elitegro-adv. porduct description v1.0 feb2018 · title: microsoft word - elitegro-adv. porduct...

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Cell Culture Supplement EliteGro TM Adv. Cat# EPA500 | EPA050 Cat# EPAGMP500 | EPAGMP050 V1.0 (02/2018) | | EliteGro TM Adv. provides abundant human source growth factors and cytokines and works as effective replacement for FBS (fetal bovine serum) to support cell expansion. EliteGro TM Adv. is animal serumfree, nonxenogeneic cell culture supplement for research or industrial commercial cell growth and proliferation of multiple types of mesenchymal stem cells. Products Information Products Catalog No. Spec EliteGro TM Adv. EPA500 500 ml EliteGro TM Adv. EPA050 50 ml EliteGro TM Adv. GMP Grade EPAGMP500 500 ml EliteGro TM Adv. GMP Grade EPAGMP050 50 ml Products Storage EliteGro TM Adv. products are most stable when stored frozen (20°C or below). Products have 3.5 years shelf life determined from Date of Manufacture, continuously stored frozen (20°C or below) in original bottle. The manufacture date is indicated on the product label. Completed media containing EliteGro TM Adv. can be stored at 2 °C to 8 °C for maximum of 2 weeks. Once EliteGro TM Adv. products are thawed, it is recommended to use in completed medium preparation (e.g. 5 %) immediately, or to divide it into singleuse aliquot and store at 20 °C. NOTE: Avoid repeated freezethaw cycles as it will cause potential decrease in EliteGro TM Adv. performance and an increase in insoluble particles. Applications EliteGro TM Adv. is designed to promote cell growth and replace animal serum (e.g. FBS) in multiple cells culture media. For human exvivo tissue and cell culture processing applications. Suggested Cell Type Bone marrow msenchymal stem cell Adipose tissue derived msenchymal stem cell Umbilical cord derived msenchymal stem cell Other kinds of msenchymal stem cell Other supplies required Typical cell culture basal media. (MSCqualified basal medium is recommended) Culture Medium Preparation Thaw frozen EliteGro TM Adv. products at 37 °C before use. Prepare completed media by adding EliteGro TM Adv. as supplement to 5% (v/v), addition of Heparin is NOT required. Seed MSCs at approximately 3×10 3 ~ 6×10 3 cells/cm 2 (recommended cell concentration). Precipitation in Cell Culture Clotting or insoluble particles may form in thawed EliteGro TM Adv. Experiments have showed that particles have no impact to the performance of the products. It is recommended to centrifuge at 3,400 ×g for 3 to 5 minutes or to filter the liquid with a sterile 40 μm Cell Strainer to remove insoluble particles. If required by user's system, filtering the completed media after adding 5% EliteGro TM Adv. by 0.22 μm filters. NOTE: 0.22 μm filtering is NOT recommended for EliteGro TM Adv 100 % concentrate as it may cause decrease in performance.

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Page 1: EliteGro-Adv. Porduct Description V1.0 Feb2018 · Title: Microsoft Word - EliteGro-Adv. Porduct Description_V1.0_Feb2018.doc Created Date: 4/9/2018 3:50:59 AM

Cell Culture Supplement EliteGroTM-­Adv. Cat# EPA-­500 | EPA-­050 Cat# EPAGMP-­500 | EPAGMP-­050 V1.0 (02/2018)

EliteCell BioMedical Corp. | 206 Archway Drive, Woodway, Texas 76712 | [email protected]

EliteGroTM-­Adv. provides abundant human source growth factors and cytokines and works as effective replacement for FBS (fetal bovine serum) to support cell expansion. EliteGroTM-­Adv. is animal serum-­free, non-­xenogeneic cell culture supplement for research or industrial commercial cell growth and proliferation of multiple types of mesenchymal stem cells.

Products Information

Products Catalog No. Spec

EliteGroTM-­Adv. EPA-­500 500 ml

EliteGroTM-­Adv. EPA-­050 50 ml

EliteGroTM-­Adv. GMP Grade EPAGMP-­500 500 ml

EliteGroTM-­Adv. GMP Grade EPAGMP-­050 50 ml

Products Storage

EliteGroTM-­Adv. products are most stable when stored frozen (-­20°C or below). Products have 3.5 years shelf life determined from Date of Manufacture, continuously stored frozen (-­20°C or below) in original bottle. The manufacture date is indicated on the product label.

Completed media containing EliteGroTM-­Adv. can be stored at 2 °C to 8 °C for maximum of 2 weeks.

Once EliteGroTM-­Adv. products are thawed, it is recommended to use in completed medium preparation (e.g. 5 %) immediately, or to divide it into single-­use aliquot and store at -­20 °C.

