In the Spotlight December 2011

Editors' Picks of Pharmaceutical Science & Technology Innovations

Biopharmaceuticals, such as vaccines, have become an important part of the drug industry's product portfolios. Several drugmakers will rely on these therapies to help soften the blow of coming patent expirations. In various ways, this month's products are intended to help the industry produce biopharmaceuticals efficiently, at large scales, and under the appropriate conditions. Sartorius now offers magnetic mixers in larger sizes than before. Compounding cleanrooms from Terra Universal help drugmakers meet US Pharmacopeial standards for sterility. Chromatography resins from EMD Millipore are intended to help companies purify antibodies quickly and efficiently.

Cation exchanger offers direct capture of recombinant proteins

EMD Millipore's Eshmuno chromatography resins are ion exchangers designed for fast and efficient purification of antibodies. The new multimode cation exchanger Eshmuno HCX media was specifically designed for the direct capture of recombinant proteins at high salt concentrations. Eshmuno's tentacle technology creates a multipoint interaction with the biopharmaceutical, thus resulting in increased binding capacities. The hydrophilic polyvinyl ether base allows for high flow rates and expedited processing.

EMD Millipore Eshmuno HCX resin www.millipore.com

PharmPrep P sorbent, part of the company's portfolio of chromatography media, features particles that have a perfect spherical shape. These particles are designed to pack columns more efficiently and with more stable results than sorbents with irregular materials. The two sizes (i.e., 10 and 20 μm) of the PharmPrep P sorbent enable the user to change to larger particles to increase productivity by operating preparative columns at increased flow rates. The sorbent has a pore diameter of 100 Å (10 nm) and can fit easily into the polishing step of small peptides and other biopharmaceutical and pharmaceutical APIs.

Single-use mixing systems for large volumes

Sartorius Stedim Biotech has expanded its standard range of Flexel magnetic mixers. The mixers, previously ranging in capacity from 50 to 1000 L, are now available in volumes of 1500 and 2000 L. The single-use system is designed for aseptic mixing in process-development and manufacturing applications. It is appropriate for biopharmaceutical processes that require powerful mixing torque, such as buffer preparation, media preparation, product resuspension, and homogenization applications. A stainless-steel cross mount on a pulley system enables the single-use bag to be unfolded for easy filling and optimal drainage. Its mixing is based on a bottom-mounted, magnetically driven impeller capable of providing high-torque mixing in large liquid volumes.

Sartorius Stedim Biotech Flexel for magnetic mixers www.sartorius-stedim.com

Compounding cleanrooms comply with USP <797>

Terra Universal's compounding cleanrooms are suitable for compounding sterile injectables and other preparations in accordance with US Pharmacopeia <797> standards. An ISO 5 (Class 100) primary processing area with three high-efficiency particulate air filter–fan units provides a total of 1950 cfm (3315 m³/h) of 99.99% particle-free air (measured at 0.3 μm diameter).

Terra Universal Compounding cleanroom www.terrauniversal.com

The cleanrooms' fan–filter units exceed USP <797> particle-count and air-change requirements between the buffer room and the antechamber room. Users have a choice of polycarbonate and static-dissipative polyvinyl chloride panels. A powder-coated steel support frame creates a rigid, durable structure that requires no external bracing or ceiling support. The unit's sliding vinyl curtain creates a separate antechamber that offers another level of protection to the buffer room from the ambient environment. The antechamber is also under positive pressure, and personnel can don garb or prepare materials, thus leaving the buffer room strictly for needed equipment.