Optimizing Adjuvant Filtration: A Technical Forum - Pharmaceutical Technology

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Optimizing Adjuvant Filtration: A Technical Forum
Experts discuss solutions for filter bacterial retention and related challenges. Contains online bonus material.

Pharmaceutical Technology
Volume 36, Issue 2, pp. 38-41, 56

Adjuvant type

PharmTech: Can certain types of adjuvants (e.g., surfactant-containing solutions) cause fewer problems with regard to filters' bacterial retention?

Bromm (Sartorius Stedim): A review of validation studies and field tests for a broader variety of fluid formulations indicates that low surface tension formulations, such as many adjuvants or adjuvanted vaccines, present a higher risk for bacterial penetration of sterilizing-grade membrane filters. Among such formulations, according to the data analyzed, liposome formulations present a higher risk than surfactant containing solutions. Therefore, the use of such formulations may be a suitable alternative to replace more critical formulations where applicable.

Martin (Pall): It is possible that certain adjuvants and related low surface tension fluids may be intrinsically less likely than others to cause reduced retention efficiency by membrane filters. However, there is insufficient data at this time to draw firm conclusions and make recommendations. In addition, awareness among vaccine producers that selection of surfactant-containing adjuvants and processing conditions can influence bacterial retention efficiency of sterilizing filters is not yet widespread. Until then, filter manufacturers must continue to work with vaccine developers to define appropriate membranes and optimize reasonable processing conditions to sterilize any vaccine formulation. Certainly, elaboration of an optimum adjuvant with such a goal would require an extensive amount of work and a very close partnership between filter manufacturers and vaccine producers.

Koklitis (3M): The choice of adjuvant is dependent on meeting the requirements of the process under consideration. The pros and cons of using a particular type of adjuvant must be considered and compared. When liposomes are selected as adjuvants their role as antigen carriers is utilized along with their immunological enhancement effect.

Powell (Asahi): These issues should be discussed with the membrane supplier's technical support teams and if they can't help, the filters must be screened to choose the best solution for the filter application. The answer depends on the membrane chemistry, but for large porosity filters, surfactant-containing solutions are typically not that large of a problem. Smaller porosity filters can be dramatically impacted in a negative way.


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