Birtamimab Biosimilar - Research Grade

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ICH5404-10mg
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Birtamimab Biosimilar - Research Grade

Endotoxin
≤ 1.0 EU/mg as determined by the LAL method
Purity
>90% by SDS-PAGE
Species Reactivity
Human
Target
SAA1
Concentration
>1mg/ml
Isotype
IgG1 - kappa
Host
CHO Cells
Antibodies Against The Same Target
Sequence
https://www.imgt.org/mAb-DB/
Buffer
ICH3002
Uniprot
P0DJI8
Gene Id
6288
Shipping Conditions
Blue ice
Background
Birtamimab Biosimilar - Research Grade (ICH5404) is an unconjugated, non-therapeutic research analogue built around the originator antibody Birtamimab (also known as NEOD001), supplied for research use only and not for clinical or diagnostic application. It is a human IgG1-kappa antibody offered at research-grade purity with low endotoxin, suitable for functional and in-vitro characterisation work and as a reference or control reagent. Birtamimab was developed as an investigational amyloid depleter for systemic AL (light-chain) amyloidosis, where it is described as binding a conformational epitope on misfolded immunoglobulin light chains present in soluble aggregates and in deposited amyloid fibrils, while sparing intact immunoglobulin and native circulating light chains. Note that the target listed on this catalogue record (SAA1, UniProt P0DJI8, serum amyloid A-1) is the precursor associated with AA/secondary amyloidosis and does not match the originator's published specificity; the two are distinct diseases and distinct proteins. This analogue lets investigators study binding, aggregate neutralisation and opsonisation-type mechanisms without sourcing clinical material. The originator Birtamimab is reported to recognise a cryptic, conformation-dependent epitope exposed on misfolded immunoglobulin light chains - both kappa and lambda - that is present in soluble toxic oligomers and in insoluble amyloid fibrils, but is hidden in properly folded native immunoglobulin and non-amyloidogenic free light chains. In AL amyloidosis, clonal plasma cells overproduce an unstable light chain that misfolds, forms cardiotoxic soluble aggregates, and deposits as amyloid in heart, kidney and other organs. The antibody's proposed mechanism is to neutralise the soluble aggregates and to promote macrophage-mediated antibody-dependent clearance of deposited fibrils. By contrast, SAA1 (serum amyloid A-1, P0DJI8), the target listed on this card, is a hepatic acute-phase apolipoprotein whose proteolytic fragments drive AA (secondary) amyloidosis - a separate entity. The card target and the drug's documented target therefore diverge; see flag.
Other Names
SAA, Serum amyloid A-1 protein
Purification Method
This monoclonal antibody was purified using Protein A
Formulation
Sterile, preservative-free, solution in PBS. BSA and Azide free.
Storage
This biosimilar is stable when stored at 2-8°C. For longer term storage (> 3 months) it is recommended to store this antibody at -20°C or -70°C.
Applications
Functional Assays
Application Notes
This biosimilar is for research use only (RUO): it is not for diagnostic or therapeutic procedures and cannot be purchased by patients.
Use
Products are for research use only. Not for use in diagnostic or therapeutic procedures.
Delivery Time
3-4 weeks
Suggested H1
Birtamimab (anti-SAA1) Biosimilar
Faq (q&a)

Q: Is the Birtamimab biosimilar available in gram quantities?

A: Yes — it is manufactured in scalable milligram to gram quantities to support bulk and high-throughput preclinical experiments.


Q: Is this research-grade Birtamimab biosimilar suitable for in vivo studies?

A: Yes, it is supplied in a low-endotoxin, in vivo-ready formulation intended for preclinical and in vivo research use only (RUO).


Q: What does the Birtamimab biosimilar target?

A: It is an unconjugated, non-therapeutic research analog of Birtamimab that binds SAA1; for research use only.


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Is the Birtamimab biosimilar available in gram quantities?

Yes — it is manufactured in scalable milligram to gram quantities to support bulk and high-throughput preclinical experiments.

Is this research-grade Birtamimab biosimilar suitable for in vivo studies?

Yes, it is supplied in a low-endotoxin, in vivo-ready formulation intended for preclinical and in vivo research use only (RUO).

What does the Birtamimab biosimilar target?

It is an unconjugated, non-therapeutic research analog of Birtamimab that binds SAA1; for research use only.

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