In this time of dire need, Sepragen team is doing its part to solve the problem of COVID-19. We are providing equipment on an expedited basis to a company developing a vaccine for COVID- 19.

Enabling Biologics Drug Scale up

Enabling Biologics Drug Scale up

Dairy and Nutrition Application.
Processes for Health Enhancing Human Nutritionals

Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale.

Sepralac®

Sepradebitt®

Sepraflavone®

The Sepralac® Process enables the isolation of high value whey protein isolate, alphalactalbumin, lactoferrin and CGMP for use in infant formulae, performance foods and other functional foods. Commercial plants capable of processing over 100,000 liters of whey per day have been commissioned.

Sepradebitt® process to debitter and de-acify citrus juice and the Sepraflavone® Process to isolate the natural “phyto” estrogen of Isoflavone from soy are currently in commercial evaluations with potential licenses.

The Sepralac Process

The development of the market for special constituents in milk offers some very interesting opportunities to the dairy industry and to the many different industries using such constituents in their formulated products.

These products are unique in their applications. It offers new possibilities in the search for an improved and better lifestyle and for curing illnesses and health problems by using ingredients extracted from natural sources. The Sepralac® process has made it possible to isolate certain proteins from whey in a cost-effective manner, which is easily scalable to the requirements of the market.

A major producer in New Zealand is the first licensee and is already producing products. In Europe the first licensee is a major Irish ingredient producer.

Sepragen offers the technology to a limited number of producers and expects to have seven licensees around the world within the next couple of years.

Applications of Whey Based Ingredients

Ingredient Attribute Application
a -lactalbumin Tryptophan content
Essential amino acids
Branched chain amino acids
Humanized baby food
Nutritional products
Sports drink formulations
Lactoferrin Sequesters iron
Antimicrobial agent in body
Immunostimulating effect
Infant formula
Nutritional bars
Sports & performance products
Medical products
Lactoperoxidase Antibacterial agent in body Shampoo
Toothpaste
Acne preparation
Glycomicropeptides Body weight management
Appetite suppressant
Management of phenylketonuria
Sports performance products
Medical products

The Process

The process for producing WPI, alpha-enriched WPI, beta-enriched WPI, lactoferrin, lactoperoxidase and glycomicropeptides is shown in the figure below:

In order to capture the proteins on the resin, the pH of the whey is adjusted to a low pH. This will give all the proteins a positive charge, which will bind it to the negatively charged SepraPrep-S resin.

The pretreated and pH-adjusted whey is loaded on the column after the column has been equilibrated. Then the column is washed with water and the proteins are eluted by means of patented ‘Opposing Salt and pH’ gradients.

The process fractions are processed in an ultra- and diafiltration plant, where the protein is concentrated to 25-27% total solids, while the permeate containing the buffer salt solution is processed in a reverse osmosis plant, concentrating it to 2-3% solids for re-use.

The protein concentrate is dried in a spray dyer, which can be of the tall-form type using an inlet air temperature of 180°C.

Sepralac® Process Economics

Assumptions

Volume

250,000 liters of whey per day

Whey type

Sweet cheese whey, pre-treated, past., normal comp.

Processing time

24 hours per day, 300 days a year

Products Market Price US D/Kg
Permeate 0.18
Whey Protein Isolate 7.5
a –enriched WPI 15
ß-enriched WPI 9
Lactoferrin 250
Lactoperoxidase 300
Annual Prod. (Kg) Case 1 Case 2 Case 3
WPI 364,500 362,800
a –enriched WPI 145,120
ß-enriched WPI 217,680
Lactoferrin 1,200 1,200
Lactoperoxidase 500 500
Permeate 4,110,000 4,110,000 4,110,000
Annual Prod. (USD) Case 1  Case 2 Case 3
WPI 2,773,750 2,721,000
a–enriched WPI 2,176,800
ß-enriched WPI 1,959,120
Lactoferrin 300,000 300,000
Lactoperoxidase 150,000 150,000
Total 2,773,750 3,171,000 4,585,920
Permeate* 739,800 739,800 739,800
Annual Prod. CostsUSD
Depreciation190,625
Resin costs150,000
Membrane system OP80,000
costs 
Chemicals120,000
Water30,000
Energy110,000
Waste treatment25,000
Cost of whey (.5 c/L)375,000
Labor288,000
Drying costs91,125
Total1,469,750
InvestmentUSD
3* 500 L RFC columns675,000
Tanks, pumps, piping200,000
Automation and valves350,000
Membrane systems300,000
Total1,525,000
Annual Gross Case 1 Case 2 Case 3
Margin, USD Process A Process B Process C
Revenue 2,773,750 3,171,000 4,585,920
Production costs 1,469,750 1,690,210 1,763,700
Gross margin 1,264,000 1,480,790 2,822,220
news
You may also like
Browse All
January 2023
Sepragen ships
In the creation of bio-pharmaceutical drugs, cells are genetically modified to produce some compound shown by research to have a desired effect in a treatment program.
Learn more
December 2022
Sepragen completes installation
Sepragen’s products or tools are used to manufacture over 24 FDA approved drugs including Kogenate®, Alphanate®, Neupogen®, and GammaGrand®* along with a multitude...
Learn more
July 2022
Sepragen presents at the Recovery Conference in Rome
Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale. The Sepralac® Process enables the isolation of Lactoferrin...
Learn more

