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FunctionMAX™ TiterEnhancer Gibco™

FunctionMAX™ TiterEnhancer uses a new technology to combine key nutrients in a highly concentrated (150 g/L), pH-neutral, chemically-defined, AOF (animal origin-free) functional additive that is designed to reinforce existing feeds and amplify the productivity of standard high cell density fed-batch platforms. FunctionMAX™ TiterEnhancer is available in both this liquid format and an AGT™ dry format and is stable for over 1 year. FunctionMAX™ TiterEnhancer offers:

• Up to double prior fed-batch titers
• Highly concentrated ingredients
• Easy to use pH-neutral format
• Specialized delivery of ingredients found in base media—nothing exotic
• Use that is economical

When to Choose FunctionMAX™ TiterEnhancer:

• If you have a drop off in specific productivity late in a high density fed-batch culture, FunctionMAX™ TiterEnhancer may be able to improve your titers
• If you have an extremely low peak cell density fed-batch culture, you may want to consult with PD-Direct® Services for advice on cell adaptation and/or fed-batch optimization
• If you have no drop off in specific productivity late in a high density fed-batch culture and still need higher titers, you may want to consult with PD-Direct® Services for advice on fed-batch optimization

Up to Double Prior Fed-batch Titers
We have demonstrated 35–120% product titer improvements when FunctionMAX™ TiterEnhancer was added on top of existing processes or as a partial feed replacement (Figures 1–3), resulting in a lower total proportion of feed addition. These increases were achieved primarily by maintaining specific productivity throughout each fed-batch process. Improvements were seen immediately and without process optimization. We have also shown that low-volume addition of FunctionMAX™ TiterEnhancer was sufficient to improve titers for several processes using different commercially available media and feeds, with those having higher cell densities seeing the most benefit. This additive is not designed to completely replace other feeding supplements that provide additional ingredients not found in FunctionMAX™ TiterEnhancer.

Highly Concentrated Ingredients
The technology used to deliver this functional additive promises to transform recombinant drug bioprocessing by raising key ingredient concentrations to levels that are out of reach using conventional approaches. A concentration of 150 g/L is achieved with FunctionMAX™ TiterEnhancer (compared to 20–25 g/L for most basal media), and it has been shown to be stable in dry or liquid format for over 1 year.

Easy-to-Use pH-neutral Format
Reconstitution of the AGT™ dry format is surprisingly simple (add water and stir), with all components going into solution. There is no pH adjustment required, and being pH neutral it is safer in handling and use than extreme pH alternatives. As a pH neutral additive, this product will help avoid bioreactor complications often seen with extreme pH supplements. Further, the liquid is very stable—so much so that the liquid format version is made from the same AGT™ dry format material that is also available for purchase. The liquid is provided for small-scale trials and the AGT™ dry format for seamless scale-up in use.

Specialized Delivery of Ingredients Found in Base Media—Nothing Exotic
FunctionMAX™ TiterEnhancer does not introduce new ingredients to your fed-batch process; it simply provides the same key ingredients found in basal media that the cells need late in culture to maintain their productivity. Further, the technology used to combine these ingredients does not introduce any additional ingredients. Nor does it contain any growth factors or undefined components like hydrolysates. A DMF (drug master file) reference can be requested for this product for assurance of regulatory authorities that there are no substances or ingredients in the formulation that might create regulatory concerns.

Economies in Use
FunctionMAX™ TiterEnhancer is designed to deliver highly concentrated and high value addition to your fed-batch process. Consider that it provides 7-fold the ingredient concentration of a basal medium and can provide up to a doubling of titer. Further, in normal use at about 10% of working volume, the actual price per liter of use is similar to that of basal media.

GlycanMod™ G100 Supplement Gibco™

GlycanMod G100 is a chemically defined protein quality supplement, enriched in micronutrients, that is designed to increase mAb galactosylation across multiple cell lines. It is also available as part of the GlycanMod Pak, which includes one of each of our GlycanMod supplements in 100-g, non-GMP sizes.

Each protein quality supplement has a distinct composition which provides more options for achieving your target profile. These supplements are titratable and can be added as needed to achieve the desired galactosylation pattern. GlycanMod supplements offer a solution for your galactosylation needs, helping to get your product to market faster.

