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IPL-41 Insect Medium (1X) (Gibco™)

Gibco® IPL-41 Insect Medium was originally designed for the growth of Spodeptera frugiperda (Sf9) cells and the expression of recombinant Autographa Californica Nuclear Polyhedrosis Virus (rAcNPV) using the Baculovirus Expression Vector System (BEVS). We offer a variety of Gibco® Media options for a range of insect cell culture applications.

This IPL-41 Insect Medium is modified as follows:

WithWithout
• L-glutamine • Tryptose phosphate broth
• Sodium bicarbonate • Yeastolate

The complete formulation is available. IPL-41 Insect Medium contains unique components required for insect cell culture, including malic acid, fumaric acid, and alpha-ketoglutaric acid.

Product Use
For Research Use Only: Not intended for animal or human diagnostic or therapeutic use.

Dual Site cGMP Manufacturing and Quality System
Gibco® IPL-41 Insect Medium 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. For supply chain continuity, we offer a comparable Gibco® IPL-41 Insect Medium product made in our Scotland facility (11405-057). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard.

Gibco® IPL-41 Insect Medium is commonly supplemented with 10% Fetal Bovine Serum (FBS) before use. IPL-41 Insect Medium requires ambient CO2in order to maintain physiological pH.

TC-100 Insect Medium (Gibco™)

TC 100 Insect Medium was originally designed for the growth of insect cells, including Spodeptera frugiperda (Sf9), and the expression of recombinant Autographa Californica Nuclear Polyhedrosis Virus (rAcNPV) using the Baculovirus Expression Vector System (BEVS). We offer a variety of Gibco® Media options for a range of insect cell culture applications.

This IPL-41 Insect Medium is modified as follows:

With
• L-glutamine
• Tryptose phosphate broth
• Sodium bicarbonate

The complete formulation is available. TC 100 Insect Medium is rich in amino acids and uses tryptose as an additional sugar source.

Product Use
For Research Use Only: Not intended for animal or human diagnostic or therapeutic use.

cGMP Manufacturing and Quality System
Gibco® TC 100 Insect Medium is manufactured at a cGMP compliant facility, located in Paisley, Scotland, UK. The facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard.

Gibco® TC 100 Insect Medium is commonly supplemented with 10% Fetal Bovine Serum (FBS) before use. TC 100 Insect Medium requires ambient CO2 in order to maintain physiological pH.

CTS™ LV-MAX™ Production Medium

CTS LV-MAX Production Medium is a chemically-defined, serum-free, protein-free medium validated for recombinant lentiviral vector production. In addition to supporting high cell density suspension cultures of CTS Viral Production Cells (HEK293F-derived cells), this medium is suitable for preclinical-, clinical-, and commercial-scale transient transfection and lentiviral production when used with the CTS LV-MAX Transfection Kit. CTS LV-MAX Production Medium undergoes stringent QC testing to ensure it is appropriate for the manufacturing of cell and gene therapy applications.

CTS LV-MAX Production Medium may be applicable for other recombinant viral vector production that uses a HEK293 medium.

CTS LV-MAX Production Medium features include:
• Supports CTS Viral Production Cells to achieve densities of over 1 x 107 cells/mL with minimal cell clumping
• Enables high viral titers of up to 1 x 108 TU/mL (unconcentrated lentiviral vectors–GFP)
• Scalable protocol for 96-deep well blocks, flasks, and bioreactors
• Regulatory-compliant medium manufactured in conformity with cGMP for medical devices, 21 CFR, Part 820, and certified to the ISO 13485. Drug Master File and Regulatory Support File available upon request.

CTS LV-MAX Production Medium is formulated with GlutaMAX-I reagent. It is ready to use, with no supplementation required. The chemically defined formulation results in high reproducibility and lot-to-lot reliability. The medium contains no human or animal-origin components. It is not recommended for adherent cell cultures. The formulation of this product is identical to research-grade LV-MAX Production Medium, but CTS LV-MAX Production Medium is validated for clinical and commercial therapeutic applications.

Custom configuration and packaging available upon request.

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.

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 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™ NSC SFM (Gibco™)

Neural Stem Cell Serum Free Medium that provides superior expansion of human NSC's compared to competitive products.