Enabling Biologics Drug Scale up

Dairy and Nutrition Application.
Processes for Health Enhancing Human Nutritionals

Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale.

Sepralac®

Sepradebitt®

Sepraflavone®

The Sepralac® Process enables the isolation of high value whey protein isolate, alphalactalbumin, lactoferrin and CGMP for use in infant formulae, performance foods and other functional foods. Commercial plants capable of processing over 100,000 liters of whey per day have been commissioned.

Sepradebitt® process to debitter and de-acify citrus juice and the Sepraflavone® Process to isolate the natural “phyto” estrogen of Isoflavone from soy are currently in commercial evaluations with potential licenses.

The Sepralac Process

The development of the market for special constituents in milk offers some very interesting opportunities to the dairy industry and to the many different industries using such constituents in their formulated products.

These products are unique in their applications. It offers new possibilities in the search for an improved and better lifestyle and for curing illnesses and health problems by using ingredients extracted from natural sources. The Sepralac® process has made it possible to isolate certain proteins from whey in a cost-effective manner, which is easily scalable to the requirements of the market.

A major producer in New Zealand is the first licensee and is already producing products. In Europe the first licensee is a major Irish ingredient producer.

Sepragen offers the technology to a limited number of producers and expects to have seven licensees around the world within the next couple of years.

Applications of Whey Based Ingredients

Ingredient Attribute Application
a -lactalbumin Tryptophan content
Essential amino acids
Branched chain amino acids
Humanized baby food
Nutritional products
Sports drink formulations
Lactoferrin Sequesters iron
Antimicrobial agent in body
Immunostimulating effect
Infant formula
Nutritional bars
Sports & performance products
Medical products
Lactoperoxidase Antibacterial agent in body Shampoo
Toothpaste
Acne preparation
Glycomicropeptides Body weight management
Appetite suppressant
Management of phenylketonuria
Sports performance products
Medical products

The Process

The process for producing WPI, alpha-enriched WPI, beta-enriched WPI, lactoferrin, lactoperoxidase and glycomicropeptides is shown in the figure below:

In order to capture the proteins on the resin, the pH of the whey is adjusted to a low pH. This will give all the proteins a positive charge, which will bind it to the negatively charged SepraPrep-S resin.

The pretreated and pH-adjusted whey is loaded on the column after the column has been equilibrated. Then the column is washed with water and the proteins are eluted by means of patented ‘Opposing Salt and pH’ gradients.

The process fractions are processed in an ultra- and diafiltration plant, where the protein is concentrated to 25-27% total solids, while the permeate containing the buffer salt solution is processed in a reverse osmosis plant, concentrating it to 2-3% solids for re-use.

The protein concentrate is dried in a spray dyer, which can be of the tall-form type using an inlet air temperature of 180°C.

Sepralac® Process Economics

Assumptions

Volume

250,000 liters of whey per day

Whey type

Sweet cheese whey, pre-treated, past., normal comp.

