Equipment and Processing Report
PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the November 2011 edition from Sartorius Stedim Biotech and Thermo Fisher Scientific.
Sartorius Stedim Biotech
Membrane binds contaminants at high conductivities
The Sartobind STIC PA membrane from Sartorius Stedim Biotech uses free primary-amino ligands at high density to bind contaminants at high conductivities through ion exchange. Unlike traditional quaternary ammonium membranes, the Sartobind STIC PA membrane does not require the cation ion-exchange pools to be diluted to bind the negatively charged contaminants. This characteristic can help users reduce buffer consumption and buffer-tank costs. The Sartobind membrane also removes host-cell proteins, DNA, viruses, and endotoxins at salt conditions as high as 20 mS/cm.
The series of membranes includes six capsule sizes from 0.08 mL to 1.6 L. All of the membranes are suitable for flow-through polishing, and users can maintain a 4-mm bed height to scale up to larger devices. The membrane-adsorber capsules are plug-and-play devices that can be used like filters. Personnel can discard the materials after a single use, thus reducing validation costs.
Thermo Fisher Scientific
Roller bottles help improve yields and scale-up
Thermo Fisher Scientific has introduced its Thermo Scientific Nunc TufRol PS roller bottles for cell-culture production. Nunc TufRol PS roller bottles use polystyrene materials, thus minimizing the effort required to validate cell culture scale-up processes. Designed with indentations at the bottom to facilitate manual and automated handling, TufRol roller bottles are also available with vertical pleats to facilitate emptying and reduce product retention.
TufRol roller bottles were added to the existing Thermo Scientific Nunc InVitro PETG roller-bottle product line. Nunc InVitro PETG roller bottles are molded of polyethylene terephthalate, which is stronger than glass under normal culture applications. These bottles can withstand temperatures as low as –40 °C to accommodate freeze–thaw release protocols. Nunc InVitro roller bottles are available with a poly-D-lysine coating, which is used to promote cell attachment for cell lines that are difficult to grow. In addition, the bottles’ surface area of 1450 cm2 can result in larger product yields, compared with traditional roller bottles.