The GlycanMod Pak includes:
• GlycanMod G100—enriched in micronutrients
• GlycanMod G125—enriched in carbohydrates and micronutrients
• GlycanMod G150—enriched in trace elements
• GlycanMod G175—enriched in carbohydrates and trace elements

Resurge™ CD2 Supplement, without glucose and L-glutamine Gibco™

Resurge CD2 Supplement, without glucose and L-glutamine, is a chemically defined supplement formulation to complement a variety of base media. This supplement was developed using several host cell lines and in various culture systems, including shaker flasks and bench-scale bioreactors. Resurge CD2 Supplement, without glucose and L-glutamine, was developed for use in CHO mammalian culture systems and can be used either as a media supplement or a culture system feed.

Smooth Muscle Growth Supplement (SMGS) Gibco™

Smooth Muscle Growth Suppelement (SMGS) is a sterile, concentrated (20X) solution intended for use with Medium 231 to culture human smooth muscle cells. Each 25-mL bottle of SMGS contains all of the growth factors, hormones, and tissue extracts necessary for the culture of human smooth muscle cells and is the correct amount of supplement for a 500-mL bottle of basal Medium 231.

When a 500-mL bottle of medium is supplemented with SMGS, the final concentrations of the components in the supplemented medium are:

• Fetal bovine serum: 4.9% v/v
• Human basic fibroblast growth factor: 2 ng/mL
• Human epidermal growth factor: 0.5 ng/mL
• Heparin: 5 ng/mL
• Recombinant human insulin-like growth factor-I: 0.01 µg/mL
• BSA: 0.2 µg/mL

Resurge™ CD4 Supplement, without glucose and L-glutamine Gibco™

Resurge CD4 Supplement, without glucose and L-glutamine, is a chemically defined supplement formulation to complement a variety of base media. This supplement was developed using several host cell lines and in various culture systems, including shaker flasks and bench-scale bioreactors. Resurge CD4 Supplement, without glucose and L-glutamine, was developed for use in CHO mammalian culture systems and can be used either as a media supplement or a culture system feed.

RevitaCell™ Supplement (100X) Gibco™

RevitaCell™ Supplement (100X) has been optimized for use with pluripotent stem cells (PSCs), either as a post-thaw recovery solution to improve cell viability or in combination with Essential 8™ Medium to enhance single cell passaging applications. It can also be used for recovery of primary neurons, traditionally a challenging cell to efficiently recover. The significant improvement seen in these applications is due to the presence of a more specific ROCK inhibitor coupled with molecules containing antioxidant and free radical scavenger properties that minimize the impact of stress on the cells.

• Enabling—provides maximum cell viability when performing single cell passaging
• Rapid cell recovery—high post-thaw cell viability and growth of pluripotent stem cells (passaged as clumps or single cells) and neurons
• Consistent—formulated using animal origin-free and chemically defined materials for quality and confidence

Single cell passaging
Use of the RevitaCellTM Supplement for 18-24 hours post-single cell passaging provides vast improvement in cell survival. Cells are shown to reach passaging confluency within 3-4 days post-seeding.

Higher specificity
Kinase profiling of pro-survival small molecules in RevitaCell™ Supplement shows higher specificity in comparison to traditional ROCK inhibitors (i.e., Y-27632 and Thiazovivin).

Quicker post-thaw recovery
PSCs recovered at 40,000 viable cells/cm2 using media supplemented with RevitaCell™ Supplement for the first 24 hours post-thaw recovery followed by feeding with unsupplemented Essential 8™ Medium will typically reach 80% confluency in <5 days, significantly reducing the average post-thaw recovery time of most cryopreservation solutions. Neurite outgrowth of neurons is also significantly improved using RevitaCell™ Supplement.

CHO CD EfficientFeed™ B Liquid Nutrient Supplement Gibco™

Gibco® CHO CD EfficientFeed™ B liquid nutrient supplement is a product for fed batch addition to the culture of multiple cell lines. CHO CD EfficientFeed™ B liquid nutrient supplement is an animal origin-free, chemically defined formulation that contains no proteins, hydrolysates, or components of incompletely defined composition.