NOTE: Avoid repeated freeze-­thaw cycles as it will cause potential decrease in EliteGroTM-­Adv. performance and an increase in insoluble particles.

Applications

EliteGroTM-­Adv. is designed to promote cell growth and replace animal serum (e.g. FBS) in multiple cells culture media. For human ex-­vivo tissue and cell culture processing applications.

Suggested Cell Type

Bone marrow msenchymal stem cell Adipose tissue derived msenchymal stem cell Umbilical cord derived msenchymal stem cell Other kinds of msenchymal stem cell

Other supplies required

• Typical cell culture basal media. (MSC-­qualified basal medium is recommended)

Culture Medium Preparation

Thaw frozen EliteGroTM-­Adv. products at 37 °C before use.

Prepare completed media by adding EliteGroTM-­Adv. as supplement to 5% (v/v), addition of Heparin is NOT required.

Seed MSCs at approximately 3×103 ~ 6×103

cells/cm2 (recommended cell concentration).

Precipitation in Cell Culture

Clotting or insoluble particles may form in thawed EliteGroTM-­Adv. Experiments have showed that particles have no impact to the performance of the products.

It is recommended to centrifuge at 3,400 ×g for 3 to 5 minutes or to filter the liquid with a sterile 40 μm Cell Strainer to remove insoluble particles.

If required by user's system, filtering the completed media after adding 5% EliteGroTM-­Adv. by 0.22 μm filters.

NOTE: 0.22 μm filtering is NOT recommended for EliteGroTM-­Adv 100 % concentrate as it may cause decrease in performance.

Page 2: EliteGro-Adv. Porduct Description V1.0 Feb2018 · Title: Microsoft Word - EliteGro-Adv. Porduct Description_V1.0_Feb2018.doc Created Date: 4/9/2018 3:50:59 AM

Cell Culture Supplement EliteGroTM-­Adv. Cat# EPA-­500 | EPA-­050 Cat# EPAGMP-­500 | EPAGMP-­050 V1.0 (02/2018)

EliteCell BioMedical Corp. | 206 Archway Drive, Woodway, Texas 76712 | [email protected]

Safety Information

• EliteGroTM-­Adv. products are tested for microbial, endotoxin, and mycoplasma. Each lot is human MSC-­qualified.

• EliteGroTM-­Adv. products contain human original materials which are non-­reactive to various infectious disease according to FDA and AABB requirement.

• EliteGroTM-­Adv. are produced manufactured at our facility in a clean room environment which meets ISO 14644 requirement and is 21 CFR Parts 820;; Current Good Manufacturing Practice (cGMP) compliant.

• Handle EliteGroTM-­Adv. products in accordance with bio-­safety practices, wear appropriate protective eyewear, clothing, and gloves.

Availability • Sample aliquots are available for your testing • Lot reservation are available

References

Peak serum: implications of serum supply for cell therapy manufacturing Regen. Med. (2012) 7(1), 7-­13

Shanbhag S, Stavropoulos A, Suliman S, Hervig T, Mustafa K.Efficacy of Humanized Mesenchymal Stem Cell Cultures for Bone Tissue Engineering: A Systematic Review with a Focus on Platelet Derivatives. Tissue Eng Part B Rev. 2017 Dec;;23(6):552-­569.

Hemeda H, Giebel B, Wagner W. Evaluation of human platelet lysate versus fetal bovine serum for culture of mesenchymal stromal cells. Cytotherapy. 2014 Feb;;16(2):170-­80.

Naaijkens BA, Niessen HW, Prins HJ, Krijnen PA, Kokhuis TJ, de Jong N, van Hinsbergh VW, Kamp O, Helder MN, Musters RJ, van Dijk A, Juffermans LJ. Human platelet lysate as a fetal bovine serum substitute improves human adipose-­derived stromal cell culture for future cardiac repair applications. Cell Tissue Res. 2012 Apr;;348(1):119-­30.

Bieback K, Hecker A, Kocaömer A, Lannert H, Schallmoser K, Strunk D, Klüter H. Human alternatives to fetal bovine serum for the expansion of mesenchymal stromal cells from bone marrow. Stem Cells. 2009 Sep;;27(9):2331-­41.

DISCLAIMER: TO THE EXTENT ALLOWED BY LAW, ELITECELL BIOMEDICAL AND/OR ITS AFFILIATE(S) WILL NOT BE LIABLE FOR SPECIAL, INCIDENTAL, INDIRECT, PUNITIVE, MULTIPLE OR CONSEQUENTIAL DAMAGES IN CONNECTION WITH OR ARISING FROM THIS DOCUMENT, INCLUDING YOUR USE OF IT.