INNOVATIVE NATURAL INGREDIENTS ADAPTED TO YOUR NEEDS

INNOVATIVE NATURAL INGREDIENTS ADAPTED TO YOUR NEEDS Passion for INNOVATION Passion for LIFE Innovation Manufacturing Quality INNOVATIVE NATURAL ...
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INNOVATIVE NATURAL INGREDIENTS ADAPTED TO YOUR NEEDS

Passion for INNOVATION Passion for LIFE Innovation

Manufacturing

Quality

INNOVATIVE NATURAL INGREDIENTS ADAPTED TO YOUR NEEDS

Health benefits of probiotics

Breast milk

Billions of bacteria coexist in the human gut belonging to more than 400 different species, which constitute the intestinal microbiota. These bacteria perform crucial nutritional and metabolic functions, as well as defending the organism against infections.

Breast milk is the gold standard of infant nutrition since it not only covers the baby’s nutritional needs but also protects it from infections and diseases. The importance of breast milk in the development of intestinal flora, the modulation of the immune system and the prevention of infections in newborns is a well documented fact.

Probiotics are live bacteria that provide beneficial effects to the body, balancing the intestinal microbiota.

The presence of bacterial flora in breast milk had never been investigated as it had always been considered a bacteria-free fluid. Biosearch Life has demonstrated that breast milk is the main source of lactic acid bacteria between the mother and the newborn infant.

The main beneficial effects of probiotics are: ability to reduce diarrhoea and infections, improvement of maturation and functionality of the intestinal barrier, and maturation and modulation of the immune response of the organism. Not all probiotic bacteria are able to exert the same functions, the beneficial properties depend on each strain.

An ‘in house’ screening method was used to select the best probiotic strains from human breast milk of healthy women. The selection process included more than 40 different criteria that considered safety, functionality and gut colonisation as well as technological aspects like the productive return. The result was the selection of several strains naturally found in human breast milk that possessed the best probiotic characteristics:

Lactobacillus gasseri HEREDITUM® Lactobacillus fermentum HEREDITUM® Lactobacillus salivarius HEREDITUM® Bifidobacterium Breve HEREDITUM® These strains were registered under the trademark Hereditum®, and patented (WO/2004/003235) (WO/2008/145756).

Biosearch Life has identified and isolated several novel human milk bacteria with probiotic activity, involved in the protection and well-being of the lactating baby and adults.

INNOVATIVE NATURAL INGREDIENTS ADAPTED TO YOUR NEEDS

Hereditum® is Biosearch Life’s range of premium probiotics isolated from human breast milk and with the ability to be transferred to breast milk after oral intake. Hereditum® human breast milk strains have been selected from hundreds of different strains for their excellent capabilities and probiotic properties, and for their scientifically proven health benefits. The singular origin of Hereditum® makes its range of strains an exceptional candidate for use in infant nutrition, functional foods, health supplements etc.

Scientific guarantee Hereditum® is one of the most widely studied ranges of probiotics. More than 30 publications of Hereditum® published in prestigious scientific journals support its beneficial properties to human health. Hereditum® strains can modulate human immune defences, reducing the risk of infections and alleviating inflammatory responses in several chronic inflammatory diseases, including mastitis.

Their excellent probiotic potential and technological versatility ensures their maximum functionality and performance (e.g. dairy products, fermented or not, sugar rich matrices, infant formulas, supplements, and many others).

LC40

STRAIN L. Fermentum CECT5716

APPLICATION Infant formulas / Food Supplements

Prevention of infections/Mastitis

LC9+K8

Mix L. Gasseri CECT5714 + L. Coryniformis CECT5711

Fermented dairy/Food supplements

Immunity/digestive health

HM6

L. Salivarius CECT5713

Dental care

Oral health

K8

L. Coryniformis CECT5711

Fermented dairy/Food supplements

Immunity

BfM26*

Bifidobacterium Breve CECT7263

Infant Formulas

CLINICAL TRIALS

K8 and K8/Lc9

12% increase in specific antibodies 37% reduction in incidence of an influenza-like illness

Olivares et al

Oral intake of Lactobacillus fermentum CECT5716 enhances the effects of influenza vaccination

Nutrition 23 (2007) 254–260

Immunologic response, infants nutrition, infants infections and mastitis

2

2010

Arroyo et al

Treatment of infectious mastitis during lactation: antibiotic versus oral administration of Lactobacilli isolated from breast milk