Processing time

24 hours per day, 300 days a year

Products Market Price US D/Kg
Permeate 0.18
Whey Protein Isolate 7.5
a –enriched WPI 15
ß-enriched WPI 9
Lactoferrin 250
Lactoperoxidase 300
Annual Prod. (Kg) Case 1 Case 2 Case 3
WPI 364,500 362,800
a –enriched WPI 145,120
ß-enriched WPI 217,680
Lactoferrin 1,200 1,200
Lactoperoxidase 500 500
Permeate 4,110,000 4,110,000 4,110,000
Annual Prod. (USD) Case 1  Case 2 Case 3
WPI 2,773,750 2,721,000
a–enriched WPI 2,176,800
ß-enriched WPI 1,959,120
Lactoferrin 300,000 300,000
Lactoperoxidase 150,000 150,000
Total 2,773,750 3,171,000 4,585,920
Permeate* 739,800 739,800 739,800
Annual Prod. CostsUSD
Depreciation190,625
Resin costs150,000
Membrane system OP80,000
costs 
Chemicals120,000
Water30,000
Energy110,000
Waste treatment25,000
Cost of whey (.5 c/L)375,000
Labor288,000
Drying costs91,125
Total1,469,750
InvestmentUSD
3* 500 L RFC columns675,000
Tanks, pumps, piping200,000
Automation and valves350,000
Membrane systems300,000
Total1,525,000
Annual Gross Case 1 Case 2 Case 3
Margin, USD Process A Process B Process C
Revenue 2,773,750 3,171,000 4,585,920
Production costs 1,469,750 1,690,210 1,763,700
Gross margin 1,264,000 1,480,790 2,822,220
news
You may also like
Browse All
January 2023
Sepragen ships
In the creation of bio-pharmaceutical drugs, cells are genetically modified to produce some compound shown by research to have a desired effect in a treatment program.
Learn more
December 2022
Sepragen completes installation
Sepragen’s products or tools are used to manufacture over 24 FDA approved drugs including Kogenate®, Alphanate®, Neupogen®, and GammaGrand®* along with a multitude...
Learn more
July 2022
Sepragen presents at the Recovery Conference in Rome
Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale. The Sepralac® Process enables the isolation of Lactoferrin...
Learn more

Health Enhancing Human Nutrition

Health Enhancing Human Nutrition

Dairy and Nutrition Application.
Processes for Health Enhancing Human Nutritionals

Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale.

Sepralac®

Sepradebitt®

Sepraflavone®

The Sepralac® Process enables the isolation of high value whey protein isolate, alphalactalbumin, lactoferrin and CGMP for use in infant formulae, performance foods and other functional foods. Commercial plants capable of processing over 100,000 liters of whey per day have been commissioned.

Sepradebitt® process to debitter and de-acify citrus juice and the Sepraflavone® Process to isolate the natural “phyto” estrogen of Isoflavone from soy are currently in commercial evaluations with potential licenses.

The Sepralac Process

The development of the market for special constituents in milk offers some very interesting opportunities to the dairy industry and to the many different industries using such constituents in their formulated products.

These products are unique in their applications. It offers new possibilities in the search for an improved and better lifestyle and for curing illnesses and health problems by using ingredients extracted from natural sources. The Sepralac® process has made it possible to isolate certain proteins from whey in a cost-effective manner, which is easily scalable to the requirements of the market.

>A major producer in New Zealand is the first licensee and is already producing products. In Europe the first licensee is a major Irish ingredient producer.

Sepragen offers the technology to a limited number of producers and expects to have seven licensees around the world within the next couple of years.

Applications of Whey Based Ingredients

Ingredient Attribute Application
a -lactalbumin Tryptophan content
Essential amino acids
Branched chain amino acids
Humanized baby food
Nutritional products
Sports drink formulations
Lactoferrin Sequesters iron
Antimicrobial agent in body
Immunostimulating effect
Infant formula
Nutritional bars
Sports & performance products
Medical products
Lactoperoxidase Antibacterial agent in body Shampoo
Toothpaste
Acne preparation
Glycomicropeptides Body weight management
Appetite suppressant
Management of phenylketonuria
Sports performance products
Medical products

The Process

The process for producing WPI, alpha-enriched WPI, beta-enriched WPI, lactoferrin, lactoperoxidase and glycomicropeptides is shown in the figure below: In order to capture the proteins on the resin, the pH of the whey is adjusted to a low pH. This will give all the proteins a positive charge, which will bind it to the negatively charged SepraPrep-S resin. The pretreated and pH-adjusted whey is loaded on the column after the column has been equilibrated. Then the column is washed with water and the proteins are eluted by means of patented ‘Opposing Salt and pH’ gradients. The process fractions are processed in an ultra- and diafiltration plant, where the protein is concentrated to 25-27% total solids, while the permeate containing the buffer salt solution is processed in a reverse osmosis plant, concentrating it to 2-3% solids for re-use. The protein concentrate is dried in a spray dyer, which can be of the tall-form type using an inlet air temperature of 180°C.

