Biotechnology is reconginsied as the technology by which the worlds next generation of medicines and vaccines will be produced.
For all your depth, membrane and sterile filtration requirements 3M Purification offers cost-effective and robust solutions which help optimize your drug development, RD&E and Industrial Production.
3M Purification can draw upon over 45 in house technology platforms to deliver the solutions that you need today and to partner with you on the development of new products to address your needs of tomorrow.
3M™ Zeta Plus filters provide a solution for an efficient and economic purification of biotechnological products. They have been continually developed to address the needs of the Biotechnology Industry, providing cost effective solutions for cell harvesting with the capability of handling large levels of cell debris and biomass. The lastest grades of ZA Formulation also have the capability to significantly reduce levels of DNA and HCP providing increased levels of protection for the more sensitive down stream processes such as chromatography.
In addition to final filling the 3M™ LifeASSURE™ PDA sterilizing grade of filters are used for the protection of chromatography columns and membrane crossflow systems. Incorporating PES filtration media they are benchmarked to be low protein binding and assembled in cartridge formats which offer increased surface area for longer life and smaller systems.
In order to receive the best possible service and solution for your Biotechnology Downstream Purification contact us
In a biotechnology process cells or cell constituents are used for the production of therapeutic proteins.
A classical manufacture process for the production of biopharmaceuticals consists of various upstream and downstream systems. Upstream the development of production cells, the preparation of media, fermenters and inoculants as well as the fermentation of cell systems take place.
In biotech companies 3M™ Zeta Plus EXT filters are successfully used downstream for the clarification and purification of biomass during cell harvest. This partly happens through separators or, in case of single use production systems, directly through a 3M™ Zeta Plus EZP system. For further elimination of particles and biomass after a sterile filtration with 3M™ LifeASSURE PDA product isolation takes place through different chromatography steps.
HCP Reduction
Proteins of non-human species can lead to immune reactions when parenterally administered and therefore need to be reduced. The main source of contamination when manufacturing therapeutic proteins is the cell line used. Amongst other things host cell proteins rank as process-related contaminations. The World Health Organization (WHO) provides miscellaneous specifications of ppm/rh protein per therapeutic dose as contamination limit.
Different studies on the filtration of cell solutions with 3M™ Zeta Plus EXT ZA have shown that HCP can be successfully reduced through depth filtration with positively charged 3M™ Zeta Plus ZA material during cell harvest. This also applies to later process steps, e.g. after protein A columns.
DNA Reduction
During the production of therapeutic proteins with transformed cell lines the risk of a transfer of host cell DNA fragments exists. Amongst other things double-stranded DNA of host cell organisms is a key source for contamination in the biotechnological manufacturing process and has to maximally amount to a quantity between 0,1 ng (Wolter and Richter, 2005) and 10 ng (WHO, 1998) per therapeutic dose.
In filtration studies on 3M™ Zeta Plus EXT ZA a 300-fold DNA reduction during cell harvest could be achieved with a depth filtration of cell suspensions through the charged 3M™ Zeta Plus EXT ZA. These results are confirmed by depth filtration of protein A eluate.
Endotoxin Removal
Endotoxins (pyrogenes) are lipopolysaccharides (LPS) from the cell membrane outer layers of gram-negative bacteria, like e.g. E.coli. Endotoxins can cause fever reactions in humans when parenterally administered and therefore have to be removed from the processes.
These contaminations naturally occur during e.g. bacterial fermentation processes, but are also partially transferred by humans or by polluted water systems at manufacturing.
Endotoxins are very resistant to temperature and pH fluctuations. That is why adsorptive removal processes have proven to be successful in endotoxin reductions.
Endotoxins exhibit a negative charge in aqueous or protein solutions as of pH 2. Thus the endotoxins can be adsorbed with positively charged filter media.
For this purpose 3M Purification offers positively charged nylon membranes, e.g. the 3M™ LifeASSURE 020SP series, which can either act as a particle or sterile filter. In addition the positively charged 3M™ Zeta Plus EXT ZA depth filters with their comparatively thick filter layers are able to remove by far the most endotoxins thanks to its large charge and multitude of binding sites. Also activated carbon media like 3M™ ZetaCarbon are ideal for endotoxins removal.
Pre-Filtration / Particle Filtration
A so-called pre or particle filtration is often used in the pharmaceutics and biotechnology industry for clarification and/or particle reduction and:
maintaining the product quality, e.g. through elimination of precipitates after bottling
making further process stages easier, e.g. purification in subsequent biological/biotechnological manufacturing processes
timely removal of contaminants for the protection of further processes
greater efficiency during the overall process.
Filter media guarantee consistent quality of service media, such as water, alkalis, acids, buffers, growth media, gases and air.
For this purpose 3M Purification offers a variety of products:
bag filters
pleated polypropylene filter
depth filter cartridges
depth filter modules
micro filtration membrane cartridges such as 3M™ LifeASSURE PNA and PLA
