consumer healthcare.
The site in Jurong is a Primary Manufacturing site, which is a global supplier of the active ingredients of many pharmaceuticals, including that in GSK's leading respiratory products like the Advair diskus for asthma patients. The secondary manufacturing process where the excipients and the powder carriers are added, are usually done in plants in the US and the UK.
There also exists a R&D pilot plant constructed recently (in 2008) on the Jurong site, which helps the company design manufacturing processes to bring new drugs into commercial production, through new process development, scale-up and eventual process optimisation for large-scale manufacturing. We were next introduced to the consideration that go behind such processes.
In process development, physical quality, chemical quality, yield, as well as the conditions and reagents required for reaction must all be considered to determine if the process would be safe and economical for the company.
In scaling-up, the following factors must be considered:
1) Time scale: how long will the reaction take
2) Mixing: what forms of agitation to use
3) Temperature control: to prevent potential explosions
4) Visibility: unlike in the lab, the reaction may not be visible from outside -> How to monitor reaction
5) Safety: Will the reagents, the vessel used and the heat produced be safe for workers?
In process optimisation, we were given the example of size control in the powder used for the diskus inhalers, in which the following factors had to be considered:
1) Seed loading and the resultant seed size (high seed loading would result in a smaller size)
2) Environmental conditions (e.g. Temperature)
3) Reaction conditions (Ramp/Rate; Ageing/Length of time)
4) Solvents/Antisolvents to be used
We were next then taken on a tour of the chemical factory, where we shown the various machines and apparatus used in the actual reaction and the subsequent crystallisation, evaporation, vacuum drying, vacuum filtration, centrifugation needed to obtain the final product. One thing was that was evident throughout was the use of automation throughout (except in some processes, like the removal of "cracks" in filtration) as well as the need to constantly monitor and control reactant conditions, such as the stirrer speed, temperature, pressure (the last being especially important with gaseous reactants) to prevent an explosion. We next listened to a production on sustainability and what GSK is doing to make the company environmentally friendly (More under "Sustainability")
Overall, the visit was an extremely interesting as I learnt the various considerations that go into the scaling-up process from laboratory to factory. I was fascinated by the large scale of the equipment used and how the manufacturing process was done.
The site in Jurong is a Primary Manufacturing site, which is a global supplier of the active ingredients of many pharmaceuticals, including that in GSK's leading respiratory products like the Advair diskus for asthma patients. The secondary manufacturing process where the excipients and the powder carriers are added, are usually done in plants in the US and the UK.
There also exists a R&D pilot plant constructed recently (in 2008) on the Jurong site, which helps the company design manufacturing processes to bring new drugs into commercial production, through new process development, scale-up and eventual process optimisation for large-scale manufacturing. We were next introduced to the consideration that go behind such processes.
In process development, physical quality, chemical quality, yield, as well as the conditions and reagents required for reaction must all be considered to determine if the process would be safe and economical for the company.
In scaling-up, the following factors must be considered:
1) Time scale: how long will the reaction take
2) Mixing: what forms of agitation to use
3) Temperature control: to prevent potential explosions
4) Visibility: unlike in the lab, the reaction may not be visible from outside -> How to monitor reaction
5) Safety: Will the reagents, the vessel used and the heat produced be safe for workers?
In process optimisation, we were given the example of size control in the powder used for the diskus inhalers, in which the following factors had to be considered:
1) Seed loading and the resultant seed size (high seed loading would result in a smaller size)
2) Environmental conditions (e.g. Temperature)
3) Reaction conditions (Ramp/Rate; Ageing/Length of time)
4) Solvents/Antisolvents to be used
We were next then taken on a tour of the chemical factory, where we shown the various machines and apparatus used in the actual reaction and the subsequent crystallisation, evaporation, vacuum drying, vacuum filtration, centrifugation needed to obtain the final product. One thing was that was evident throughout was the use of automation throughout (except in some processes, like the removal of "cracks" in filtration) as well as the need to constantly monitor and control reactant conditions, such as the stirrer speed, temperature, pressure (the last being especially important with gaseous reactants) to prevent an explosion. We next listened to a production on sustainability and what GSK is doing to make the company environmentally friendly (More under "Sustainability")
Overall, the visit was an extremely interesting as I learnt the various considerations that go into the scaling-up process from laboratory to factory. I was fascinated by the large scale of the equipment used and how the manufacturing process was done.