Sepralac® Process Economics

Assumptions

Volume

250,000 liters of whey per day

Whey type

Sweet cheese whey, pre-treated, past., normal comp.

Processing time

24 hours per day, 300 days a year

Products Market Price US D/Kg
Permeate 0.18
Whey Protein Isolate 7.5
a –enriched WPI 15
ß-enriched WPI 9
Lactoferrin 250
Lactoperoxidase 300
Annual Prod. (Kg) Case 1 Case 2 Case 3
WPI 364,500 362,800
a –enriched WPI 145,120
ß-enriched WPI 217,680
Lactoferrin 1,200 1,200
Lactoperoxidase 500 500
Permeate 4,110,000 4,110,000 4,110,000
Annual Prod. (USD) Case 1  Case 2 Case 3
WPI 2,773,750 2,721,000
a–enriched WPI 2,176,800
ß-enriched WPI 1,959,120
Lactoferrin 300,000 300,000
Lactoperoxidase 150,000 150,000
Total 2,773,750 3,171,000 4,585,920
Permeate* 739,800 739,800 739,800
Annual Prod. CostsUSD
Depreciation190,625
Resin costs150,000
Membrane system OP80,000
costs 
Chemicals120,000
Water30,000
Energy110,000
Waste treatment25,000
Cost of whey (.5 c/L)375,000
Labor288,000
Drying costs91,125
Total1,469,750
InvestmentUSD
3* 500 L RFC columns675,000
Tanks, pumps, piping200,000
Automation and valves350,000
Membrane systems300,000
Total1,525,000
Annual Gross Case 1 Case 2 Case 3
Margin, USD Process A Process B Process C
Revenue 2,773,750 3,171,000 4,585,920
Production costs 1,469,750 1,690,210 1,763,700
Gross margin 1,264,000 1,480,790 2,822,220
news
You may also like
Browse All
January 2023
Sepragen ships
In the creation of bio-pharmaceutical drugs, cells are genetically modified to produce some compound shown by research to have a desired effect in a treatment program.
Learn more
December 2022
Sepragen completes installation
Sepragen’s products or tools are used to manufacture over 24 FDA approved drugs including Kogenate®, Alphanate®, Neupogen®, and GammaGrand®* along with a multitude...
Learn more
July 2022
Sepragen presents at the Recovery Conference in Rome
Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale. The Sepralac® Process enables the isolation of Lactoferrin...
Learn more

Health Enhancing Human Nutrition

Dairy and Nutrition Application.
Processes for Health Enhancing Human Nutritionals

Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale.

Sepralac®

Sepradebitt®

Sepraflavone®

The Sepralac® Process enables the isolation of high value whey protein isolate, alphalactalbumin, lactoferrin and CGMP for use in infant formulae, performance foods and other functional foods. Commercial plants capable of processing over 100,000 liters of whey per day have been commissioned.

Sepradebitt® process to debitter and de-acify citrus juice and the Sepraflavone® Process to isolate the natural “phyto” estrogen of Isoflavone from soy are currently in commercial evaluations with potential licenses.

The Sepralac Process

The development of the market for special constituents in milk offers some very interesting opportunities to the dairy industry and to the many different industries using such constituents in their formulated products.

These products are unique in their applications. It offers new possibilities in the search for an improved and better lifestyle and for curing illnesses and health problems by using ingredients extracted from natural sources. The Sepralac® process has made it possible to isolate certain proteins from whey in a cost-effective manner, which is easily scalable to the requirements of the market.

>A major producer in New Zealand is the first licensee and is already producing products. In Europe the first licensee is a major Irish ingredient producer.

Sepragen offers the technology to a limited number of producers and expects to have seven licensees around the world within the next couple of years.

