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Product Name: Olaratumab Maleate
Synonyms: Olaratumab, LY3012207, Monoclonal Antibody to PDGFRα
CAS Number: 1228105-51-8
Manufacturer: Eli Lilly and Company
Use: Investigational drug for oncology, specifically for soft tissue sarcoma
Contact Information: Eli Lilly Worldwide Safety, Emergency phone: +1-317-276-2000
Recommended Use: Research and pharmaceutical manufacturing
GHS Classification: Not classified as hazardous according to OSHA HCS or EU CLP
Physical Hazards: None expected for biological monoclonal antibody in solid or lyophilized form
Health Hazards: May cause allergic reactions in sensitive individuals; low toxicity expected via non-clinical exposure
Environmental Hazards: No significant hazards identified based on available data for biological preparations
Signal Word: None
Hazard Statements: Not hazardous under GHS
Precautionary Statements: Handle as a biological agent; avoid ingestion, inhalation, contact with skin and eyes
Other Hazards: Dust may cause minor irritation. Possible hypersensitivity reactions for individuals with pre-existing allergies.
Chemical Name: Olaratumab Maleate
Concentration: Typically >95% pure Olaratumab (monoclonal antibody), trace excipients
Formulation Components: Olaratumab (active), mannitol, glycine, polysorbate 80, sodium chloride, water for injection
Impurities: Trace protein fragments, manufacturing process residues controlled within regulatory guidelines
Ingredient Classification: Biologic, humanized monoclonal IgG1 kappa antibody
Inhalation: Remove to fresh air promptly. Seek medical attention if symptoms develop (cough, respiratory irritation, allergic reaction).
Skin Contact: Wash thoroughly with soap and water. Remove contaminated clothing and launder before reuse. Report rash or irritation to a healthcare provider.
Eye Contact: Rinse eyes cautiously with water for several minutes. Remove contacts if easily possible. Continue rinsing if irritation develops. Seek medical attention if symptoms persist.
Ingestion: Rinse mouth with water. Do not induce vomiting unless instructed by a medical professional. If large amounts are ingested, immediately contact poison control or a physician.
Most Important Symptoms and Effects: May produce mild irritation, allergic sensitization, or rarely, hypersensitivity reactions (such as rash, swelling, or anaphylaxis in predisposed individuals).
Notes to Physician: Treat symptomatically. Observe for delayed allergic or immune-mediated reactions even after initial asymptomatic period.
Suitable Extinguishing Media: Use water spray, dry chemical, foam, or CO2. Select extinguishing agent appropriate for surrounding materials.
Specific Hazards Arising from Material: Product is nonflammable and does not support combustion. Proteinaceous material may decompose to produce carbon oxides, nitrogen oxides under fire conditions.
Protective Equipment and Precautions: Firefighters should wear self-contained breathing apparatus and full protective clothing for biological material fires.
Special Procedures: Prevent runoff from fire control or dilution from entering drains, sewers, or watercourses.
Personal Precautions: Wear suitable PPE, including gloves, eye protection, and lab coat. Avoid direct contact with skin, eyes, or clothing.
Environmental Precautions: Prevent further release. Keep away from drains, surface water, and soil.
Cleanup Methods: Collect spillage using soft absorbents. Clean surface with a detergent solution and dispose of residues following local biohazard protocols.
Spill Reporting: Inform responsible authorities if significant release occurs outside controlled environment.
Handling: Work with this product in a well-ventilated space or biological safety cabinet. Minimize dust generation. Use barrier protections—gloves, lab coat, protective eyewear.
Storage: Store at 2–8°C in original container, protected from light and physical damage. Avoid repeated freeze/thaw cycles.
Incompatibility: Avoid heat, strong acids, or bases, oxidizing and reducing agents.
Hygiene Measures: Do not eat, drink, or smoke in work area. Wash hands thoroughly after handling.
Occupational Exposure Limits: No established OEL specific to Olaratumab. Use pharmaceutical control bands or internal guidelines.
Engineering Controls: Operate in certified biosafety cabinet or fume hood. Use closed systems if available.
