The effectiveness of the technologytransfer process is critical to maintaining product quality and decreasing time-to-market. Using different systems from different vendors can impede transfer and force processes developed at one scale to be recreated and re-optimised at other scales; for example, a vendor may not be able to offer its solution at all scales from process development to manufacturing, in which case the client would be forced to buy products and technologies from multiple vendors that may not be fully compatible with one another. Differences in product claims and shelf life from multiple vendors can also impact the implementation of single-use technology during technology transfer.

Using replicable, modular single-use systems, however, can facilitate cost-effective and timely technology transfer across multiple sites and different scales because the same product technology platform, same contact materials and product claims make the qualification process easier.

Impact on the bottom line

Optimising tangential flow filtration

Tangential flow filtration (TFF) can rapidly and effectively separate and purify biomolecules. Employing single-use systems in this area can improve product yield, quality and purity. The first step in TFF process development is to define what the process must achieve and what goals must be met. Understanding these objectives will aid selection of the appropriate unit operation and operating parameters. Important process objectives to define are:

• final product concentration
• feed volume reduction
• extent of buffer exchange
• contaminant removal specification.

Next, it is important to identify and quantify any criteria by which the success of the operation will be measured. The primary goals for successful protein processing are:

• high product yield
• high product quality (or activity)
• high product purity
• controlled bioburden and endotoxin.