API Purification - Pharmaceutical Technology

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PharmTech Europe

API Purification
Pharmaceutical Technology Europe speaks to Peter Koklitis, a technical filtration specialist at 3M's purification division, about the latest trends, techniques and technologies in API purification.


Pharmaceutical Technology Europe
Volume 23, Issue 9

How has the trend towards single-use technologies impacted API filtration processes?

As mentioned previously, there has been much innovation in the area of single-use systems. However, although such systems are being used in API filtration, particularly in API bioprocessing, disposable solutions do not necessarily suit all situations. The investment and maintenance costs of all process steps need to be calculated and then considered for both disposable and stainless steel systems. The calculations that contribute to forming a decision should include workers time, water, cleaning chemicals and waste disposal costs. The adoption of plastic encapsulated filters is also restricted when chemically aggressive solvents are used. Future process design technologies may yield novel reaction pathways, which use less challenging solvent systems, and such advances would contribute to widening the adoption of single-use components.

Single-use systems are also being used for highly potent APIs. These ingredients require special containment, but a range of solutions have been developed in this area, such as encapsulated filter media that can clarify harvests.

What are the latest trends in API filtration equipment/services?

Bioprocessing companies are achieving higher titres for their target API proteins, typically monoclonal antibody fragments. A consequence of this is to allow smaller bioreactors to be used with smaller facility design specifications in order to obtain the required amounts of product for clinical trials. These smaller throughput requirements have contributed to the increased use of single-use technologies for the purification process, as well as for the bioreactor. Consequently, demand has grown for single-use sterile connectors, membrane-chromatographic adsorbers, sensors and mixers, as well as production-scale filter capsules, containers and the bioreactors themselves. The standardisation of all these single-use components, with respect to materials and dimensions of connectors and fittings, is a user consideration. However, many of the design features and materials of these components will remain proprietary to specific manufacturers.

Peter Koklitis is a technical filtration specialist at 3M's Purification Division.


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