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The primary objective of any R&D project is to make a product commercially viable as quickly as possible. As a result, it is vital that researchers use the correct technologies and methods from the start of the process to ensure the product can be suitably scaled up to meet demand. For a new development to be of optimum success, it should be managed in such a way that the R&D phase and manufacturing phase follow the same conditions, needing little to no adjustments.
In today’s competitive market there is an increasing need for contract research organisations (CROs) and biotechnology companies to differentiate themselves. Consequently, the ability to scale up and future-proof a customer product could be the difference in becoming a market leader, especially if your business can offer the following USPs:
- Cost efficiency
- Time efficiency
- Regulatory adherence – cGMP
Biopharma Group’s range of high pressure homogenisers by Avestin, caters for a breadth of throughputs, ranging in flow rate from ml to 1000L per hour. Equipment follows a scalable design, offering end users confidence that, whatever their process requirement, a solution exists which in turn, reduces costs incurred in reworking already tried and tested R&D methods to suit both the pilot and production environments.
Another area to consider within your R&D processing and long-term project objectives is sample heating, especially when under pressures such as those used in high pressure homogenisation which can be used across a multitude of applications from emulsion creation to protein expression. Certain samples are more sensitive to heat generation than others of course. For example, in the case of DNA or protein isolation, it is crucial that the optimal homogenising pressure for a particular sample does not induce a temperature high enough to damage sensitive intracellular products. This becomes amplified and more apparent as batch volume increases from a few ml to litres. Figure 2 below shows the benefits of incorporating heat exchanger into your homogenisation process.
With the sample heat a consideration across the full range and scalability part of the design process, Avestin’s EmulsiFlex range allows users to perform both homogenisation and extrusion of liposomes in solution whether your unit is a benchtop R&D scale C5 or a production scale C1000. Each model facilitates controlled, consistent homogenising pressures, to narrow the distribution of liposome sizes once forced through the filters, allowing you to scale up liposome production easily to meet demand.
Avestin instruments combine homogenisation and extrusion in a continuous process, which greatly reduces the number of required passes, and allows for the desired particle size distribution throughout the sample. This is one of the reasons why extrusion has become a popular, time-efficient, and easily reproducible technology especially when considering unilamellar liposome formation with no detectable degradation of phospholipids.
Contact one of our specialists to discuss your requirements on how to effectively scale up your R&D process, request a GMP software demo or discover more about our high pressure homogenisers range today.
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