Applications of Whey Based Ingredients

Ingredient Attribute Application
a -lactalbumin Tryptophan content
Essential amino acids
Branched chain amino acids
Humanized baby food
Nutritional products
Sports drink formulations
Lactoferrin Sequesters iron
Antimicrobial agent in body
Immunostimulating effect
Infant formula
Nutritional bars
Sports & performance products
Medical products
Lactoperoxidase Antibacterial agent in body Shampoo
Toothpaste
Acne preparation
Glycomicropeptides Body weight management
Appetite suppressant
Management of phenylketonuria
Sports performance products
Medical products

The Process

The process for producing WPI, alpha-enriched WPI, beta-enriched WPI, lactoferrin, lactoperoxidase and glycomicropeptides is shown in the figure below: In order to capture the proteins on the resin, the pH of the whey is adjusted to a low pH. This will give all the proteins a positive charge, which will bind it to the negatively charged SepraPrep-S resin. The pretreated and pH-adjusted whey is loaded on the column after the column has been equilibrated. Then the column is washed with water and the proteins are eluted by means of patented ‘Opposing Salt and pH’ gradients. The process fractions are processed in an ultra- and diafiltration plant, where the protein is concentrated to 25-27% total solids, while the permeate containing the buffer salt solution is processed in a reverse osmosis plant, concentrating it to 2-3% solids for re-use. The protein concentrate is dried in a spray dyer, which can be of the tall-form type using an inlet air temperature of 180°C.

Sepralac® Process Economics

Assumptions

Volume

250,000 liters of whey per day

Whey type

Sweet cheese whey, pre-treated, past., normal comp.

Processing time

24 hours per day, 300 days a year

Products Market Price US D/Kg
Permeate 0.18
Whey Protein Isolate 7.5
a –enriched WPI 15
ß-enriched WPI 9
Lactoferrin 250
Lactoperoxidase 300
Annual Prod. (Kg) Case 1 Case 2 Case 3
WPI 364,500 362,800
a –enriched WPI 145,120
ß-enriched WPI 217,680
Lactoferrin 1,200 1,200
Lactoperoxidase 500 500
Permeate 4,110,000 4,110,000 4,110,000
Annual Prod. (USD) Case 1  Case 2 Case 3
WPI 2,773,750 2,721,000
a–enriched WPI 2,176,800
ß-enriched WPI 1,959,120
Lactoferrin 300,000 300,000
Lactoperoxidase 150,000 150,000
Total 2,773,750 3,171,000 4,585,920
Permeate* 739,800 739,800 739,800
Annual Prod. CostsUSD
Depreciation190,625
Resin costs150,000
Membrane system OP80,000
costs 
Chemicals120,000
Water30,000
Energy110,000
Waste treatment25,000
Cost of whey (.5 c/L)375,000
Labor288,000
Drying costs91,125
Total1,469,750
InvestmentUSD
3* 500 L RFC columns675,000
Tanks, pumps, piping200,000
Automation and valves350,000
Membrane systems300,000
Total1,525,000
Annual Gross Case 1 Case 2 Case 3
Margin, USD Process A Process B Process C
Revenue 2,773,750 3,171,000 4,585,920
Production costs 1,469,750 1,690,210 1,763,700
Gross margin 1,264,000 1,480,790 2,822,220
news
You may also like
Browse All
January 2023
Sepragen ships
In the creation of bio-pharmaceutical drugs, cells are genetically modified to produce some compound shown by research to have a desired effect in a treatment program.
Learn more
December 2022
Sepragen completes installation
Sepragen’s products or tools are used to manufacture over 24 FDA approved drugs including Kogenate®, Alphanate®, Neupogen®, and GammaGrand®* along with a multitude...
Learn more
July 2022
Sepragen presents at the Recovery Conference in Rome
Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale. The Sepralac® Process enables the isolation of Lactoferrin...
Learn more

Biologics Drug Manufacturing

Biologics Drug Manufacturing

Enabling Biological Drugs Scale Up & Production

Sepragen’s products are used to manufacture over 30+ FDA approved drugs including Kogenate®, Alphanate®, Neupogen®, and GammaGrand®* along with a multitude of other drugs currently in clinical trials. Sepragen’s customers range from manufacturers of recombinant biological protein and peptides, vaccines manufacturers, genetic therapy vectors, monoclonal antibody producers for diagnostic and therapeutic use and enzyme producers. In one instance, over 40,000 liters of human plasma is being treated every 6 hours on 2,800 liters of Sepragen columns to produce tens of kilograms of an injectable protein drug.

