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Foetal Bovine Serum Triple 0.1 µm sterile filtered

Manufactured in Australia

Lot No.: 18050719FBS Product Code(s): S-FBS-AU-015, S-FBS-AU-011

Origin: Australia Date of Manufacture: 05/2019

Expiry Date: 05/2024 Storage: < - 15oC

Certificate of Analysis

Physical and Chemical Analysis

Test Method Specifications Results

Identity Internally Validated Bovine Bovine

Appearance Visual Clear yellow-amber Clear yellow-amber

Specific Gravity Mass Balance > 1.01 g/ml 1.018 g/ml

pH Electronic pH Meter 6.8 – 8.2 7.21

Osmolality Osmometer 280 – 340 mOsm/kg 318 mOsm/kg

Endotoxin LAL Kinetic < 1.0 EU/ml < 0.25 EU/ml

Free Hemoglobin Colorimetric < 25 mg/dl 3.49 mg/dl

Protein Profile

Test Method Specifications Results

Total Protein IDEXX Catalyst One 3.0 – 4.5 g/dl 3.7 g/dl

Albumin IDEXX Catalyst One 1.4 – 3.4 g/dl 1.9 g/dl

Globulin IDEXX Catalyst One 0.4 – 2.4 g/dl 1.8 g/dl

IgG ELISA < 300 µg/ml 122.32 µg/ml

Sterility Testing

Test Method Specifications Results

Aerobic Bacteria Internally Validated Not detected Not detected

Anaerobic Bacteria Internally Validated Not detected Not detected

Fungi (Yeast & Mold) Internally Validated Not detected Not detected

Mycoplasma Internally Validated Not detected Not detected

Virus Testing

Test Specifications Results

BVDV Not detected Not detected

Bovine Herpesvirus (BHV-1) Not detected Not detected

Parainfluenza Virus 3 (PI-3) Not detected Not detected

CPE (IBR) Not detected Not detected

Bovine Parvovirus Not detected Not detected

Bovine Adeno Virus 3 Not detected Not detected

Bovine Adeno Virus 5 Not detected Not detected

Bovine Respiratory Syncytial Virus (BRSV) Not detected Not detected

Reo Virus Not detected Not detected

Rabies Virus Not detected Not detected

Bluetongue (BTV) Not detected Not detected

Bovine Leukemia Virus (BLV) Not detected Not detected

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Foetal Bovine Serum Triple 0.1 µm sterile filtered Manufactured in Australia

Lot No.: 18050719FBS Product Code(s): S-FBS-AU-015, S-FBS-AU-011

Origin: Australia Date of Manufacture: 05/2019

Expiry Date: 05/2024 Storage: < - 15oC

Certificate of Analysis

Antibody Testing

Test Method Specifications Results

BVDV-1 Detection of Antibodies (ELISA) Record Not detected

BVDV-2 Detection of Antibodies (ELISA) Record Not detected

BHV-1 Detection of Antibodies (ELISA) Record Not detected

PI-3 Detection of Antibodies (ELISA) Record Not detected

Antibiotics Testing

Test Method Specifications Results

Tetracycline IDEXX Snap Test Record Not detected

Oxytetracycline IDEXX Snap Test Record Not detected

Chlortetracycline IDEXX Snap Test Record Not detected

Biochemistry

Test Method Specifications Results

Aspartate Aminotransferase (AST) IDEXX Catalyst One Record 39 U/L

Alanine Aminotransferase (ALT) IDEXX Catalyst One Record 21 U/L

Lactate Dehydrogenase (LDH) IDEXX Catalyst One Record 1587 U/L

Alkaline Phosphatase (ALKP) IDEXX Catalyst One Record 154 U/L

Gamma-Glutamyl Transferase (GGT) IDEXX Catalyst One Record 6 U/L

Cholesterol (CHOL) IDEXX Catalyst One Record 0.54 mmol/L

Glucose (GLU) IDEXX Catalyst One Record 4.9 mmol/L

Urea (BUN) IDEXX Catalyst One Record 4.4 mmol/L

Creatinine (CREA) IDEXX Catalyst One Record 171 µmol/L

Uric Acid (URIC) IDEXX Catalyst One Record 132 µmol/L

Calcium (Ca) IDEXX Catalyst One Record 3.26 mmol/L

Phosphorus (PHOS) IDEXX Catalyst One Record 2.92 mmol/L

Total Bilirubin (TBIL) IDEXX Catalyst One Record 7 µmol/L

Magnesium (Mg) IDEXX Catalyst One Record 1.38 mmol/L

Sodium (Na) IDEXX Catalyst One Record 140 mmol/L

Potassium (K) IDEXX Catalyst One Record >10 mmol/L

Chloride (CL) IDEXX Catalyst One Record 107 mmol/L

Triglyceride (Trig) IDEXX Catalyst One Record 0.68 mmol/L

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Foetal Bovine Serum Triple 0.1 µm sterile filtered Manufactured in Australia