The liquid format is designed for small scale use and experimentation. This product is also available in AGT™ format for large scale manufacturing and ease of use.
• Expect up to 2- to 5-fold increases in productivity
• Avoid issues associated with the use of hydrolysates and other alternatives while gaining superior performance
• Ready for larger scale use with convenient packaging options (10 L and 100 L)

Which EfficientFeed™ Nutrient Supplement to Choose?
Consider the CHO CD Efficient Feed™ Kit when:
• You are using a base medium with less than 6 g/L glucose and no hydrolysate at day 0

Consider CHO CD EfficientFeed™ A supplement when:
• You are currently using CD OptiCHO™ as your base cell growth medium

Consider CHO CD EfficientFeed™ B supplement when:
• You are currently using CD CHO as your base cell growth medium

Consider CD EfficientFeed™ C AGT™ supplement when:
• You want higher productivity in GS CHO and other selected cell lines
• You are currently using CD FortiCHO™ as your base cell growth medium
• You are using a base medium with greater than 6 g/L glucose or a hydrolysate at day 0

Increased Titers
CHO CD EfficientFeed™ supplements have been shown to increase titers 2-5 fold versus batch culture, and are an excellent starting point for process development (Figures 1a & 1b). Furthermore, they outperform competitive alternatives, including less consistent hydrolysates (Figures 2, 3a & 3b).

Simple Scale-Up and Cost Savings
The ability to scale up in a dry format provides ease of handling and storage in manufacturing and other bioprocess settings. With AGT™ (Advanced Granulation Technology™) dry format, it is possible to store and use the product even more easily and safely than traditional dry format products. CHO CD EfficientFeed™ B AGT™ supplement is offered in 10 L and 100 L packaging that allows scale-up from the 1 L liquid supplement as a seamless process, as well as allow for cost savings when purchasing production level volumes.

Comparable Performance to Liquid Supplement
Equally important as the convenience and simplicity of AGT™ (Advanced Granulation Technology™) dry format is the comparable performance to the liquid CHO CD EfficientFeed™ B supplement (Figure 4). Both forms have performed similarly in our testing, and the AGT™ version has been used successfully as a prototype in many processes by multiple companies.

AGT™ Format Ease of Use
CHO CD EfficientFeed™ B AGT™ Nutrient Supplement delivers dry format scale-up convenience as well as simple reconstitution in a single part AGT dry format. For more details, consult the supporting documents provided on the AGT™ format product page.

For research or further manufacturing use. Not for use in diagnostic procedures.

Sodium Pyruvate (100 mM) Gibco™

Sodium pyruvate is commonly added to cell culture media as a carbon source in addition to glucose. Since cells make sodium pyruvate as an intermediate metabolite in the glycolysis pathway, it is not a required supplement for all cell cultures. However, if cells have been grown in medium that is supplemented with sodium pyruvate, we recommend continuing use of the supplement as cell growth may lag without it. Gibco® Sodium Pyruvate (100 mM) is formulated using 11 g per liter of water. The final concentration of sodium pyruvate used in most cell culture media is 1 mM.

Dual-site cGMP Manufacturing and Quality System
Gibco® Sodium Pyruvate Solution 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 an identical Gibco® Sodium Pyruvate Solution product made in our Scotland facility (11360-039). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standard.

GlycanMod™ G125 Supplement Gibco™

GlycanMod G125 is a chemically defined protein quality supplement, enriched in carbohydrates and micronutrients, that is designed to increase mAb galactosylation across multiple cell lines. It is also available as part of the GlycanMod Pak, which includes one of each of our GlycanMod supplements in 100-g, non-GMP sizes.

Each protein quality supplement has a distinct composition which provides more options for achieving your target profile. These supplements are titratable and can be added as needed to achieve the desired galactosylation pattern. GlycanMod supplements offer a solution for your galactosylation needs, helping to get your product to market faster.

The GlycanMod Pak includes:
• GlycanMod G100—enriched in micronutrients
• GlycanMod G125—enriched in carbohydrates and micronutrients
• GlycanMod G150—enriched in trace elements
• GlycanMod G175—enriched in carbohydrates and trace elements

L-Glutamine (200 mM)

Gibco® L-glutamine is an amino acid required for cell culture. L-glutamine participates in the formation of purine and pyrimidine nucleotides, amino sugars, glutathione, L-glutamate and other amino acids, as well as in protein synthesis and glucose production. L-Glutamine, unlike most other amino acids, is not stable in solution. The rate at which this degradation proceeds is a function of time, temperature and pH. We also offer Gibco® GlutaMAX™ supplement as a stable alternative to L-glutamine.

