Satralizumab Biosimilar – Research Grade
$300.00 – $5,000.00
Safety Data Sheet
Version 2.5 SDS Revision Date 8/31/2022
www.ichor.bio
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IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING
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Product Identifiers
Product Name: Satralizumab Biosimilar - Research Grade
Catalogue Number: ICH5106 -
Relevant identified uses of the substance or mixture and uses advised against
Identified Uses:
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Details of the supplier of the safety data sheet
Company: ichorbio Ltd, Boston House, Grove Business Park
Downsview Road, Wantage, OX12 9FF, UK
Internet: www.ichor.bio
Email address: hello@ichor.bio
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Emergency Telephone Number
Emergency Tel: UK: +44 7749 955031
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HAZARDS IDENTIFICATION
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Classification of the substance or mixture
This substance does not meet the classification criteria of the EC Directives 67/548/EEC, 1999/45/EC, 1272/2008 [CLP], GHS or 29 CFR 1910.1200 [OSHA].
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Label Elements
The product does not need to be labelled in accordance with EC directives or respective national laws.
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Other Hazards
None
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COMPOSITION/INFORMATION ON INGREDIENTS
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Substances
Not applicable
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Mixtures
This product does not contain hazardous chemicals at concentrations of 1% or greater. This product is not known to contain carcinogens at concentrations of 0.1% or greater.
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FIRST AID MEASURES
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Description of first aid measures General Advice
Consult a doctor and show this safety data sheet.
If Inhaled
Remove to fresh air and monitor breathing. If breathing becomes difficult, give oxygen. If breathing stops, give artificial respiration. Consult a doctor.
In Case of Skin Contact
Immediately wash skin with copious amounts of soap and water for at least 15 minutes. Remove contaminated clothing and shoes and wash before reuse. Consult a doctor.
In Case of Eye Contact
Flush with copious amounts of water for at least 15 minutes. Consult a doctor.
If Swallowed
Rinse mouth with water. Do not induce vomiting unless directed to do so by medical personnel. Never give anything by mouth to an unconscious person. Consult a doctor.
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Most important symptoms and effects, both acute and delayed
To the best of our knowledge, the chemical, physical and toxicological properties have not been thoroughly investigated.
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Indication of immediate medical attention and special treatment needed
Show this safety data sheet to the doctor in attendance. Immediate medical attention is required.
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FIRE-FIGHTING MEASURES
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Extinguishing Media
Suitable extinguishing media
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
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Special hazards arising from the substance or mixture
In combustion, it may emit toxic fumes.
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Precautions for fire-fighters
Wear suitable protective clothing to prevent contact with skin and eyes and self-contained breathing apparatus.
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ACCIDENTAL RELEASE MEASURES
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Personal precautions, protective equipment and emergency procedures
Do not take action without suitable protective clothing - see section 8 of SDS. Evacuate personnel to safe areas. Ensure adequate ventilation. Avoid breathing vapours, mist, dust or gas.
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Environmental precautions
Do not let product enter drains.
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Methods and materials for containment and cleaning up
Cover spillage with suitable absorbent material. Hold all material for appropriate disposal as described under section 13 of SDS.
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Reference to other sections
For required PPE see section 8. For disposal see section 13.
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HANDLING AND STORAGE
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Precautions for safe handling
Avoid inhalation, contact with eyes, skin and clothing. Avoid the formation of dust and aerosols. Use in a well-ventilated area. Keep away from sources of ignition. Avoid prolonged or repeated exposure.
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Conditions for safe storage, including any incompatibilities
Store in a cool, well-ventilated area. Keep away from direct sunlight. Keep the container tightly sealed until ready for use.
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Specific end uses
Not applicable.
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EXPOSURE CONTROLS/PERSONAL PROTECTION
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Control parameters
Components with workplace control parameters
Contains no substances with occupational exposure limit values.
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Exposure controls Appropriate Engineering Controls
Use in a fume hood where applicable. Ensure all engineering measures described under section 7 of SDS are in place. Ensure the laboratory is equipped with a safety shower and eyewash station.
Personal Protective Equipment Eye / Face Protection
Use appropriate safety glasses.
Skin Protection
Use appropriate chemical resistant gloves (minimum requirement use standard BS EN 374:2003). Gloves should be inspected before use. Wash and dry hands thoroughly after handling.
Body Protection
Wear appropriate protective clothing.
Respiratory Protection
If risk assessment indicates necessary, use a suitable respirator.
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PHYSICAL AND CHEMICAL PROPERTIES
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Information on basic physical and chemical properties
Appearance
Lyophilized white powder or clear liquid
Vapour Pressure
No data available.
Odor
Little to none
Vapour Density
No data available.
Odor Threshold
No data available.
Relative Density
No data available.
pH
No data available.
Solubility(ies)
No data available.
Melting / Freezing Point
No data available.
Partition Coefficient
No data available.
Boiling Point / Range
No data available.
Autoignition Temperature
No data available.
Flash Point No data available. Decomposition Temperature No data available. Evaporation Rate No data available. Viscosity No data available. Flammability (Solid, Gas) No data available. Explosive Properties No data available. Upper / Lower Flammability or Explosive Limits No data available Oxidising Properties No data available.
