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Blood products, which are biologically active compositions derived from the plasma of healthy donors via separation and purification methodologies or biotechnological processes, inherently possess the propensity to transmit blood-borne pathogens due to the utilization of human plasma as their source material. Historically, the absence of robust virus inactivation or removal protocols has precipitated contamination episodes with viruses during the manufacturing of blood products. Notably, during the mid-1990s, it was documented internationally that suboptimal modifications in screening reagents and the omission of efficacious virus inactivation measures inadvertently facilitated the transmission of hepatitis C virus (HCV) to recipients of intravenous immunoglobulin (IVIG). Furthermore, in contemporary times, instances have arisen wherein heat-processed coagulation factor concentrates have inadvertently conveyed human parvovirus B19.
Consequently, to mitigate the risk of viral contamination in biological products and to ascertain the biological safety of the end products, regulatory bodies domestically and internationally have enacted stringent guidelines. These directives stipulate that the manufacturing process of biological products must incorporate steps capable of efficiently inactivating or removing viruses. Such virus inactivation/removal methodologies are of paramount importance and represent a crucial component in the safety assurance of blood products. The Viruclear virus removal filters by Cobetter are engineered utilizing cutting-edge membrane technology and sophisticated manufacturing techniques, boasting superior virus retention capabilities and protein flux. Subject to rigorous quality assurance and performance evaluations, every filter is warranted to conform to the highest industry benchmarks, effectively purging virus particles from blood products and guaranteeing their safety.
This treatise delineates the efficacy outcomes of Cobetter Viruclear RC series viral removal filters within the context of manufacturing factor IX and fourth-generation intravenous immunoglobulin (IVIG), whilst undertaking a comparative analysis and selection of the pertinent processes.
Case Study in Virus Filtration of Coagulation Factor IX
Test Conditions:
- Concentration：1 g/L
- 3 lots of F-IX samples run in parallel
- Constant pressure at 29.0 psi
- Prefiltered with Corevital™ SMD 0.2/0.1 μm (Virus removal prefilter)+Viruclear RC
- 4% volume PPV spiked
Case Study in Virus Filtration for Fourth-Generation Intravenous Immunoglobulin (IVIG)
Test conditions：
- Sample：4th generation IVIG
- Concentration: 41 g/L
- Constant pressure: 29.0 psi
- Duration: 16-20 hours
- Prefiltered with Company M X0HP (Virus removal prefilter)+Viruclear RC H
Comparison of Virus Filtration Performance Between Cobetter and Competitors in Fourth-Generation IVIG
Head-to-head testing conditions：
- 50 g/L 4th generation IVIG intermediate（Frozen-and-thawed）
- Prefiltered with Corevital™ SMDA 0.2/0.1 μm (Virus removal prefilter) separately
- Filtered under vendor’s recommended pressure for constant pressure virus filtration.
Comparison of Filtration Performance of Cobetter Virus Removal Filters Viruclear RC and RC H Series in 50 g/L IVIG Filtration Test
- Inline filtration with Viruclear PNY Nylon pre-filter
- Constant pressure：30psi
- After 16 h, the end mass capacity of Viruclear RC H was 8.7 kg/m², 4 times higher than Viruclear RC.
Viruclear RC Series Virus removal filter parameters
Cobetter has consistently dedicated itself to the pursuit of technological breakthroughs and the enhancement of product offerings, thereby continually addressing the stringent requirements of safety, efficiency, and reliability within the blood products sector. We eagerly anticipate collaborating with an expanding array of partners to collectively script a novel epoch in this industry. Should you have any requirements pertaining to testing services, please do not hesitate to reach out to Cobetter's business representatives or send email to us for assistance. We are poised to deliver an exceptional experience that meets your expectations.
