The company was developing a modified virus to be used in treatment to destroy cancerous tumours. To do this they needed equipment that could finely disintegrate and disperse the materials needed to produce the virus.
The milling of the materials is the step which releases the virus, after which it can be extracted and then genetically modified to target and destroy cancerous tumours.
The company contacted Silverson to test a lab mixer at the first stage of process development. The results they achieved using a Square Hole High Shear Screen were very good. In order to make the process safer, the company wanted to try a Sealed Unit lab mixer. They purchased a Sealed Unit lab mixer with assemblies that they could sterilise by autoclaving.
After using the sealed units for further trials, they wanted to be able to control the amount of shear imparted to the product during operation to get the precise results they were looking for. They decided to buy a laboratory scale In-Line assembly as this provides intense yet targeted high shear to the small amount of material in the mixing chamber; In-Line mixers can also be used for discreet passes between two vessels, giving the ultimate in control as they product can be processed by a defined amount.
They purchased several L5Ms with In-Line assemblies for use on 2-5 litre batches. After each use the In-Line assemblies were sterilised in an autoclave as they had done with their previous sealed units.
As the development process advanced successfully, the company needed to be able to work on a larger scale, but wanted to keep their procedure the same as it had been during the initial development stage using the lab mixers.
Silverson recommended a UHS with autoclavable design. At 5,000 rpm the UHS produces the same shear rate as that of the In-Line assembly at 8,000 rpm. This ensured the mixer produced the same results as the lab mixers and as a result, the process is now in industrial scale production, using two UHS In-Lines with the autoclavable design. The mixers are used on 20 litre single use process bags.
This highlights the advantages both of scalability within Silverson's product range and our ability to design and manufacture custom built, highly specialised equipment - two things most of our competitors cannot offer. As a result, the company were able to scale up successfully from lab trials without intermediate testing, a considerable saving in the pharmaceutical industry.
