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CTS™ StemPro™ HSC Expansion Medium (Gibco™)

CTS StemPro HSC Expansion Medium was designed to help meet regulatory compliance requirements for ancillary materials and provides more functional cells for cell therapy applications. This xeno-free, serum-free medium is manufactured in accordance with cGMP for medical devices (ISO13485 guidelines). The phenotypes of the hematopoietic stem cells (HSCs) targeted for expansion are the total CD34+ cell population with an emphasis on enrichment of the CD34+CD90+CD45RA- cell subset. CTS StemPro HSC Expansion Medium can be used to study hematopoietic cells from human mobilized peripheral blood, bone marrow, or cord blood.

CTS StemPro HSC Expansion Medium consists of a liquid basal medium and a frozen supplement that is added to the basal medium at the time of use. Growth factors or cytokines are not included.

Features of CTS StemPro Expansion Medium include:
• Manufactured following cGMP for medical devices and designed to help meet regulatory requirements for ancillary materials used in cell and gene therapy manufacturing
• Superior expansion of total CD34+ cell population and enrichment of CD34+CD90+CD45RA- subset
• Maintenance of in vivo functionality as demonstrated in animal engraftment models

Designed to help meet regulatory requirements
CTS StemPro HSC Expansion Medium is manufactured in accordance with cGMP for medical devices and supported by a drug master file (DMF) and regulatory support file (RSF) to assist in global regulatory filings and approvals. The formulation is serum-free and xeno-free, and USP/EP grade components are preferentially chosen where possible. In addition, each lot undergoes quality control testing to ensure safety and performance for cell and gene therapy applications.

Superior expansion
CD34+ cells and the CD34+CD90+CD45RA- subset are found in low proportions in mobilized peripheral blood, bone marrow, and cord blood. They are important for proper hematopoietic and immune function and are studied in a variety of research areas, including transplantation biology, stem cell biology, and hematopoietic development. CTS StemPro HSC Expansion Medium enables superior expansion of not only the total CD34+ compartment, but also enriches for CD34+CD90+CD45RA- stem cells, providing more cells to work with (see figures below).

Maintenance of functionality
Functionality of expanded HSCs is critical to success in cell and gene therapy applications. The most widely accepted method for functional testing of HSCs is engraftment in mouse models. The theory is that if human cells persist after transplantation into immunodeficient mice, the cells have demonstrated long term repopulation and differentiation capacity, which are both defining factors of stem cells. See the figure below for representative mouse model engraftment data of CD34+ cells expanded in CTS StemPro HSC Expansion Medium.

OneFeed™ Supplement (Gibco™)

OneFeed Supplement is a versatile medium supplement. OneFeed Supplement is a chemically-defined, animal-free, protein-free feed shown to enhance protein production when used in a variety of commercially available medium.

EpiLife™ CF Kit (Gibco™)

A sterile, liquid medium prepared without calcium chloride for the long-term, serum-free culture of human epidermal keratinocytes and human corneal epithelial cells. This basal medium requires the addition of calcium plus an appropriate supplement prior to use. Calcium chloride is provided as a separate component with each bottle of medium. EpiLife greatly extends the in vitro lifespan of human epidermal keratinocytes compared to other serum-free media systems. This basal media is animal origin free and contains essential and non-essential amino acids, vitamins, other organic compounds, trace minerals, and inorganic salts. It does not contain antibiotics, antimycotics, hormones, growth factors, or proteins. EpiLife® medium is HEPES and bicarbonate buffered, and is designed for use in an incubator with an atmosphere of 5% CO2 and 95% air.

CTS™ AIM-V™ Medium, without phenol red, without antibiotics (Gibco™)

CTS AIM-V Medium is the first commercially available serum-free formulation for proliferation and/or manipulation of T cells, dendritic cells, and other primary or immortalized cells. CTS AIM-V Medium is an FDA-cleared class-II medical device that is intended for human ex-vivo tissue and cell culture processing applications and is manufactured in compliance with cGMP. It contains L-glutamine and is formulated without phenol red and without antibiotics. CTS AIM-V Medium can be supplemented with human AB serum or CTS Immune Cell SR and various cytokines or growth factors depending on the application.