Personal Protective Equipment (PPE):
Gloves—nitrile or latex recommended.
Eye/Face—safety glasses or goggles.
Skin Protection—lab coat, closed-toe shoes.
Respiratory Protection—if aerosol generation expected, use N95 or equivalent.
Environmental Controls: Use local exhaust to capture dust or aerosols.
Physical State: Lyophilized powder or clear, colorless to slightly yellow solution
Odor: Odorless or faint proteinaceous odor
Molecular Weight: ~146 kDa (monoclonal antibody)
pH: 5.0–6.5 (reconstituted solution)
Solubility: Freely soluble in water
Boiling Point/Melting Point: Not applicable for biological macromolecules
Vapor Pressure: Not relevant
Evaporation Rate: Not applicable
Flash Point: Not applicable
Partition Coefficient (log Kow): Not determined
Viscosity: Not applicable
Explosive Properties: No explosive properties present
Chemical Stability: Stable under normal storage (2–8°C) and recommended handling conditions
Reactivity: Inert under ambient temperatures and pressures
Possibility of Hazardous Reactions: None known under standard storage/use. Degradation may produce small amounts of carbon and nitrogen oxides if exposed to fire.
Conditions to Avoid: High temperatures, repeated freeze/thaw, direct sunlight
Incompatible Materials: Strong oxidizers/reducers, acids and alkalis
Hazardous Decomposition Products: Not expected with normal use. Fire may produce typical protein combustion products.
Acute Toxicity: Very low—data on similar monoclonal antibodies show limited toxicity to humans or animals outside intended effects.
Chronic Toxicity: Long-term effects resemble exposure to biological proteins; minimal unless individual allergic or immunocompromised.
Routes of Exposure: Inhalation, skin/eye contact, ingestion (occupational)
Symptoms: Mild irritation, possible allergic reaction, rare cases of systemic hypersensitivity.
Carcinogenicity: Not classified as carcinogen by IARC, NTP, or OSHA.
Mutagenicity: No mutagenic potential in biological systems assumed.
Reproductive Toxicity: No direct studies available; use caution in pregnant or lactating individuals.
Target Organ Effects: None established.
Medical Considerations: Individuals with existing allergies or immune disorders might experience greater sensitivity.
Ecotoxicity: Not anticipated to pose significant environmental hazards due to proteinaceous, biodegradable nature.
Persistence and Degradability: Rapidly degrades by proteolytic enzymes and microbial activity in environment.
Bioaccumulation Potential: Minimal, does not persist or bioaccumulate.
Mobility in Soil: Water-soluble, likely disperses and degrades readily.
Other Adverse Effects: None significant at expected laboratory or clinical trial concentrations.
Waste Treatment Methods: Dispose of surplus product, waste material, and contaminated packaging as biomedical waste.
Incineration: Preferred method for complete destruction in an approved facility.
Local Disposal Regulations: Follow all local, regional, national, and international legislation for pharmaceuticals and biological agents.
Additional Precautions: Do not discharge in environment or to sewer system.
UN Number: Not regulated for transport under UN, DOT, ADR, IATA rules
Transport Hazard Class: Non-hazardous
Packing Group: Not applicable
Shipping Conditions: Ship at 2–8°C with cold packs. Abstain from extreme conditions or physical shock.
Proper Shipping Name: Olaratumab Maleate Solution or Lyophilized Powder
Special Precautions: Secure packaging, sealed, labeled for biohazard if appropriate for research or clinical trial shipment.
OSHA Regulation: Biological material. Not subject to OSHA specific chemical standards.
EPA Regulation: Not listed as hazardous waste.
EU Classification: Not classified as dangerous under EU Directive 67/548/EEC or Regulation EC No 1272/2008 (CLP).
TSCA Status: Exempt as a biological pharmaceutical product.
WHMIS (Canada): Exempt (drugs and biologics).
Other International Regulations: Complies with biotechnology and pharmaceutical safety guidelines in most jurisdictions.
Labeling Requirements: Pharmaceutical and investigational agent; specific application, lot, and safety warning labels required.
