Biotherapeutics virus removal filtration is one of the very booming technology adopting by biotechnology and pharmaceutical companies. Virus removability is based on size–exclusion mechanisms: viruses larger than the mean pore size become trapped.
The first virus removal filter in biotherapeutics, PlanovaTM, was launched in 1989. It is first filter developed specifically for removing viruses from biotherapeutic products such as biopharmaceuticals and plasma derivatives.
These filters are available in pore sizes to match the virus removal needs of particular product applications. They have more than two decades of proven safety and reliability in the international biopharmaceutical industry.
Implementation of a virus retentive filter is one of many steps a manufacturer will take to ensure product safety, since it is a critical component in the manufacture of biological therapeutics. The choice of a virus filter is driven mainly by robust virus retention.
Nevertheless, robust retention should be achieved as economically as possible. There are regulatory process and filter-related considerations which should take into account while selecting the right virus filter and in initiating filter optimization studies.
Planova filters offer an excellent combination of high protein yield, validated virus safety, and scalability.
Some. The risk of contamination with either known or unknown viruses in biological therapeutic products, produced using mammalian cell lines or human plasma products, has been demonstrated. Hence, regulatory agencies have mandated that manufacturers evaluate the risks of virus contamination and take necessary measures to mitigate these risks.
Moreover, the manufacturers are encouraged to ensure the purity of source materials, and to institute steps in the purification process that will clear endogenous and adventitious viruses.
Since biopharmaceuticals are mainly derived from human, animal, and plants; therefore scrutinized virus filtration procedure to avoid virus contamination in the production is required. This necessity of the procedure during the production of biologics is expected to lift the market in coming future.
Furthermore, leading biopharmaceuticals and biotechnology manufacturers are also involved in R&D to develop innovative biological products which lead the growth of this market.
The common biotherapeutics virus removal filters available in market are Planova 15N, Planova 20N, Planova 35N, Viresolve NFP, Viresolve NFR, ULtipor DV20, ULtipor DV50, Virosart CPV.
The global market for biotherapeutics virus removal filters market is segmented on basis of service type and geography:
- Segmentation by Virus Size
- 18-26 nm
- 28-30 nm
- 40-70 nm
- 80-130 nm
- Segmentation by Virus Clearance Filter
- Segmentation by End User
- Biotechnology and Pharmaceutical Companies
- Contract Research Organizations (CROs)
- Academic Institutes
On the basis of end user, the global biotherapeutics virus removal filters market has been segmented into biotechnology and pharmaceutical companies, contract research organizations (CROs), and academic institutes. Among these three, biotechnology and pharmaceutical companies, as end user to grow at a high growth rate, due to increasing research activity and high demand of virus filters.
On the basis of regional presence, global biotherapeutics virus removal filters market are segmented into five key regions viz. North America, Latin America, Europe, Asia Pacific, and Middle East & Africa.
North America remains dominant in the global biotherapeutics virus removal filters market due to increasing number of research going on monoclonal antibodies (mAb) and recombinant protein, which requires virus removal filters. Europe is expected to hold second largest market share in global biotherapeutics virus removal filters market.
However, stringent government regulation in Germany and France in terms of approval, restraining the growth of this market in European region. Emerging markets such as APAC and Latin America are expected to see delayed growth.
In the majority of the developed countries, the biotherapeutics virus removal filters are provided by the government or community-based programs. Some of the prominent players identified in global blood transfusion filters market are Asahi Kasei Medical, EMD Millipore, Pall Corporation, Sartorius AG.
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