Clin Infect Dis 50(12) (2010): 1551-1558

Mastitis

97% decrease for S. aureus 88% with recovery vs 29% in control group 10% with recurrence vs. 31% in control group l0% with discontinuation of breastfeeding vs. 9% in control group

3

2012

Gil-Campos et al

Lactobacillus fermentum CECT 5716 is safe and well tolerated in infants of 1 to 6 months of age: A Randomized Controlled Trial

Pharmacol Res. 2012 Feb; 65 (2): 231-8

Antiinfeccions: infections and nutrition of the infants

Safe 71% reduction of gastrointestinal infections

4

2012

Maldonado et al

The human milk probiotic Lactobacillus fermentum CECT 5716 reduces the incidence of gastrointestinal and respiratory infections in infants. A Randomised Controlled Trial comparing a prebiotic containing follow-on formula vs the same formula plus probiotic

Antiinfeccions: J Pediatr Gastroenterol Nutr. infections and 2012 Jan; 54 (1): 55-61 nutrition of the infant

Safe 46% reduction of gastrointestinal infections 26% reduction of respiratory infections

5

2014

MaldonadoLobón et al

Lactobacillus fermentum CECT5716 reduces the burden of Staphylococcus in milk of women with chest pain during breastfeeding improving symptomatology

Workshop SEPYP 2014, Valencia, Spain

Mastitis

70% reducción S. aureus 78% recuperación

6

2015

MaldonadoLobón et al

Long-term safety of early consumption of Lactobacillus fermentum CECT5716: a three-year follow-up of a randomized controlled trial

Pharmacol Res. 2015 Feb 16. pii: S10436618(15)00014-6

Safety: infant nutrition

Safe

7

2006

Olivares et al

Oral administration of two probiotic strains, Lactobacillus Int J Food Microbiol. Intestinal health: gasseri CECT5714 and Lactobacillus coryniformis CECT5711, 107(2):104-11. K8/Lc9 enhances the intestinal function of healthy adults

Increase 0,6log in lactobacillus Increase 7% water in feces vs. control group (smoother); intestinal transit improves 12%

8

2006

Olivares et al

The consumption of two probiotic strains, Lactobacillus Int. Microbiol. gasseri CECT5714 and Lactobacillus coryniformis 9: 47-52. 2006. CECT5711, boost the immune system of healthy adults

Immunological function: K8/Lc9

23% increase in the proportion of Natural Killer vs control group (innate response

9

2006

Olivares et al

The deprivation of fermented foods in diet causes a fall J. Dairy Res. in innate immune response. Lactic acid bacteria can 21: 1-7. 2006. counteract the immunological effect of this deprivation.

Intestinal microbiota and immunological function: K8/Lc9

Lc9 / K8 counteracted the fall of lactobacillus and the descent of the immune response caused by a diet restricted consumption of fermented foods

10

2007

LaraVilloslada et al

Beneficial effects of consumption of a dairy product containing two probiotic strains, Lactobacillus coryniformis CECT5711 and Lactobacillus gasseri CECT5714 in healthy children

Intestinal health and Immunological function: K8/Lc9

Increased 0.4 log Lactobacillus Increase 33% in faecal and salivary IgA

11

2009

MartínezCañavate et al

A probiotic dairy product containing L. gasseri CECT574 Pediatr Allergy Immunol. 2009; and L. coryniformis CECT5711 induces immunological 20(6): 592-600. changes in children suffering from allergy

Immunological function: K8/Lc9

Increased 0.4 log Lactobacillus 35% increase in the proportion of Natural Killer vs control group (innate response) Faecal IgA levels are doubled

12

2014

Redondo et al

Effect of the consumption of Lactobacillus Coryniformis CECT5711 strain on the immune response of healthy adults

Workshop SEPYP 2014, Valencia, Spain.

Immunological function: K8

Up to 37% increase in the title of specific antibodies to hepatitis A

13

2015

Redondo et al

Intestinal effects after the consumption of L. coryniformis CECT5711 strain by healthy adults

Nutrición Hospitalaria 2015, vol31, S1, pg 127

Intestinal health

Reduction of gastrointestinal discomfort

14

2015

Díaz-Ropero MP. et al.

Lactobacillus salivarius reduces the burden of Streptococcus mutans in saliva

Nutrición Hospitalaria 2015, vol31, S1, pg 141, 142

Oral health

Significantly reduced level of S.mutans was detected in patiens rinsing with probiotic (0,332 lesser, log10 scale)

15

2015

Jose MaldonadoLobón et al.

