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FunctionMAX™ TiterEnhancer, AGT™ additive (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 a liquid format and this 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.

B-27™ Supplement, minus insulin (Gibco™)

A variation of the most cited neuronal cell culture supplement, B-27 Supplement Minus Insulin is a customized version of the original B-27 Supplement without insulin. B-27 Supplement Minus Insulin is a serum-free supplement designed to support growth of hippocampal and other CNS neurons in applications where the presence of insulin causes interference. B-27 Supplement Minus Insulin is provided as a 50X liquid and is intended for use with Neurobasal Medium or Neurobasal-A Medium.

B-27 Supplement is suitable for use in most neuronal cell applications. For other applications, we provide alternative formulations of B-27 Supplement and Neurobasal media.

For established protocols using B-27 Supplement, access our Gibco Neurobiology Protocol Handbook.

View publications using Gibco neurobiology products at our Gibco CellCite.

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.

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.

Recharge™ Supplement, without glucose and L-glutamine (Gibco™)

Recharge Supplement, without glucose and L-glutamine, is a chemically defined, animal origin-free (AOF) protein-free supplement.

Feed Kit A+, B+, C+ (Gibco™)

The Feed Kit A+, B+, C+ provides three supplements and a supplementation strategy designed to optimize cell growth and/or productivity in CHO cells. The three supplements, EfficientFeed™ A+, EfficientFeed™ B+, and EfficientFeed™ C+ are based on the chemically defined CHO CD EfficientFeed™ A, CHO CD EfficientFeed™ B, and CD EfficientFeed™ C nutrient supplements. Gibco™ EfficientFeed+ AGT™ supplements are dry-format, single-part supplements for fed-batch addition to the culture of multiple cell lines to assist with process development and maximization of bioreactor utilization. Compared to the original EfficientFeed AGT nutrient supplements, EfficientFeed+ supplements have components that are uniquely combined to allow simpler single-part pH-neutral reconstitutions, as well as the ability to super-concentrate the supplements for reduction of product dilution or increased titers with additional feeding. By using the three feed supplements independently or in combination, you can optimize fed-batch protocols for both cell growth and protein yield.

Criteria for supplementation
Specific CHO cell lines and clones react differently to alternative supplementation protocols. Metabolic needs vary and it is essential for optimal growth and/or productivity to determine optimal nutrient supplementation protocols for each cell line or clone. You may find that two or more different feeds are needed. General criteria to consider when designing supplementation protocol experiments are provided in the user manual (downloadable below).

Selecting the feed or combination that may fit best for your process
A chart is provided below to help in the selection of Gibco media and feeds to pair for testing based on cell type. Should you wish to gain additional insight into different methods as well as the field support available to you, consult the user guide or request support through your local Account Manager.

Simplified handling to reduce risk in scale-up
The ability to scale up using AGT dry format provides easier handling and storage in manufacturing and other bioprocess settings. Fewer parts and reconstitution steps mean fewer opportunities for operator error. Further, the ability to store this feed, even when super-concentrated, for the length of a bioreactor run at room temperature in the dark may lessen the chance of contamination by reducing the number of connections to the bioreactor to one or two . Customization of other feeding formulations is possible should that option suit your needs better after trying this kit. You can contact your local Field Application Scientist through your Account Manager to learn more about our customization capabilities.

AlbuMAX™ II Lipid-Rich BSA (Gibco™)

Lipid-rich bovine serum albumin for cell culture. It is chromatographically purified and has an IgG content <=1.0%.

Origin:
New Zealand

CTS™ B-27™ Supplement, XenoFree, minus vitamin A (Gibco™)

CTS B-27 Supplement XenoFree Minus Vitamin A is based on the classic B-27 Supplement formulation and contains no animal-derived components at the primary component level. The absence of vitamin A (retinyl acetate) makes this formulation ideal for the cultivation of neural progenitor and stem cells, either as neurospheres in suspension or in adherent monolayer culture, without inducing differentiation. CTS B-27 Supplement XenoFree Minus Vitamin A reduces the burden in qualifying reagents when transitioning from the research bench to the clinic.

CTS quality
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 sites are ISO 13485– and ISO 9001–certified.

Formulated xeno-free
The preparation contains no animal-derived components at the primary component level.

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.

For other applications, we provide alternative formulations of CTS B-27 supplements and CTS Neurobasal media.

For established protocols using B-27 Supplement, access our Gibco Neurobiology Protocol Handbook.

View publications using Gibco neurobiology products at our Gibco CellCite.

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.