Case Study 1: Plasma Separation: 9X Higher Flow

Superflo® Columns can dramatically reduce separation times and costs of both labor and materials. The data below was obtained from a plasma fractionation facility. The study was performed in order to compare the performance of a Superflo®-20L Column with that of a 16L axial flow column. Table 1 shows a comparison of the performance of the two columns. With the Superflo® Column, flow rates increased over 3 fold with a corresponding increase in separation speed from three shifts to one shift without affecting product recovery or purity
RFC installation processing 20,000 liters of human plasma every shift. Courtesy: Baxter
RFC installation processing 20,000 liters of human plasma every shift. Courtesy: Baxter
Scale-up on radial flow columns resulted in 1/3 column size, 1/3 processing time and 1/3 media cost.
Scale-up on radial flow columns resulted in 1/3 column size, 1/3 processing time and 1/3 media cost.

Case study 2: Purification of an Intracellular Bacterial Enzyme

The example below shows the isolation of a recombinant protein. Not only is the processing time decreased dramatically, but the recovery is enhanced due to reduction of on column proteolytic degradation.

Biologic Drug Manufacturing

In the creation of biopharmaceutical drugs, cells are genetically modified to produce some compound to have a desired effect in a treatment program. Essentially the cell becomes a chemical factory secreting a certain compound. The cells are then grown in a manner similar to how beer is produced in vats called “bioreactors”.

These cells typically produce very big macromolecules (ranging in molecular weight from 50,000 to well over 100,000), most are proteins and peptides. This differs from traditional pharmaceuticals which are generally made from much smaller molecules.

The manufacture of biological drugs is a fairly long process, but basically consists of 2 parts:

  1. Growing Cells genetically engineered to secrete a compound and
  2. Isolation/Purification, separating/purifying the compound.

Sepragen’s products and services concentrate on these two manufacturing steps making them faster, scalable and more cost effective and reliable. Our customers thus realize the benefits of reduced cost of development and manufacture as well as faster time to market.

Growing Cells

Cells are the micro factories of biologic compounds that are grown in “bioreactors” which provide the nutrients necessary for the cells to reproduce and secrete the compound of interest. Traditional bioreactors are something like beer vats, in which the cells are suspended in a liquid bath of nutrients. Cells are feeding, multiplying and secreting until the batch reaches a terminal condition and is harvested.

Isolation/Purification

After growing the cells in the bioreactors, the compound (protein, peptide, etc) needs to be separated from all the other things (cells, nutrients, etc) using a series of centrifugation, membrane filtration and chromatography steps. The process is almost like petroleum refining/fractionation, where distillation or temperature is used to separate different compounds from oil, e.g., gasoline, diesel, etc. In biotechnology, it is the biochemical properties of the molecules such as molecular size or molecular charge that are used to affect the separation. Additionally, in this industry the process called isolation, purification or separation is targeted towards recovering the product in a pure state, often suitable for injection.

Separation/purification may start with a centrifugation step to remove the cells because they’re big and the liquid can be forced out. Alternatively, filters with pores small enough to stop the cells, but large enough to allow the compound of interest to flow through (“micro-filters” with pores of a few microns in size) are sometimes used for this step. Next, very fine “Ultra filters” are employed to remove water and concentrate the compound. The product of these filtration steps is a clear soup which includes as one of its components, the concentrated compound of interest.

The concentrated compound is then applied to a chromatography step wherein it is selectively adsorbed relative to all the other components and then released to affect a separation.

In one example for instance, at the beginning of the isolation process, a batch may start out with 20,000-30,000 liters of fluid which is concentrated and purified to produce an output of only a single liter. This one liter could be sufficient to provide the drug to the entire US. A dose may be as small as 100 micro-grams.

news
You may also like
Browse All
January 2023
Sepragen ships
In the creation of bio-pharmaceutical drugs, cells are genetically modified to produce some compound shown by research to have a desired effect in a treatment program.
Learn more
December 2022
Sepragen completes installation
Sepragen’s products or tools are used to manufacture over 24 FDA approved drugs including Kogenate®, Alphanate®, Neupogen®, and GammaGrand®* along with a multitude...
Learn more
July 2022
Sepragen presents at the Recovery Conference in Rome
Sepragen has pioneered the three patented processes for the isolation of high value nutritionals on a commercial scale. The Sepralac® Process enables the isolation of Lactoferrin...
Learn more

Biologics Drug Manufacturing

Enabling Biological Drugs Scale Up & Production

Sepragen’s products are used to manufacture over 30+ FDA approved drugs including Kogenate®, Alphanate®, Neupogen®, and GammaGrand®* along with a multitude of other drugs currently in clinical trials. Sepragen’s customers range from manufacturers of recombinant biological protein and peptides, vaccines manufacturers, genetic therapy vectors, monoclonal antibody producers for diagnostic and therapeutic use and enzyme producers. In one instance, over 40,000 liters of human plasma is being treated every 6 hours on 2,800 liters of Sepragen columns to produce tens of kilograms of an injectable protein drug.