• cGMP manufactured in compliance with 21 CFR part 820
• Supports expansion of human peripheral blood T-cells including CAR T cells
• Supports expansion of activated human dendritic cells and other immune cells
• Cleared by FDA for human ex-vivo tissue and cell culture processing applications
• Proven clinical use as an ancillary reagent in Provenge™ (sipuleucel-T), the first therapeutic cancer vaccine approved by the FDA [1]
• Adherence to supplier-related responsibilities of USP <1043>*

Security of supply
CTS AIM-V Medium is a defined serum-free formulation that contains no bovine-derived components at the primary component level. The product can be scaled to meet future clinical and commercial demand. Alternate manufacturing sites are available as further risk mitigation.

CTS quality
Gibco CTS products are manufactured at a site that uses methods and controls that conform to cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing sites are ISO 13485- and ISO 9001–certified. Gibco CTS products follow USP <1043> 'ancillary materials for cell, gene, and tissue-engineered products' within the responsibilities applicable to a supplier.*

Accompanied by documentation to support your regulatory filing
Specific intended-use statements, full documentation traceability, and convenient access to our Drug Master File (DMF) are available.

Immune cell applications
CTS AIM-V Medium is cited in many peer-reviewed journals and used in multiple immune cell clinical applications such as activated dendritic cells. CTS AIM-V Medium supports expansion of T cells, T cell subsets, and virus-specific T cells. CTS AIM-V Medium can also be used to support natural killer cells combined with feeders. Each lot of CTS AIM-V Medium is pre-qualified using Jurkat cells, an immortalized human T lymphocyte line, to help ensure consistent performance.

What you get
CTS AIM-V Medium is available with L-glutamine, but phenol red, gentamicin sulfate, and streptomycin sulfate have been removed to meet global regulatory requirements for ancillary materials used in cell therapy manufacturing. For convenience, CTS AIM-V Medium is available in a 1000-mL bottle for small volume users as well as a 10-L bag for larger volume users interested in closed systems.

*Other aspects of USP <1043> will be the responsibility of the end-user to assess. Thermo Fisher Scientific cannot fulfill USP <1043> in regards to application and therapy-specific aspects (e.g., residual assessment and removal of the AM).

1. Madan RA, Gulley JL. Sipuleucel-T: harbinger of a new age of therapeutics for prostate cancer. Expert Rev Vaccines. 2011 10(2):141-50.

CD OptiCHO™ AGT™ Medium (Gibco™)

CD OptiCHO™ medium is specifically designed to offer high performance and yield with recombinant CHO cells in a chemically defined fed-batch environment. The protein-free, animal origin free formulation is designed to provide consistency and reduces the need to screen for adventitious agents. CD OptiCHO™ medium builds on Gibco® CD CHO’s legacy of consistent cell growth and titers, while offering up to 40% better titer and cell growth over select competitors. Thanks to its low osmolality and advanced CHO CD EfficientFeed™ Liquid Nutrient Supplement Kit feeding options, CD OptiCHO™ medium is capable of gaining 2-5 fold increases in fed-batch productivity over batch culture.

When to Use CD OptiCHO™ Medium
• You are using a transfected CHO cell line other than CHO K1, GS CHO or CHO-S™ cell lines
• Optimization of feeding strategies will be part of your base medium selection testing in an effort to maximize productivity
• Your CHO cell line is “finicky," i.e. hard to grow or adapt

When to Consider Another Gibco® Medium

Consider CD FortiCHO™ medium when:
• The cell line you are using is a transfected CHO K1, GS CHO or CHO-S™ cell line
• Maximum batch culture cell densities and protein titers are needed
• You have time to adapt cells into a new medium in an effort to maximize titers
• Cell health at harvest is a priority for downstream processing

Consider CD CHO medium when:
• Your GS CHO cells are recommended to be grown in CD CHO medium
• Your cells have been successfully cultured in CD CHO medium in the past and your process is nearing a regulatory filing (DMF available)

Consider CD DG44 medium when:
• You use parental DG44 or DXB11 CHO cells (dhfr-)

Liquid Media Formulations
Gibco® AGT™ media are also available in a liquid format that offers the same performance and formulation as the AGT™ media format. Gibco® liquid media are manufactured animal origin-free with the same complete, serum-free, protein-free, chemically-defined formulation and performance as their AGT™ media counterparts.

