Anti-Human C5 (Ravulizumab) – Fc Muted™

This biosimilar antibody is aseptically packaged and formulated in 0.01 M phosphate buffered saline (150 mM NaCl) PBS pH 7.2 - 7.4 with no carrier protein, potassium, calcium or preservatives added. Due to inherent biochemical properties of antibodies, certain products may be prone to precipitation over time. Precipitation may be removed by aseptic centrifugation and/or filtration.

Liquid

Recombinant biosimilar antibodies are manufactured in an animal free facility using only in vitro protein free cell culture techniques and are purified by a multi-step process including the use of protein A or G to assure extremely low levels of endotoxins, leachable protein A or aggregates.

To protect mouse colonies from infection by pathogens and to assure that experimental preclinical data is not affected by such pathogens, all of Leinco’s recombinant biosimilar antibodies are tested and guaranteed to be negative for all pathogens in the IDEXX IMPACT I Mouse Profile.

Functional grade biosimilar antibodies may be stored sterile as received at 2-8°C for up to one month. For longer term storage, aseptically aliquot in working volumes without diluting and store at -80°C. Avoid Repeated Freeze Thaw Cycles.

Research Use Only

2 – 8° C Wet Ice

This non-therapeutic biosimilar antibody uses the same variable region sequence as the therapeutic antibody Ravulizumab. ALXN-1210 binds with high affinity and specificity to the complement protein C5.

Complement component 5 (C5) is a crucial protein in the complement system, part of the body’s immune response. It is synthesized in the liver. It circulates in the blood as an inactive precursor. When triggered, C5 splits into C5a and C5b. C5a acts as an inflammation promoter and attracts immune cells to the sites of infection. C5b kickstarts the creation of a membrane attack complex (MAC), which creates pores in the membranes of pathogens, leading to their destruction. Irregularities in C5 activation are linked to illnesses such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)^1,2.

ALXN-1210, also known as ravulizumab, is a human monoclonal antibody. This antibody specifically targets and inhibits C5, preventing its cleavage into C5a and C5b, thus blocking (MAC) formation. Ravulizumab serves as a lasting inhibitor of C5 designed for effect with less frequent dosing compared to its precursor eculizumab. Clinical studies have shown that ravulizumab effectively treats conditions like PNH and aHUS offering patients convenience and quality of life due, to its dosing intervals^3-5.

The complement component C5 is primarily found in the plasma and extracellular matrix. It is synthesized in the liver and then secreted into the bloodstream.

C6

1. Henes JK, Groga-Bada P, Schaeffeler E, et al. Pharmgenomics Pers Med. 2021;14:893-903.
2. Fredslund F, Laursen NS, Roversi P, et al. Nat Immunol. 2008;9(7):753-760.
3. McKeage K. Drugs. 2019;79(3):347-352.
4. Ravulizumab: A Review in Atypical Haemolytic Uraemic Syndrome - PubMed. Accessed August 11, 2024. https://pubmed.ncbi.nlm.nih.gov/33738756/
5. Röth A, Rottinghaus ST, Hill A, et al. Blood Adv. 2018;2(17):2176-2185.
6. RAVMP - Overview: Ravulizumab Monitoring Panel, Serum. Accessed August 11, 2024. https://www.mayocliniclabs.com/test-catalog/Overview/618645