HyClone Laboratories, Inc.
 

 

Cosmic Calf Serum, US Origin, EMEA Conforming

Cosmic Calf Serum, US Origin, EMEA/CVMP/743/00 and CPMP/BWP/1793/02 Conforming
SH30533.02 100 mL
SH30533.03 500 mL
SH30533.04 1000 mL

To produce our Cosmic Calf Serum, we start with our high quality Iron- Supplemented Bovine Calf Serum and add growth-promoting factors. The result is a superior bovine calf serum fortified with iron and naturally derived components for increased performance with a broad spectrum of cell types. All components of Cosmic Calf are sourced in the USA and are traceable. Studies have shown Cosmic Calf outperforms Iron-Supplemented Bovine Calf Serum and FBS in several applications. HyClone Cosmic Calf serum is filtered through three sequential 100nm (0.1 µm) pore-size rated filters.

Assays (subject to change without notice): Gamma Globulin (Electrophoresis), Alkaline Phosphatase, Lactate Dehydrogenase, Glutamic Pyruvic Transaminase (SGPT), Glutamic Oxaloacetic Transaminase (SGOT), pH, Total Protein, Albumin, Blood Urea Nitrogen, Creatinine, Total Bilirubin, Sodium, Potassium, Calcium, Chloride, Inorganic Phosphorus, Osmolality, Iron, Total Iron Binding Capacity (TIBC), Percent Iron Saturation, Glucose, and IgG.

Tests for SH30533 Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <10 EU/mL
Hemoglobin (spectophotometric) <10 mg/dl
Sterility Testing (Current USP & EP)
Bacteria & Fungi No Growth
Virus Testing (9 CFR 113.53)
Flourescent Antibody
Bluetongue Not Detected
Bovine Adenovirus Not Detected
Bovine Parvovirus Not Detected
Bovine Respiratory Syncytial Virus Not Detected
Bovine Viral Diarrhea Virus Not Detected
Antibodies Pass
Interference/Comparative Titration No Interference
Quantitation Not Detected
Rabies Not Detected
Reovirus Not Detected
Bovine Leukemia Virus Not Detected
Cytopathogenic Agents - e.g IBR Not Detected
Hemadsorbing Agents - e.g. PI3 Not Detected
Mycoplasma
Large Volume, Direct Culture Not Detected
Hoechst DNA Stain Not Detected
Bovine Viral Diarrhea
Antibodies Not Detected
Interference/Comparative Titration Not Detected
Gamma Irradiation >30 kGy
(>3.0 Mrad)
Post-Irradiation Testing
Antibodies Pass
Interference/Comparative Titration No Interference
Quantitation Not Detected
Certificate of Suitability Included


Cosmic Calf Serum, US Origin, EMEA/CPMP/BWP/1793/02 Conforming
SH30087.02 100 mL
SH30087.03 500 mL
SH30087.04 1000 mL

HyClone recognizes the challenges in changing regulatory filings, so we also offer an option to those serum users who need to meet the human guideline requirements, but prefer to continue using the same products (no changes to the product part number) with the addition of three tests.

These products are ordered using the non-EMEA part numbers and are tested per the information below. Standard serum products that require EMEA/CPMP/ BWP/1793/02 conformance are provided with the standard Certificate of Analysis, in addition to an addendum, which includes the additional testing results. It is the combination of both documents that provide assurance that the product purchased is EMEA/CPMP/ BWP/1793/02 Conforming.

Tests for SH30087 (EMEA/CPMP) Specification
Endotoxin (Limulus Amebocyte Lysate - Gel Clot) <10 EU/mL
Hemoglobin (spectophotometric) <10 mg/dl
Sterility Testing Current USP & EP
Bacteria & Fungi No Growth
Virus Testing (9 CFR 113.53)
Flourescent Antibody
Bluetongue Not Detected
Bovine Adenovirus Not Detected
Bovine Parvovirus Not Detected
Bovine Respiratory Syncytial Virus Not Detected
Bovine Viral Diarrhea Virus Not Detected
Rabies Not Detected
Reovirus Not Detected
Cytopathogenic Agents - e.g IBR Not Detected
Hemadsorbing Agents - e.g. PI3 Not Detected
Mycoplasma
Large Volume, Direct Culture Not Detected
Hoechst DNA Stain Not Detected
Certificate of Suitability Included
Additional Tests Needed to Conform to
EMEA/CPMP/BWP/1793/02
Specification
Sterility Testing (Current EP)
Bacteria & Fungi No Growth
Mycoplasma (per EP)
Large Volume, Direct Culture Not Detected
Hoechst DNA Stain Not Detected
Bovine Viral Diarrhea Virus(pre- & post- irradiation)
Interference/Comparative Titration Not Detected

Products Section Navigation
Fetal Bovine Serum
Specialty FBS
Bovine Calf Serum
  - Defined
  - Defined, Iron Supplemented
  - Bovine Growth Serum(BGS)
  - Cosmic Calf
  - Newborn
  - New Zealand Defined
  - New Zealand Defined Iron Supplemented
  - New Zealand Cosmic Calf
  - New Zealand Newborn
  - New Zealand Newborn Iron Supplemented
  - Defined EMEA Conforming
  - Defined, Iron-Supplemented EMEA Conforming
  - Cosmic Calf EMEA Conforming
  - New Zealand Newborn EMEA Conforming
Fetal Bovine Replacement
Other Serum
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