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
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.