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
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
Compounding cleanrooms comply with USP <797>
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.