Description

Spesolimab is a high-purity, humanized monoclonal antibody targeting the interleukin-36 receptor (IL-36R). This compound is a critical active pharmaceutical ingredient (API) for advanced therapeutic development, offering targeted immunomodulatory action. It is essential for pharmaceutical R&D and manufacturing entities focused on innovative biologic treatments for inflammatory and autoimmune conditions, such as generalized pustular psoriasis (GPP).

Application

• Primary Pharmaceutical API: Core active ingredient in the formulation of biologic drug products targeting IL-36 mediated pathways.
• Clinical Research Material: Used in preclinical and clinical trial studies for investigating efficacy and safety in autoimmune disorders.
• Reference Standard: Serves as a high-purity standard for analytical method development, validation, and quality control testing.
• Biologic Drug Development: Integral component in the development and scale-up of monoclonal antibody-based therapeutics.
• Process Development & Optimization: Used in downstream process development for purification and formulation studies.

Basic Information

Product Name	Spesolimab
CAS No.	2097104-58-8
Molecular Formula	Contact for details
Molecular Weight	Approx. 145 kDa (Contact for exact specification)
Synonyms	BI 655130; Anti-IL36R Monoclonal Antibody; IL-36 Receptor Antagonist; Spesolimab-brze; spesolimab (INN); Anti-Interleukin-36 Receptor Monoclonal Antibody
EINECS	Contact for details

Quality Control

Our Spesolimab is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure identity, purity, potency, and safety, meeting stringent standards for biologic APIs. A detailed Certificate of Analysis (COA) is provided with each shipment, documenting results for critical quality attributes including purity by SE-HPLC, host cell protein levels, and biological activity.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C to -80°C. Avoid repeated freeze-thaw cycles. This product is hygroscopic (moisture-sensitive) and should be handled under controlled, dry conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or clear to slightly opalescent solution
Identification (HPLC/MS)	Conforms to reference standard
Purity (SE-HPLC)	≥ 98.0% (Monomer)
Protein Content (UV/A280)	As per COA
Biological Activity (Cell-based assay)	As per COA
Endotoxin (LAL)	< 1.0 EU/mg
Host Cell Protein (HCP)	< 100 ppm
Sterility (Membrane Filtration)	Sterile

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.