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Other safety information
No data available.
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STABILITY AND REACTIVITY
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Reactivity
Stable under recommended transport or storage conditions.
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Chemical stability
Stable under recommended storage conditions.
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Possibility of hazardous reactions
Hazardous reactions will not occur under normal transport or storage conditions. Decomposition may occur on exposure to conditions or materials listed below.
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Conditions to avoid
Heat, moisture.
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Incompatible materials
Strong acids/alkalis, strong oxidising/reducing agents.
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Hazardous decomposition products
Strong acids/alkalis, strong oxidising/reducing agents.
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TOXICOLOGICAL INFORMATION
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Information on toxicological effects Acute Toxicity
Classified based on available data Skin Corrosion / Irritation Classified based on available data Serious Eye Damage / Irritation Classified based on available data Respiratory or Skin Sensitization Classified based on available data Germ Cell Mutagenicity Classified based on available data Carcinogenicity
Classified based on available data
Reproductive Toxicity
Classified based on available data
Specific Target Organ Toxicity - Single Exposure
Classified based on available data
Specific Target Organ Toxicity - Repeated Exposure
Classified based on available data
Aspiration Hazard
Classified based on available data
Symptoms / Routes of Exposure
Inhalation: There may be irritation of the throat with a feeling of tightness in the chest. Ingestion: There may be irritation of the throat.
Skin: There may be mild irritation at the site of contact.
Eyes: There may be irritation and redness. Delayed / Immediate Effects: No known symptoms.
Additional Information
Classified based on available data
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ECOLOGICAL INFORMATION
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Toxicity
No data available.
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Persistence and degradability
No data available.
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Bioaccumulative potential
No data available.
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Mobility in soil
No data available.
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Results of PBT and vPvB assessment
No data available.
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Other adverse effects
No data available.
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DISPOSAL CONSIDERATIONS
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Waste treatment methods Product
Transfer to a suitable container and arrange for collection by a specialised disposal company in accordance with national, regional, or local legislation.
Contaminated Packaging
Dispose of in a regulated landfill site or other method for hazardous or toxic wastes in accordance with national, regional, or local legislation.
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TRANSPORT INFORMATION
Classified according to the criteria of the UN Model Regulations as reflected in the IMDG Code, ADR, RID, DOT and IATA.
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UN-Number
Does not meet the criteria for classification as hazardous for transport.
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UN proper shipping name
Does not meet the criteria for classification as hazardous for transport.
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Transport hazard class(es)
Does not meet the criteria for classification as hazardous for transport.
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Packaging group
Does not meet the criteria for classification as hazardous for transport.
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Environmental hazards
Does not meet the criteria for classification as hazardous for transport.
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Special precautions for users
Does not meet the criteria for classification as hazardous for transport.
Additional Transport Information
Does not meet the criteria for classification as hazardous for transport.
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REGULATORY INFORMATION
This safety datasheet complies with the requirements of Regulation (EC) No. 453/2010.
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Safety, health and environmental regulations/legislation specific for the substance or mixture
TSCA (Toxic Substances Control Act) : Not applicable. SARA 313 : Not applicable.
SARA 311/312 : Not applicable.
CERCLA Reportable Quantity : California Proposition 65 : Not applicable.
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Chemical safety assessment
A Chemical Safety Assessment has not been made for this product.
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OTHER INFORMATION
Further Information
Copyright © 2022 ichorbio Ltd
This company shall not be held liable for any damage resulting from handling or from contact with the above product. This material must only be handled by suitably qualified experienced scientists in appropriately equipped and authorised facilities. The above information is believed to be correct but does not purport to be all inclusive and should be used as a guide only for experienced personnel. Always consult your safety advisor and follow appropriate local and national safety legislation. The absence of warning must not, under any circumstance, be taken to mean that no hazard exists.
End of safety data sheet
Satralizumab Biosimilar – Research Grade
ichorbio’s Satralizumab biiosimilar is for Research Use Only (RUO) and not for therapeutic use.
IL-6R
This biosimilar is available in the following sizes:
1mg, 5mg, 10mg, 20mg, 50mg, 100mg
Human IgG2(C131S/R133K/E137G/C219S/H264Q/R351Q/S374A/Q415E/N430A)-Kappa
CHO Cells
Human
Uses the same sequence as the therapeutic antibody Satralizumab
Detects human IL-6R. This non-therapeutic antibody uses a similar sequence to the therapeutic antibody Satralizumab.
This monoclonal antibody was purified using multi-step affinity chromatography methods such as Protein A or G depending on the species and isotype.
5mg/ml
Sterile, preservative-free, solution in PBS. BSA and Azide free.
>95% by SDS-PAGE
≤ 1.0 EU/mg as determined by the LAL method
This antibody is stable for at least 4 weeks when stored at 2-8°C. For long term storage, aliquot in working volumes without diluting and store at – 20°C or -80°C. Avoid repeated freeze thaw cycles.
Functional Assays
This biosimilar is for research use only (RUO): it is not for diagnostic or therapeutic procedures and cannot be purchased by patients.
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