• Supports differentiation capability into astrocytes, oligodendrocytes and neurons
• Supports adherent or spheroid cultures
• Developed for Human Neural Stem Cell Culture

StemPro NSC SFM is a serum-free medium (SFM) specially formulated for the growth and expansion of human neural stem cells (NSCs). StemPro® NSC SFM enables superior human NSC expansion of both adherent and spheroid cultures derived from human embryonic stem cells or fetal tissue compared to existing commercial products. StemPro NSC SFM also maintains the multipotential differentiation capability into astrocytes, oligodendrocytes and neurons. Each lot of StemPro® NSC SFM is cGMP manufactured and qualified using a human NSC proliferation assay.

Keratinocyte Starter Kit (Gibco™)

The Keratinocyte Starter Kit includes Defined Keratinocyte-SFM Medium, growth supplement, and Primary Human Keratinocytes.

Hybridoma-SFM (Gibco™)

Hybridoma-SFM is a serum-free, very low-protein medium specifically developed to support the growth of hybridomas for antibody production. Hybridoma-SFM features:

• Ability to support suspension and stationary hybridomas and myelomas
• Complete, ready-to-use formulation
• Serum-free, very low-protein formulation

Ability to support suspension and stationary hybridomas and myelomas
Suitable for the culture of recombinant myeloma lines as well as traditional hybridomas, Hybridoma-SFM provides high cell densities and IgG production. Cholesterol-dependent cultures such as NS0 require the addition of 250X Cholesterol Lipid Concentrate.

Complete, ready-to-use formulation
Hybridoma-SFM is a complete medium that is ready to use. No supplementation is required.

Serum-free, very low-protein formulation
Hybridoma-SFM is a serum-free, very low-protein formulation, allowing for easier purification of your protein of interest. Hybridoma-SFM contains <20 µg/mL total protein.

Product use
Customers using Gibco® Hybridoma-SFM in a manufacturing process, who have a submission with the FDA, may request a letter of authorization from us to reference our Type II Drug Master File (DMF).

cGMP manufacturing and quality system
Hybridoma-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.

ExpiCHO™ Stable Production AGT Medium (Gibco™)

Gibco ExpiCHO Stable Production Medium (SPM) is specifically designed to simplify your cell line development process into production with minimal effort and a high degree of confidence. This chemically defined, protein-free, animal origin component-free formulation is fully optimized for large-scale fed-batch culture with ExpiCHO-S cells. ExpiCHO SPM supports an easy transition from transient to stable production, provides high titers without the need for additional medium optimization (see figures below), and works well with existing EfficientFeed C+ supplement.

ExpiCHO SPM is part of the ExpiCHO family, an end-to-end solution that empowers you to carry out your entire workflow from transient to stable expression without having to screen or optimize media and feeds.

Hassle-free scale-up
Simplify your process as you transition into stable clones with ExpiCHO SPM—no cell adaptation, no media optimization, no changes in cell doubling time and peak density. ExpiCHO SPM eases the transition using ExpiCHO-S cells and provides optimal performance with less need for fine-tuning from development scientists to get you to the next step faster. This medium supports high titers under standard fed-batch process conditions in conjunction with EfficientFeed C+ supplement. It is available in liquid format or in our AGT dry format (this page) from 10 L through 450 L equivalents with larger sizes available upon request.

ONE Solution
The ExpiCHO family includes products that are engineered to work seamlessly with each other. ExpiCHO SPM is a member of this family and allows expanded support of bioproduction from transient to stable protein expression. Look for ExpiCHO-branded protocols and methods to get optimal performance in the development process.

Members of the ExpiCHO family include:
• ExpiCHO Stable Production Medium (this page)
ExpiCHO Expression Medium
ExpiCHO-S cells
Expifectamine CHO Transfection Kit

The power to streamline transfer to manufacturing
ExpiCHO SPM liquid format and AGT dry format demonstrate comparable cell growth and titer performance (see figure below). Therefore, scale-up and manufacturing using AGT dry format is simplified by knowing that the reconstituted AGT dry format will behave similarly to the liquid format used prior to scale-up. The AGT dry format is easy to reconstitute; just add water and it will automatically adjust pH and osmolality. This can help provide efficiencies in supply chain complexity, reconstitution complexity, and, therefore, overall expense.