Lot No.: 18050719FBS Product Code(s): S-FBS-AU-015, S-FBS-AU-011

Origin: Australia Date of Manufacture: 05/2019

Expiry Date: 05/2024 Storage: < - 15oC

Certificate of Analysis

Cell-Culture Test

Cell Line Method Specifications Results Results (%) vs. Control

L-929 Morphology Tested vs. Control Serum1 3 vs. 3 n/a

HELA Morphology Tested vs. Control Serum1 3 vs. 3 n/a

MRC-5 Morphology Tested vs. Control Serum1 3- vs. 3- n/a

L-929 Density Tested vs. Control Serum2 3 vs. 3 n/a

HELA Density Tested vs. Control Serum2 3 vs. 3 n/a

MRC-5 Density Tested vs. Control Serum2 3 vs. 3- n/a

L-929 Cell Count Cell count [log10/ml]/dead cells [%] vs. Control > 75%

6.13/4.6 vs. 6.18/0.8 99.2%

HELA Cell Count Cell count [log10/ml]/dead cells [%] vs. Control > 75%

6.04/4.6 vs. 6.14/3.6 98.4%

MRC-5 Cell Count Cell count [log10/ml]/dead cells [%] vs. Control > 75%

5.33/1.2 vs. 5.24/1.5 101.7%

Scoring System (vs. Control Serum):

1 0 dead cells; 1 many cells degenerate and many dead cells; 2 cells partially degenerate and many dead cells; 3 few cells degenerate and few dead cells; 4 w/o pathological findings 2 0 single cells/cell aggregates; 1 < 50% confluency; 2 50 – 90% confluency; 3 confluency; 4 overly confluent

Interpretation of Cell Culture Results:

• The culture performance with the test serum and internal control serum showed a similar cell growth.

• All test cells using the test serum 18050719FBS show summary good growth.

Manufactured at 6 Juniper Way, Bunbury WA 6230, Australia

This document was produced electronically and is valid without a signature.

STORING AND THAWING SERUM

Introduction

Animal serum is an exceptional source of nutrients for cells in culture because it contains proteins, lipids, salts, vitamins, minerals, amino acids and other essential components for growth. When stored and handled properly, the performance characteristics of serum can be maintained for many years. Improperly storing and/or thawing serum can decrease the immediate and long-term stability.

Growth promotion data demonstrates that serum maintains its growth characteristics throughout its shelf life if stored properly.

The table below shows stability data for Foetal Bovine Serum for an eight-year period. To maximize short and long term stability, sera must be correctly stored and handled.

Storage

To effectively preserve the integrity of animal serum, it should be stored frozen and protected from light. The recommended storage temperature is -10 to -40 °C. At temperatures below -40 °C, the bottles may become brittle resulting in an increased risk of breakage.

Multiple thaw/freeze cycles should be avoided as they will accelerate the degradation of serum nutrients and can encourage the formation of insoluble precipitates. For this reason, serum should never be stored in “frost-free” freezers. These types of freezers periodically warm themselves to avoid internal ice deposits and are detrimental to the stability of frozen serum products.

Suggested Thawing Procedure

1. Remove the serum bottles from the freezer and allow them to adjust to room temperature forapproximately 10 minutes. 2. Place each container in a 30 to 37 °C water bath or incubator. Excessive temperatures will degrade heatlabile nutrients. If using a water bath, prevent the bottle caps from being submerged. 3. Gently agitate the bottles every 10 – 15 minutes until the serum is completely thawed.

Precipitates

The technique used to thaw serum is critical to its peak performance. An important part to proper thawing is periodic agitation. If a bottle of serum is not periodically agitated as it thaws, salt and protein gradients will form throughout the liquid portion. Within these gradients are high concentrations of salts, proteins and lipids which can lead to the formation of crystalline or flocculent precipitates. These precipitates are not toxic to cell cultures, but they affect the appearance and consistency of each bottle of serum. Small amounts of precipitates are not uncommon, even in serum that is thawed using the recommended procedure. This is normal and will not affect the products performance. If serum is thawed improperly, a larger amount of cryoprecipitate will form and is often insoluble. Filtering out precipitates is not recommended and could result in the loss of nutrients, such as growth factors, mitogens and other proteins.

Efficient and Effective Usage

After thawing, use the serum promptly. Liquid serum may be stored refrigerated (2 to 8 °C) up to four weeks. To avoid thaw/freeze cycles or long periods of refrigeration, it is recommended that any unused serum be immediately dispensed into small, useful aliquots and refrozen for future use.

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