Case Study 1: Plasma Separation: 9X Higher Flow

Superflo® Columns can dramatically reduce separation times and costs of both labor and materials. The data below was obtained from a plasma fractionation facility. The study was performed in order to compare the performance of a Superflo®-20L Column with that of a 16L axial flow column. Table 1 shows a comparison of the performance of the two columns. With the Superflo® Column, flow rates increased over 3 fold with a corresponding increase in separation speed from three shifts to one shift without affecting product recovery or purity
RFC installation processing 20,000 liters of human plasma every shift. Courtesy: Baxter
RFC installation processing 20,000 liters of human plasma every shift. Courtesy: Baxter
Scale-up on radial flow columns resulted in 1/3 column size, 1/3 processing time and 1/3 media cost.
Scale-up on radial flow columns resulted in 1/3 column size, 1/3 processing time and 1/3 media cost.

Case study 2: Purification of an Intracellular Bacterial Enzyme

The example below shows the isolation of a recombinant protein. Not only is the processing time decreased dramatically, but the recovery is enhanced due to reduction of on column proteolytic degradation.

Biologic Drug Manufacturing

In the creation of biopharmaceutical drugs, cells are genetically modified to produce some compound to have a desired effect in a treatment program. Essentially the cell becomes a chemical factory secreting a certain compound. The cells are then grown in a manner similar to how beer is produced in vats called “bioreactors”.

These cells typically produce very big macromolecules (ranging in molecular weight from 50,000 to well over 100,000), most are proteins and peptides. This differs from traditional pharmaceuticals which are generally made from much smaller molecules.

The manufacture of biological drugs is a fairly long process, but basically consists of 2 parts:

  1. Growing Cells genetically engineered to secrete a compound and
  2. Isolation/Purification, separating/purifying the compound.

Sepragen’s products and services concentrate on these two manufacturing steps making them faster, scalable and more cost effective and reliable. Our customers thus realize the benefits of reduced cost of development and manufacture as well as faster time to market.

Growing Cells

Cells are the micro factories of biologic compounds that are grown in “bioreactors” which provide the nutrients necessary for the cells to reproduce and secrete the compound of interest. Traditional bioreactors are something like beer vats, in which the cells are suspended in a liquid bath of nutrients. Cells are feeding, multiplying and secreting until the batch reaches a terminal condition and is harvested.

Isolation/Purification

After growing the cells in the bioreactors, the compound (protein, peptide, etc) needs to be separated from all the other things (cells, nutrients, etc) using a series of centrifugation, membrane filtration and chromatography steps. The process is almost like petroleum refining/fractionation, where distillation or temperature is used to separate different compounds from oil, e.g., gasoline, diesel, etc. In biotechnology, it is the biochemical properties of the molecules such as molecular size or molecular charge that are used to affect the separation. Additionally, in this industry the process called isolation, purification or separation is targeted towards recovering the product in a pure state, often suitable for injection.

Separation/purification may start with a centrifugation step to remove the cells because they’re big and the liquid can be forced out. Alternatively, filters with pores small enough to stop the cells, but large enough to allow the compound of interest to flow through (“micro-filters” with pores of a few microns in size) are sometimes used for this step. Next, very fine “Ultra filters” are employed to remove water and concentrate the compound. The product of these filtration steps is a clear soup which includes as one of its components, the concentrated compound of interest.

The concentrated compound is then applied to a chromatography step wherein it is selectively adsorbed relative to all the other components and then released to affect a separation.

In one example for instance, at the beginning of the isolation process, a batch may start out with 20,000-30,000 liters of fluid which is concentrated and purified to produce an output of only a single liter. This one liter could be sufficient to provide the drug to the entire US. A dose may be as small as 100 micro-grams.

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