Design Your Own Media Specific to Your Needs
Whether it’s a bench-level experiment or large scale biomanufacturing process, we offer specialized formats, packaging, and quality levels specific to your needs. With Gibco® cGMP Media Custom Services you can put the manufacturing power and years of technical experience of our R&D and Bioproduction Application Specialists to work for you.

OptiPRO™ SFM (Gibco™)

OptiPRO™ SFM is a serum-free, animal origin-free culture medium designed for growth of several kidney-derived cell lines including MDBK, MDCK, PK-15 and VERO for virus or recombinant protein production. In addition, OptiPRO™ SFM has successfully grown other cell lines, such as Hela, BHK-21 and COS-7. Gibco® OptiPRO™ SFM features:
• Serum-free, animal origin-free, low protein formulation
• Direct adaptation for many popular cell lines

Serum-free, animal origin-free, low protein formulation
Gibco® OptiPRO™ SFM is formulated with a very low protein concentration (< 10 µg/ml), allowing for easier purification of your recombinant protein.

Direct adaptation for many popular cell lines
Gibco® OptiPRO™ SFM has been designed for growth of kidney-derived cell lines such as MDCK, MDBK, VERO and PK-15. In addition, OptiPRO™ SFM has successfully grown other cell lines, such as Hela, BHK-21 and COS-7, allowing you to choose a single medium for multiple cell lines.

Product Use
For Research Use Only. Not for use in diagnostic procedures.

cGMP Manufacturing and Quality System
Gibco® OptiPRO™ SFM is manufactured at a cGMP compliant facility located in Grand Island, New York. The facility is registered with the FDA as a medical device manufacturer and is certified to ISO 13485 standards.

Adenovirus Expression Medium (AEM), for PER.C6™ cells (Gibco™)

Adenovirus Expression Medium (AEM) is recommended for the growth of PER.C6® cells in suspension and for the production of viruses and viral vectors in these cells. It is an animal-origin free cell culture medium without components directly derived from human or animal sources. Each lot of AEM is performance tested for cell growth with PER.C6® cells and AEM has been qualified to produce adenovirus and influenza viruses. It also supports HEK 293 cell growth. Glutamine or GlutaMAX™-I supplementation is required.

StemPro™ hESC SFM (Gibco™)

Developed for human embryonic and human induced pluripotent stem cell culture

StemPro® hESC SFM is a fully defined, serum- and feeder-free medium (SFM) specially formulated for the growth and expansion of human embryonic (hESCs) and human induced pluripotent stem cells (iPSC). StemPro® hESC SFM has been extensively tested and is proven to maintain pluripotency in a growing list of hESC lines including BG01, BG02, BG03, H1, H9, and BG01V. In addition, StemPro® hESC SFM has been used to scale up production of hESCs to over 1 x 1010 cells. StemPro® hESC SFM has been shown to support hESC and iPSC growth for >50 passages without any signs of karyotypic abnormalities, and to maintain the ability of hESCs to differentiate into all three germ line lineages.

StemPro® hESC SFM Components:
StemPro® hESC Supplement
DMEM⁄F-12 with GlutaMAX™ medium
Bovine serum albumin 25% (BSA)
Additional components required for complete medium (need to be purchased separately):
FGF BASIC (full length) REC HU (Cat. no. PHG0261)
2-Mercaptoethanol (Cat. no. 21985-023)

Applications:
Formulated for the growth and expansion of human embryonic and human induced pluripotent stem cells.

CTS™ OpTmizer™ T-Cell Expansion SFM, no phenol red, bag format (Gibco™)

Gibco CTS OpTmizer T-Cell Expansion SFM supports the growth and expansion of human T lymphocytes. It is a complete serum-free, xeno-free medium consisting of CTS OpTmizer T-Cell Expansion Basal Medium and CTS OpTmizer T-Cell Expansion Supplement, which are mixed together prior to use.

CTS OpTmizer T-Cell Expansion SFM is available with and without phenol red. This version of CTS OpTmizer SFM lacks phenol red, and is available in both bottle and bag format.