Resurge™ CD3 Supplement, without glucose and L-glutamine (Gibco™)

Resurge CD3 Supplement, without glucose and L-glutamine, is an animal origin-free (AOF) protein-free chemically defined supplement. It can be used in batch and fed batch mode in cell culture processes. All components are chemically defined with known molecular formulae and structures and meet our stringent Animal Origin-Free (AOF) specification.

Resurge CD3 Supplement is formulated without glucose, L-glutamine, and sodium bicarbonate. Due to the balanced nutritional nature of this supplement, rich in amino acids, it has also been used in bacterial applications.

Features:
• Animal origin-free
• Chemically defined
• Protein-free
• Rich in amino acids

Applications of the Resurge CD3 Supplement, without glucose and L-glutamine, include:
• Can be used in batch and fed batch mode in cell culture processes
• Use in bacterial applications

Feed Kit A+ (Gibco™)

The Feed Kit A+ provides two chemically defined supplements, GlygcanTune™ A+ Total Feed and EfficientFeed™ A+ Supplement, along with fed-batch supplementation strategies designed to optimize cell growth and protein production while offering the ability to target and fine tune glycosylation profiles. GlycanTune A+ Total Feed is based on the chemically-defined EfficientFeed A+ Supplement and is specifically designed for fed-batch cultures of multiple cell lines. When used alone or with EfficientFeed+ supplement, this single-part total feeding supplement can shift glycan profiles from heavily G0F to mostly G1F and G2F glycans. GlycanTune A+ Total Feed provides an easy-to-reconstitute, pH-neutral solution that can be super-concentrated for delivery of key nutrients at smaller volumes.

Dialing in a glycan profile
The manual included in the kit (and downloadable below) provides complete protocols for testing GlycanTune A+ Total Feed with EfficientFeed A+ Supplement or another feed to obtain a set of conditions similar to those shown in the charts below. The first chart depicts protocol conditions for establishing a glycan shift pattern and the second shows typical results from a shifting experiment to help you hone in on the best feeding strategy to achieve a desired galactosylation profile.

Simplified handling to reduce risk in scale-up
The ability to scale up using AGT dry format provides easier handling and storage in manufacturing and other bioprocess settings. Fewer parts and reconstitution steps mean fewer opportunities for operator error. Further, the ability to store this feed, even when super-concentrated, for the length of a bioreactor run at room temperature in the dark may lessen the chance of contamination by reducing the number of connections to the bioreactor to one or two. Customization of other feeding formulations is possible should that option suit your needs better after trying this kit. Contact your local Field Application Scientist through your Account Manager to learn more about our customization capabilities.

CTS™ KnockOut™ SR XenoFree Medium (Gibco™)

GIBCO® CTS™ KnockOut™ SR XenoFree Medium, when formulated as a complete medium, enables the growth and expansion of human embryonic stem cells (hESC) and human induced pluripotent stem cells (hiPSC) in a cell culture medium containing only human-derived or human recombinant proteins, to facilitate the transition of hESC and hiPSC research from the bench to the clinic.

The GICTS™ product line enables you to reduce your burden in qualifying reagents during your transition from research applications to clinical applications.

• Defined, xenofree medium for hESC⁄iPSC stem cell culture.
• First-to-market xenofree hESC⁄iPSC product intended for Ex Vivo tissue and cell culture processing applications.

CTS™ KnockOut™ SR XenoFree Medium does not contain bovine or other non-human, animal-derived components. Besides pluripotent stem cell culture expansion and maintenance, CTS™ KnockOut™ SR XenoFree Medium can be used for hESC⁄hiPSC cryopreservation, derivation, and differentiation studies.

GIBCO® CTS™ products are of high quality, and are supplied with harmonized documentation such as Certificates of Analysis, Certificates of Origin, and access to authorization letters for our Drug Master Files, as appropriate.

GlycanMod™ Pak (Gibco™)

The GlycanMod Pak includes protein quality supplements that provide an innovative solution to your protein quality needs. These chemically defined protein quality supplements are designed to increase mAb galactosylation across multiple cell lines. GlycanMod supplements are available as an easy-to-test four-pack, GlycanMod Pak, or as individual products: GlycanMod G100, G125, G150, and G175 supplements.

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. GlycanMod Pak offers one each of our GlycanMod supplements in 100-g, non-GMP sizes.

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

GlycanTune™ C+ Total Feed (Gibco™)

GlycanTune™ C+ Total Feed is an AGT™, or Advanced Granulation Technology™, feeding supplement specifically designed for a fed-batch culture of multiple cell lines. When used, this dry-format, single-part total feeding supplement can shift glycan profiles from heavily G0F to mostly G1F and G2F glycans. The product is an animal origin–free, chemically-defined formulation that contains no proteins, hydrolysates, or components of unknown composition. GlycanTune C+ Total Feed provides an easy-to-reconstitute, pH-neutral solution that can be concentrated from the suggested 87.7 g/L (1X) up to 175.4 g/L (2X). As a result, key nutrients can be delivered in smaller volumes.

