Description

Certolizumab is a recombinant, humanized antibody Fab' fragment conjugated to polyethylene glycol (PEG) that specifically targets and neutralizes tumor necrosis factor-alpha (TNF-α). This targeted mechanism of action makes it a critical therapeutic agent for managing chronic inflammatory conditions. It is primarily utilized in the pharmaceutical and biotechnology sectors for the formulation of advanced biologic drugs. Certolizumab CAS NO 428863-50-7 represents a high-purity active pharmaceutical ingredient (API) essential for ensuring the efficacy and safety of the final medicinal product.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of biologic therapeutics for autoimmune diseases.
• Rheumatoid Arthritis Treatment: Formulation of medications to reduce inflammation and halt disease progression.
• Psoriatic Arthritis Therapy: Key component in drugs designed to alleviate joint and skin symptoms.
• Ankylosing Spondylitis Management: Used in therapeutics targeting spinal inflammation and pain.
• Plaque Psoriasis Treatment: Incorporated into formulations for moderate-to-severe skin plaque management.
• Crohn's Disease Therapy: Essential for biologic drugs used to induce and maintain clinical remission.
• Research & Development: Critical reference standard and material for preclinical studies and bioanalytical method development.
• Biosimilar Development: Serves as a reference molecule for the development and analytical characterization of biosimilar products.

Basic Information

Product Name	Certolizumab
CAS No.	428863-50-7
Molecular Formula	C2118H3254N562O669S16 (Approximate, for PEGylated Fab' fragment)
Molecular Weight	~91 kDa (Approximate)
Synonyms	Certolizumab Pegol; CDP870; Cimzia; TNF-α Inhibitor PEGylated Fab' Fragment; Anti-Human TNF-α PEGylated Fab'; Recombinant Humanized Anti-TNF Fab' Monoclonal Antibody Fragment; PEG-Anti-TNF Fab'
EINECS	Contact for details

Quality Control

Our Certolizumab is manufactured under strict cGMP conditions to ensure the highest standards of purity and biological activity. Each batch undergoes a comprehensive suite of analytical tests, including identity confirmation by peptide mapping and mass spectrometry, purity assessment by size-exclusion and ion-exchange HPLC, and potency testing via cell-based bioassays. Certificates of Analysis (COA) detailing specifications for protein content, PEGylation ratio, endotoxin levels, and residual host cell proteins are available upon request.

Storage

Preserve in a tightly closed container, protected from light. For long-term stability, store at -20°C or below. Avoid repeated freeze-thaw cycles. The product is hygroscopic (moisture-sensitive) and should be handled under controlled, low-humidity conditions when reconstituted or aliquoted.

Specification

Item	Specification
Appearance	White to off-white lyophilized powder or solid
Identification (Peptide Map)	Conforms to reference standard
Purity (SEC-HPLC)	≥ 98.0% (Monomer)
Protein Content (UV)	90% - 110% of label claim
Potency (Cell-based Assay)	90% - 125% of reference
Endotoxin	< 1.0 EU/mg
Moisture (K.F.)	≤ 3.0%

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