Features of CTS OpTmizer T-Cell Expansion SFM include:
• Supports high-density T cell culture (>4 x 106 CD3+ T-cells/mL)
• Supports T-cell activation using Dynabeads magnetic beads, soluble antibodies, and stimulatory antibody-presenting cell protocols
• Similar phenotype, function (e.g., cytokine secretion profile), and viability to T-cells cultured with conventional human AB serum-supplemented medium
• Supports a T-cell phenotype similar to human serum-supplemented medium
• Demonstrates enhanced efficacy and persistence of CART-19 cells when grown in medium supplemented with CTS Immune Cell Serum Replacement (ICSR)

Demonstrated functional performance
Cells grown in CTS OpTmizer T-Cell Expansion SFM with or without human serum demonstrate good cytokine production profiles in polyclonally activated T cells. CTS OpTmizer T-Cell Expansion SFM maintains the desired the CD62L+ central memory T-cell phenotype.

GMP manufactured
The primary manufacturing site for CTS OpTmizer T-Cell Expansion SFM is FDA-registered and has an ISO13485-certified quality management system. The methods and controls used for the manufacturing are in conformity with current Good Manufacturing Practices for medical devices, 21 CFR Part 820, of the regulation. Alternate manufacturing sites are available, providing risk mitigation by helping to ensure security of supply.

Versatility
CTS OpTmizer T-Cell Expansion SFM has been widely adopted in clinical T-cell research applications including the culture of CAR T-cells. It works with multiple culture formats, including culture flasks, culture bags, and rocking bioreactor systems. CTS OpTmizer T-Cell Expansion SFM was designed to support expansion of cultured human T-cells without additional serum supplementation. Increased performance is generally observed when supplemented with CTS Immune Cell Serum Replacement.

What you get
CTS OpTmizer T-Cell Expansion SFM includes two components: 1 liter of CTS OpTmizer T-Cell Expansion Basal Medium and 26 mLs of CTS OpTmizer T-Cell Expansion Auxiliary Concentrated Medium, which are mixed together to create the complete medium. Full traceability documentation such as Certificate of Origin and Certificate of Analysis are available.

VP-SFM AGT™ Medium (Gibco™)

VP-SFM AGT™ is a serum free, ultra low protein medium (5 µg/ml) in a new easy-to-use granular format. VP-SFM AGT™ is designed for the growth of VERO cells for virus production. It is also suitable for the growth of COS-7, MDCK, BHK-21 and Hep2 cells and for recombinant protein production.

CTS™ Essential 8™ Medium (Gibco™)

CTS Essential 8 Medium is an animal-origin-free (AOF), feeder-free medium formulated for the growth and expansion of both embryonic and induced human pluripotent stem cells (PSCs). Essential 8 Medium is the most defined PSC medium as described in the original publication by Guokai Chen et al. in the laboratory of James Thomson. CTS Essential 8 Medium enables the transition from bench to clinic through the direct replacement of research-use-only (RUO) Essential 8 Medium.

CTS Essential 8 Medium:
• Reduces the risks associated with animal origin material through an AOF formulation
• Facilitates regulatory filings through cGMP manufacturing and the availability of documentation
• Simplifies the transition from bench to clinic with the same 8-component formulation as RUO Essential 8 Medium, but with AOF components

Reduces risks from animal-origin material
CTS Essential 8 Medium contains no animal- or human-derived components at the primary component level, thereby reducing the risks associated with animal-origin components. It is the only commercially available AOF medium for pluripotent stem cell culture: Competitors’ similar-grade products are only xeno-free, containing human serum albumin (HSA), which brings additional risks in a clinical environment.

Facilitates regulatory filings
Gibco CTS products are manufactured at a site that uses methods and controls that conform with cGMP for medical devices, 21 CFR Part 820. Our FDA-registered manufacturing site is ISO 13485- and ISO 9001-certified. Specific intended-use statements, full documentation traceability, and convenient access to our Drug Master File (DMF) are available for CTS Essential 8 Medium.

Simplifies transition from bench to clinic
Like RUO Essential 8 Medium, CTS Essential 8 Medium contains only the eight essential components needed for stem cell culture, but is AOF. Combined with cGMP manufacturing, this simple, fully-defined formulation improves consistency compared to other media that contain over 20 highly variable ingredients. The close similarity between Essential 8 Medium and CTS Essential 8 Medium enables a smooth transition from one medium to the other.