Which GlycanTune Total Feed to choose?

Consider GlycanTune C+ Total Feed when:
• You have used Gibco™ EfficientFeed™ C+ (Plus) AGT Supplement in the past and wish to maintain the benefits of simpler reconstitution and super-concentration in delivering key components alongside improved glycan profile
• You are currently using another feed and wish to shift glycan profile more toward G1 and G2
• You are using a cell line or base medium where Dynamis™ Medium may be considered an option

Consider GlycanTune A+ Total Feed when:
• You have used Gibco EfficientFeed A+ (Plus) AGT Supplement in the past and wish to maintain the benefits of simpler reconstitution and super-concentration in delivering key components alongside improved glycan profile
• You are currently using another feed and wish to shift glycan profile more toward G1 and G2
• You are using a cell line or base medium where CD OptiCHO™ Medium may be considered an option

Consider GlycanTune B+ Total Feed when:
• You have used Gibco EfficientFeed B+ (Plus) AGT Supplement in the past and wish to maintain the benefits of simpler reconstitution and super-concentration in delivering key components alongside improved glycan profile
• You are currently using another feed and wish to shift glycan profile more toward G1 and G2
• You are using a cell line or base medium where CD CHO Medium may be considered an option

Dialing in a glycan profile
By following the protocol recommended to test with GlycanTune Total Feed, it is possible to shift the glycan protein expression profiles from primarily G0 to primarily G1 and G2.

Increasing titers
As a complete feed, GlycanTune total feeds have been shown to provide multiple-fold increases in titers at 1X concentration versus batch culture; as such, they are an excellent starting point for process development when a shift in glycan profile is desired. Flexibility to further increase titers is enhanced with the ability to super-concentrate the product by reconstituting with less water to deliver up to 175.4 g/L of fed nutrients (see figure).

Maximizing bioreactor utilization
Have you ever wished you could have more working volume at the start of a bioreactor run to get more protein produced, but needed too much feeding volume space to accomplish your optimal goal? Have you ever thought that room for a little more feeding might get you to a new level of titer from a process and maybe even reduce the number of bioreactor runs that might be needed per year? In either of these cases, it is important to have the flexibility to super-concentrate your feeding supplements so you get less product dilution, more space for an additional feeding, and/or more working volume to start your run (see figure). In fact, you may gain about 20% more bioreactor utilization by exploring the unique ability to super-concentrate this GlycanTune C+ product.

Simplified handling to reduce risk in scale-up
The ability to scale up using AGT dry format provides easier handling and storage in manufacturing and other bioprocess settings. Fewer parts and reconstitution steps mean fewer opportunities for operator error. Further, the ability to store this feed, even when super-concentrated, for the length of a bioreactor run at room temperature in the dark may allow less chance of contamination by reducing the number of connections to the bioreactor to one or two—depending on whether GlycanTune Total Feed can be used alone or after a change from your current feed.

CTS™ RevitaCell™ Supplement (100X)

CTS RevitaCell Supplement (100X) is a cGMP-manufactured, animal origin-free, chemically defined supplement that is used with pluripotent stem cells (PSCs), either as a post-thaw recovery solution to improve cell viability or in combination with CTS Essential 8 Medium to enhance single cell passaging applications. CTS RevitaCell Supplement reduces the burden in qualifying reagents when transitioning from the research bench to the clinic.

CTS RevitaCell Supplement:
• Facilitates regulatory filings through cGMP manufacturing and the availability of documentation
• Simplifies the transition from bench to clinic through the direct replacement of RUO RevitaCell Supplement

Facilitates regulatory filings
CTS RevitaCell Supplement is 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-certified. Full documentation traceability and convenient access to our Drug Master File (DMF) are available for CTS RevitaCell Supplement.

Simplifies transition from bench to clinic
Like the RUO RevitaCell Supplement, the CTS RevitaCell Supplement maximizes cell viability post-single cell passaging and yields high post-thaw cell viability and growth of pluripotent stem cells. Both the RUO and CTS RevitaCell supplements include a ROCK inhibitor that has higher specificity than the traditional inhibitors, coupled with molecules containing antioxidant and free radical scavenger properties that minimize the impact of stress on the cells. With its additional safety testing, including adventitious agents, CTS RevitaCell Supplement enables a smooth transition from RUO RevitaCell Supplement.