Material Safety Data Sheet
Biogen, Inc. 24-Hour Emergency Phone:
14 Cambridge Center 1 (800) 262 4363
Cambridge, MA 02142 Biogen Environmental Health & Safety:
(617) 679-2000 1 (617) 679 2236
Section 1. Identification
Product Name: Monoclonal Antibody 5c8
Chemical Name: Monoclonal Antibody 5c8
CAS Number: None
Substance: Humanized monoclonal antibody 5c8
Other Names or Code Numbers: BG9588, hu5c8, 5c8, Humanized 5c8
Section 2. Composition / Information on Ingredients
Components % Optional OSHA PEL ACGIH TLV OTHER STANDARDS
hu5c8 >95% pure no no no
(bulk intermediate
and final product)
hu5c8 final product is in a buffer solution containing millimolar
concentrations of sodium phosphate and sodium chloride. No hazardous
components are present at greater than 1% concentration.
Section 3. Hazards Identification
General Statement: Humanized 5c8 is a genetically humanized
monoclonal antibody produced in a NSO murine myeloma
cell line. It is specifically active on the CD40
Ligand/CD40 pathway that is involved in the generation
of certain antigens and in the regulation of certain
cellular immune responses. The chemical, physical and
toxicological properties of this material have not been
thoroughly investigated. Exercise care to prevent
contact or exposure.
Carcinogen Status: OSHA: No NTP: No IARC: No
Carcinogen Statement:
Mutagenic Effects: No data available
Teratogenic Effects: No data available
Reproductive Effects: No data available
Neurotoxic Effects: No data available
Section 4. First Aid Measures
If Inhaled: Remove to fresh air. Get medical attention. If
breathing has stopped, give artificial respiration.
Treat symptomatically and supportively.
If Swallowed: Wash mouth out with water and seek medical attention.
In Case of Skin or Eye Contact: No data available. Irritant effects
are possible. Flush eyes at least 15 minutes with
water. Wash exposed skin with soap and water. Contact
physician if irritation persists.
Skin Absorption: No data available
If Injected: No data available
Medical Conditions Aggravated by Exposure: No data available
Notes to Physician: Humanized 5c8 is the antibody to
the CD40 ligand, a protein transiently expressed on the
surface of activated T cells. Its activity is related
to blocking the interaction of T cells and B cells
leading to decreased antibody production. Doses to
humans between 0.3 mg/kg and 10 mg/kg have been
proposed for initial clinical trials.
Section 5. Fire Fighting Measures
Flash Point: No data available
Flammable Limits:No data available
Extinguishing Media: Use water spray, CO2, ABC Dry Chemical, or Foam.
Special Fire Fighting Materials: No special procedures.
Unusual Fire and Explosion Hazards: No data available.
Section 6. Accidental Release Measures
No data available. Humanized 5c8 is not a hazardous material as defined
by US EPA.
Section 7. Handling and Storage
No special safety procedures are required. For product safety and
efficacy store bulk intermediate at -70 °C ±10 °C, and final product at
-70 °C ± 10 °C.
Section 8. Exposure Control / Personal Protection
CAUTION: THE CHEMICAL, PHYSICAL, AND TOXICOLOGICAL PROPERTIES OF
Humanized 5c8 HAVE NOT BEEN THOROUGHLY INVESTIGATED. EXERCISE CARE TO
PREVENT CONTACT OR EXPOSURE.
Perform work in a chemical fume hood or Type llB Biological Safety Cabinet
whenever possible.
Follow procedures to minimize the formation of aerosols, the potential for
direct skin or mucous membrane contact, or the potential for exposure by
inhalation or ingestion.
Use personal protective equipment such as lab coat, gloves, safety glasses
or goggles. Wash hands immediately upon removing gloves.
Section 9. Physical and Chemical Properties
Molecular Formula:
Molecular Weight: Approximately 150 kilodaltons
Appearance/Odor: Colorless solution
Solubilities: Water, sodium phosphate/sodium chloride buffer
Boiling Point: No data available
Melting Point: No data available
Vapor Pressure (mm HG): No data available
Vapor Density (Air = 1): No data available
Specific Gravity (H(2)0 = 1): No data available
pH: 7.2
Section 10. Stability and Reactivity
Stability: Humanized 5c8 is Stable
Hazardous Polymerization: No data available
Incompatible Materials: No data available
Conditions to Avoid: No data available
Hazard Decomposition Products: No data available
Section 11. Toxicology Information
CAUTION: The chemical, physical, and toxicological properties of this
product have not been thoroughly investigated. Clinical trials are under
way. Exercise care to prevent contact or exposure.
Humanized 5c8 (BG9588) has been administered intravenously to cynomolgus
monkeys at single doses up to 100 mg/kg and repeat doses of 50 mg/kg
weekly for 6 months. No clinical effects (hematology and clinical
chemistry) were observed for the duration of the treatment. Following a
one month treatment perod at doses up to 25 mg/kg, no signs of latent
toxicity or infection were noted during a 7 month post-dose observation
period.
BG9588 administration did not affect total immunoglobulin (Ig) levels or
Ig isotypes following one month of dosing. Antibody responses to
co-administered soluble protein antigens were reduced in a dose-dependent
manner, and these effects were reversible following clearance of BG9588
during a 7 month post-dose recovery period.
Histopathologic evaluations revealed dose-dependent effects hypoplasia (a
condition of decreased or arrested growth of an organ or tissue) in spleen
and lymph nodes. No other treatment-related histopathologic changes were
observed. Recovery from BG9588 treatment after the 7 month post-dose
observation period occurred as no histopathologic changes were noted at
any dose.
Section 12. Ecological Information
No data available
Section 13. Disposal Considerations
Humanized 5c8 is not a regulated hazardous material. It is water soluble
and may be disposed of as aqueous waste in accordance with state and local
regulatory requirements.
Section 14. Transport Information
DOT Proper Shipping Name: n/a
Hazard Class: n/a
ID #: n/a
Section 15. Regulatory Information
No data available
Section 16. Other Information
MSDS Created: 1-Mar-96
Revised: 31-Mar-97
Prepared By: Susan B. Lee, CIH
Manager, Environmental Health and Safety
DISCLAIMER: The above mentioned data are based on Biogen's best present
knowledge of this product. Biogen cannot guarantee completeness or
accuracy of the information contained herein, and disclaims all liability
for incompleteness or inaccuracy of the information and for any claims of
damages arising from handling or use of this product.