CTS Essential 8 Medium is commercialized in partnership with Cellular Dynamics International.

Medium 200 (Gibco™)

A sterile, liquid medium for the culture of human large vessel endothelial cells. This basal medium requires the addition of LSGS (S-003-10) or LSGS Kit (S-003-K) prior to use.

CD CHO AGT™ Medium (Gibco™)

CD CHO AGT™ (Advanced Granulation Technology) medium is a protein-free, chemically-defined medium optimized for the growth of Chinese hamster ovary (CHO) cells and expression of recombinant proteins in suspension culture. The AGT™ dry media format is designed to provide increased consistency and productivity across all stages of production from development to commercial manufacturing. CD CHO AGT™ medium contains no proteins or peptide components of animal, plant, or synthetic origin, as well as no undefined lysates or hydrolysates.

When to Use CD CHO Medium
• Your GS CHO cells are recommended to be grown in CD CHO medium
• Your cells have been successfully cultured in CD CHO medium in the past and your process is nearing a regulatory filing (DMF available)

When to Consider Another Gibco® Medium

Consider CD FortiCHO™ medium when:
• The cell line you are using is a transfected CHO K1, GS CHO or CHO-S™ cell line
• Maximum batch culture cell densities and protein titers are needed
• You have time to adapt cells into a new medium in an effort to maximize titers
• Cell health at harvest is a priority for downstream processing

Consider CD OptiCHO™ medium when:
• You are using a transfected CHO cell line other than CHO K1, GS CHO or CHO-S™ cell lines
• Optimization of feeding strategies will be part of your base medium selection testing in an effort to maximize productivity
• Your CHO cell line is “finicky," i.e. hard to grow or adapt

Consider CD DG44 medium when:
• You use parental DG44 or DXB11 CHO cells (dhfr-)

Liquid Media Formulations
Gibco® AGT™ media are also available in a liquid format that offers the same performance and formulation as the AGT™ media format. Gibco® liquid media are manufactured animal origin-free with the same complete, serum-free, protein-free, chemically-defined formulation and performance as their AGT™ media counterparts.

Design Your Own Media Specific to Your Needs
Whether it’s a bench-level experiment or large scale biomanufacturing process, we offer specialized formats, packaging, and quality levels specific to your needs. With Gibco® cGMP Media Custom Services you can put the manufacturing power and years of technical experience of our R&D and Bioproduction Application Specialists to work for you.

StemPro™ Chondrogenesis Differentiation Kit (Gibco™)

The StemPro® Chondrogenesis Differentiation Kit has been developed for the chondrogenic differentiation of mesenchymal stem cells (MSCs) in tissue-culture vessels. The kit contains all reagents required for inducing MSCs to be committed to the chondrogenesis pathway and generate chondrocytes. Using StemPro® Chondrogenesis Differentiation Kit in combination with StemPro® MSC SFM or MesenPRO RS™ Medium provides a standardized culture workflow solution for MSC isolation, expansion, and differentiation into collagen matrix-producing chondrocytes.

LHC-8 Medium (1X), without gentamicin (Gibco™)

LHC serum-free media are the most widely used products for culture of bronchial epithelial cells. This is a supplemented medium. For maximum flexibility and convenience, we also offer LHC basal medium.

Applications:
Engineered specifically for the growth of bronchial epithelial cells such as IB3-1, S9, and C38, BEAS-2B, BZR, BBM, Het-1A, NHBE (normal human bronchial epithelial cells), and BBE (bovine bronchial epithelial cells) for asthma, allergy, lung cancer, cystic fibrosis, pulmonary, and esophageal cancer research without further supplements.

Performance and quality testing:
Performance tested in a growth assay using BEAS-2B cells.

Reference(s):
Pawliczak R., et. al. (2001) J Biol Chem 276, 44613. Zhao Y.L., et. al. (2000) Carcinogenesis 21, 2005. Liu X., et. al. (1998) Am J Physiol 274, L58. Hei T.K., et. al. (1997) Environ Health Perspect 105, 1085. Lechner J.F., and LaVeck, M.A. (1985) J Tissue Cult Methods 9, 43.