Produce Big, Start Small: Extension of Linear Scalability Millipore Offers a Range of Sterilizing-Grade Filter Capsules for Maximum Gain at Every Scale

Today’s fast-growing pharmaceutical and biotech industries need rapid and robust solutions for every step of the development process. To reduce time to market, each phase of scale-up has to be reliable and safe, while maintaining high performance. With this in view, Millipore has added new smaller sizes to its existing range of high-performance disposable filter capsules. The result is an extension of linear scalability to even smaller volumes.

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Volumes handled in biotech and pharmaceutical processes vary from less than a liter during research and development, to thousands liters at manufacturing scale. This means that scale-up requires a range of different sizes of filtration capsules. At every stage of the scale-up process, having the right filter area for the job can provide substantial cost savings by reducing the loss of valuable product. Understanding this issue, Millipore has made its Millipore Express high-performance filters available in the form of small-scale Opticap XL disposable capsules.

Opticap XL 150, 300 and 600 capsules, with surface areas of 150 cm2, 300 cm2 and 600 cm2 respectively, use similar materials of construction as those used in the rest of the Opticap XL and XLT range, which have areas of 1,300–17,100 cm2. The eight different capsule formats provide predictable filter performance and linear scale-up. There is a suitable capsule format for each application step, guaranteeing the highest possible reliability and the best process economics, with minimum product loss and maximum time saving.

A matter of the right membrane choice

Filtration needs also differ depending on the application and the media to be filtered. A fermenter needs upstream protection from Mycoplasma, for instance, whereas in post-harvest steps particles and bacteria have to be eliminated. Downstream, purified proteins must be transferred to the final filling step in relatively small quantities, yet with stringent protection against contamination.

Millipore provides different membrane pore sizes to meet these various application needs. Opticap XL capsules with Millipore Express SHR membranes and prefilter membranes are designed for fluid streams that require sterile filtration and Mycoplasma retention, such as cell culture media and media additives. The combination of 0.1 µm and 0.5 µm rated membrane layers provide reliable high retention and consistent capacity.

Minimum loss of product

Opticap XL with Millipore Express SHC is designed for sterile filtration of solutions with a high tendency to fouling, including concentrated proteins, serum-free media, biologicals, buffers and other process intermediates. Millipore has developed this 0.2 µm-rated double-layer filter type for all downstream filtration steps where the particle load and bioburden must be controlled with minimum loss of product.

For fluids that must be kept free of particulates

The SHF 0.2 µm-rated filter is designed for any fluid that must be kept free of particulates, including buffers, cleaning agents, process water and final products. These filters are currently available only for large flowrates, with areas starting at 1,600 cm2, but will become available for smaller volumes during 2008.

The expanded range of Millipore Express disposable capsules will help to strengthen the complete manufacturing process by ensuring maximum yield, improved process economics and reliability in filtration. According to Millipore, from pilot scale to full-scale production, the company has the right size and the right membrane type to meet any application need. Millipore support and expertise help to ensure accurate filter selection and effective validation.

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