Gibco® L-glutamine 200 mM Solution is a stock solution ready-to-use as a cell culture supplement. The optimal use concentration is dependent upon the cell type and medium used to culture the cells, but generally falls in the range of 2 – 6 mM.

Dual-site cGMP Manufacturing and Quality System
Gibco® L-glutamine 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. For supply chain continuity, we offer an identical Gibco® L-glutamine product made in our Grand Island facility (25030-164). This facility is registered with the FDA as a medical device manufacturer and is certified to the ISO 13485 standards.

CHO CD EfficientFeed™ A AGT™ Nutrient Supplement Gibco™

Gibco® CHO CD EfficientFeed™ A nutrient supplement is an animal origin-free, chemically defined complete feed formulation that provides up to 2-5 fold improvement in titers used in fed batch versus batch culture. It contains no proteins, hydrolysates, or components of incompletely defined composition. CHO CD EfficientFeed™ A AGT™ (Advanced Granulation Technology™) Kit Nutrient Supplement provides all the benefits of CHO CD EfficientFeed™ A liquid supplement in a simpler to scale up and reconstitute 2-part kit that is primarily AGT™ dry format material.

The AGT™ format is designed for large scale manufacturing and ease of use. This product is also available in liquid form for small scale use and experimentation.
• Expect up to 2- to 5-fold increases in productivity
• Avoid issues associated with the use of hydrolysates and other alternatives while gaining superior performance
• Simplify scale-up by leveraging the value of AGT™ simple reconstitution
• Achieve performance comparable to original liquid supplement
• Ready for larger scale use with convenient packaging options (10 L and 100 L)

Which EfficientFeed™ Nutrient Supplement to Choose?
Consider the CHO CD Efficient Feed™ Kit when:
• You are using a base medium with less than 6 g/L glucose and no hydrolysate at day 0

Consider CHO CD EfficientFeed™ A supplement when:
• You are currently using CD OptiCHO™ as your base cell growth medium

Consider CHO CD EfficientFeed™ B supplement when:
• You are currently using CD CHO as your base cell growth medium

Consider CD EfficientFeed™ C AGT™ supplement when:
• You want higher productivity in GS CHO and other selected cell lines
• You are currently using CD FortiCHO™ as your base cell growth medium
• You are using a base medium with greater than 6 g/L glucose or a hydrolysate at day 0

Increased Titers
CHO CD EfficientFeed™ supplements have been shown to increase titers 2-5 fold versus batch culture, and are an excellent starting point for process development (Figures 1a & 1b). Furthermore, they outperform competitive alternatives, including less consistent hydrolysates (Figures 2, 3a, & 3b).

Simple Scale-Up and Cost Savings
The ability to scale up in a dry format provides ease of handling and storage in manufacturing and other bioprocess settings. With AGT™ (Advanced Granulation Technology™) dry format, it is possible to store and use the product even more easily and safely than traditional dry format products. CHO CD EfficientFeed™ A AGT™ supplement is offered in 10 L and 100 L packaging that allows scale-up from the 1 L liquid supplement as a seamless process, as well as allow for cost savings when purchasing production level volumes.

Comparable Performance to Liquid Supplement
Equally important as the convenience and simplicity of AGT™ (Advanced Granulation Technology™) dry format is the comparable performance to the liquid CHO CD EfficientFeed™ A version (Figure 4). Both forms have performed similarly in our testing, and the AGT™ version has been used successfully as a prototype in many processes by multiple companies.

AGT™ Format Ease of Use
CHO CD EfficientFeed™ A AGT™ Kit Nutrient Supplement delivers dry format scale-up convenience as well as simple reconstitution with approximately 1% concentrated solution add back. For more details, consult the supporting documents provided below.

For research or further manufacturing use. Not for use in diagnostic procedures.

Smooth Muscle Differentiation Supplement (SMDS) Gibco™

A sterile, concentrated (100X) solution intended for use with Medium 231 to enhance differentiation of human smooth muscle cells. Each 5 ml bottle of SMDS contains the correct amount of differentiation supplement for a 500 ml bottle of Medium 231. When a 500 ml bottle of medium is supplemented with SMDS, the final concentrations of the components in the supplemented medium are:
• fetal bovine serum, 1% v/v
• heparin, 30 µg/ml

KnockOut™ Serum Replacement - Multi-Species Gibco™

Gibco™ KnockOut™ Serum Replacement – Multi-Species (KnockOut SR – Multi-Species) is a more defined, FBS-free medium supplement that supports the growth of pluripotent stem cells (PSCs) cultured on fibroblast feeder cells. Designed to replace fetal bovine serum (FBS) in existing protocols, this Research Use Only product uses the same KnockOut Serum Replacement formulation that has been trusted by many for almost 20 years. For pre-clinical or clinical applications, please see Cat. No. 10828028.