When to use ExpiCHO Stable Production Medium:
• When you are using the ExpiCHO-S cell line for transient expression and want to scale up
• After you have completed the stable transfection of ExpiCHO-S cells in ExpiCHO Expression Medium. (Follow our recommended protocol.)
• When you do not have the time to perform medium adaptation or optimization

When NOT to use ExpiCHO Stable Production Medium:
• When you have an existing platform cell-line or feeds and are looking for a broad medium to support a wide variety of cell-lines
• When you need a medium for transfection. For transient and stable transfection, ExpiCHO Expression Medium is recommended.

Support available with ExpiCHO Stable Production Medium:
• A stable cloning protocol designed specifically for the ExpiCHO family of products (must be used for optimal performance)
• Licensing for the ExpiCHO-S cells for development of stable clones. (Contact us at outlicensing@thermofisher.com.)

Design your own media specific to your needs
Whether it’s a bench-level experiment or large-scale bio-manufacturing process, we offer specialized formats, packaging, and quality levels specific to your needs. With Gibco BioProduction Services you can put the manufacturing power and years of technical experience of our R&D and Bioproduction Application Specialists to work for you. Reach out for consultation and/or services in medium, feed, or cell line development.

Liver Digest Medium (Gibco™)

Liver Digest Medium is a collagenase-dispase medium for dissociation of viable liver cells.

CD BHK-21 Production Medium (Gibco™)

Gibco® CD BHK-21 Production Medium is a chemically defined, protein-free cell culture medium. It is designed to support the growth of BHK-21 cells in serum-free suspension culture. This medium is suitable for large-scale manufacturing applications.

CD BHK-21 Production Medium is manufactured as follows:
WithWithout
• L-glutamine• Phenol Red
• Dry powder formatProtein hydrolysates

Gibco® CD BHK-21 Production Medium is the first cell culture medium supporting complete serum-free and protein-free processes for BHK-21 cells. The dry powder format is easy to reconstitute, since it has no hydrolysates in the formulation. Adapting cells from serum-containing media is a rapid and simple procedure. BHK-21 cells can achieve high cell densities and maintain high cell viability in this medium.

Gibco® CD BHK-21 Production Medium is suitable for large-scale suspension culture. Because it does not require supplementation with serum or other undefined components, Gibco® CD BHK-21 Production Medium eliminates the risks associated with serum, while allowing you to achieve consistent virus titers and simplifying downstream purification.

cGMP Manufacturing
Gibco® CD BHK-21 Production Medium 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.

CD Hybridoma Medium (Gibco™)

CD Hybridoma Medium is an animal origin–free, chemically defined, protein-free medium specifically developed for the ability to support the growth of hybridomas for antibody production. Gibco® CD Hybridoma Medium features:

• Ability to support suspension and stationary hybridomas and myelomas
• Formulated without L-glutamine for stability
• Animal origin–free, protein-free, and chemically defined formulation

Ability to support suspension and stationary hybridomas and myelomas
Suitable for the culture of recombinant myeloma lines as well as traditional hybridomas, Gibco® CD Hybridoma Medium provides high cell densities and IgG production. Cholesterol-dependent cultures such as NS0 require the addition of 250X Cholesterol Lipid Concentrate.

Formulated without L-glutamine for stability
Gibco® CD Hybridoma Medium requires the addition of 8 mM L-glutamine or GlutaMAX™ supplement before use. GlutaMAX™ supplement minimizes toxic ammonia build-up and improves cell viability and growth in an easy-to-use format.

Animal origin–free, protein-free, and chemically defined formulation
Gibco® CD Hybridoma Medium is animal origin–free, protein-free, and chemically defined, allowing for easier purification of your protein of interest. Gibco® chemically defined media contain no proteins, hydrolysates, or components of unknown composition.

Product use
Customers using Gibco® CD Hybridoma Medium in a manufacturing process, who have a submission with the FDA, may request from us a letter of authorization to reference our Type II Drug Master File (DMF).

cGMP manufacturing and quality system
Gibco® CD Hybridoma Medium 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.

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.

Cell Medium ACF, without glutamine and NaHCO3 (Gibco™)

Cell Medium ACF, without glutamine and NaHCO3, is a complete medium.