With KnockOut Serum Replacement – Multi-Species, you can:
• Culture mouse, human, and other mammalian feeder-dependent PSCs with confidence
• Rely on the improved performance of a qualified, FBS-free formulation
• Enjoy the peace of mind of having a more stable price and supply compared to FBS

Culture mammalian PSCs with confidence
The KnockOut SR – Multi-Species formulation has been cited in more than 2000 publications. It has been shown to support feeder-dependent culture of embryonic stem cells (ESCs) and induced pluripotent stem cells (iPSCs) from mouse, human, and other mammalian species. For mouse and human PSCs, it has also been shown to support reprogramming, embryoid body (EB) formation, in vitro differentiation, cryopreservation, ESC derivation, and many other applications.

Rely on improved performance
KnockOut SR – Multi-Species has a more defined formulation compared to FBS, which contains many undefined and variable components. Unlike most FBS products, each lot is tested for its ability to support PSCs. Because of this, culturing mouse and human PSCs with KnockOut SR – Multi-Species leads to less differentiation and more compact colony morphology compared to FBS.

Enjoy the peace of mind of having stable price and supply
KnockOut SR – Multi-Species is not affected by the limited supply and fluctuating prices often seen with FBS. This makes it easier to plan your budget and buy what you need, especially since it is more affordable than most FBS products.

CTS™ Immune Cell SR Gibco™

CTS™ Immune Cell Serum Replacement (SR) is designed to support expansion of in vitro cultured human immune cells such as T cells when added to a basal cell culture media such as CTS™ OpTmizer™ T cell Expansion SFM or CTS™ AIM-V® SFM. CTS™ Immune Cell SR is a defined xeno-free formulation and does not contain bovine or other non-human, animal-derived components.

• Minimizes the supply and safety risks associated with human serum
• Supports expansion of polyclonal T cells (CD3/CD28 bead-activated, OKT3 mAb-activated, virus-specific and tumor-specific T cells)
• Supports T cell phenotype (CD4, CD8, and CD62L) similar to human serum
• Supports expansion of gene-modified CAR T cells (lentiviral transduction)
• Reduces the cost and time associated with qualifying human serum
• Generic enough to use with the base media of your choice

Security of supply and safety
CTS™ Immune Cell SR is a defined xeno-free formulation that contains no bovine or other non-human, animal-derived components at the primary component level. The site 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. Full traceability documentation such as Certificate of Origin, Certificate of Analysis, and Drug Master File are available. The product can be scaled to meet future clinical and commercial demand. Alternate manufacturing sites are available as further risk mitigation.

T cell qualified
CTS™ Immune Cell SR can replace human serum at similar concentrations and achieve similar performance. CTS™ Immune Cell SR supports expansion of polyclonal T cells (CD3/CD28 bead-activated and TILs), T Cell phenotypes (CD4, CD8 and CD62L), and expansion of gene-modified CAR T cells (lentiviral transduction). Every lot is pre-qualified in a functional T cell assay using CTS™ Dynabeads® CD3/CD28-activated primary T cells to ensure consistent performance. This reduces the cost and time associated with human serum lot testing.

Versatility
CTS™ Immune Cell SR can replace human serum at similar concentrations without sacrificing performance in several different base media such as CTS™ OpTmizer™ T Cell Expansion SFM and CTS™ AIM-V® SFM or other commercial media designed for immune cells. Varying dilutions of CTS™ Immune Cell SR should be tested to determine the optimal concentration needed for your cell type and basal media.

What you get
CTS™ Immune Cell SR is available in a 50 mL bottle for small volume users as well as a 500 mL bottle for larger volume users. For added convenience, the product can be freeze-thawed once if smaller aliquots are needed. CTS™ Immune Cell SR can be added to your standard base media at similar concentrations as human serum.

Bovine Pituitary Extract (BPE) Gibco™

The protein concentration of each lot of Bovine Pituitary Extract is determined by the Bradford method. Each vial of BPE contains not less than 25 mg of protein.
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