The human milk strain Bifidobacterium breve CECT7263 is safe in infants from 1 to 12 months and might improve symptoms of infant colic

Nutrición Hospitalaria 2015, vol31, S1, pg 144

Safety: infant nutrition

Colic

* (coming soon)

BfM26 HM6

MAIN EFFECTS

2007

Colic

The Hereditum® range of Probiotics consists of a series of unique strains intended for various applications. The uniqueness of our strains, protected by various patents, lies in the fact that they were originally isolated from human breast milk.

APPLICATIONS

1

FUNCTIONAL EFFECTS

Lc40

BRAND

REF.

Nutr. Hosp. 22(4): 496-502. 2007.

INNOVATIVE NATURAL INGREDIENTS ADAPTED TO YOUR NEEDS

Food applications

Pharmaceutical applications

HEREDITUM INFANT

HEREDITUM IMMUNACTIV Children STRAIN

ORIGIN

FUNCTIONAL EFFECTS

SELLING FORMAT

0,1 mg/g formula

Lc40 (1,3,4,6)

Lactobacillus fermentum CECT5716

Human milk

Immunity/ Defenses

Sachets/capsules Freeze-dried bulk

2E+08cfu/day 3 years)

0,1 mg/g formula

Lc9+K8 (9,10,11)

Lactobacillus gasseri CECT5714 Lactobacillus coryniformis CECT5711

Immunity

Freeze-dried bulk Sachets/sticks

2E+08 cfu/strain/day (>3 years)

8 mg/strain/ sachet

BRAND

STRAIN

FUNCTIONAL EFFECTS

SELLING FORMAT

DAILY DOSE

EXAMPLES OF AMOUNTS PER DOSE*

Lc9+K8 (8,9)

Lactobacillus gasseri CECT5714 Lactobacillus coryniformis CECT5711

Immunity

Freeze-dried bulk Sachets/capsules

K8 (12)

Lactobacillus coryniformis CECT5711

Goat cheese

Immunity

Freeze-dried bulk Sachets/capsules

3E+09 cfu/day (adults)

75 mg/caps (tube)

ORIGIN

FUNCTIONAL EFFECTS

SELLING FORMAT

DAILY DOSE

EXAMPLES OF AMOUNTS PER DOSE*

STRAIN

ORIGIN

FUNCTIONAL EFFECTS

SELLING FORMAT

CFU/DOSE

mg/DOSE

Lc40 (1,3,4,6)

Lactobacillus fermentum CECT5716

Human milk

Immunity/ Defenses

Freeze-dried bulk

1E+07 cfu/g formula

BfM26 (15)

Bifidobacterium breve CECT7263

Human milk

Intestinal comfort

Freeze-dried bulk

1E+07 cfu/g formula

Human milk Goat cheese

Adults HEREDITUM DAIRY BRAND

Lc9+K8 (7-13)

STRAIN

ORIGIN

Lactobacillus gasseri CECT5714

Human milk

Lactobacillus coryniformis CECT5711

Goat cheese

FUNCTIONAL EFFECTS

SELLING FORMAT

DOSE

CFU IN FINAL PRODUCT

Immunity/ Intestinal function

Freeze-dried/ frozen bulk

1 UA to ferment 100l

2E+08cfu/unit of each strain

Biosearch Life can offer Exclusive developments of active ingredients and formulas according to the client’s requirements. Introduction of ingredients to the food & beverages matrix. Pilot Plant (Prototypes) and processes. Development and validation of methods of analysis.

EXAMPLES OF AMOUNTS PER DOSE*

BRAND

BRAND

ORIGIN

Human milk Goat cheese

DAILY DOSE

2E+09 cfu/strain/day 50 mg/caps (tube) (adults)

HEREDITUM DIGESTIPLUS BRAND

STRAIN

Lc9+K8 (7)

Lactobacillus gasseri CECT5714 Lactobacillus coryniformis CECT5711

Human milk Digestive health Goat cheese

Freeze-dried bulk Sachets/capsules

2E+08 cfu/strain/day 8 mg/strain/sachet (>3 years) 2E+09 cfu/strain/day (adults)

50 mg/strain/caps (tube)

HEREDITUM BREASTCARE BRAND

STRAIN

ORIGIN

FUNCTIONAL EFFECTS

SELLING FORMAT

DAILY DOSE

EXAMPLES OF AMOUNTS PER DOSE*

Lc40 (2,5)

Lactobacillus fermentum CECT5716

Human milk

Mastitis

Capsules Freeze-dried bulk

3E+09cfu/day

75 mg/caps (tube)

Stability studies. Regulatory and technical legal advice.

HEREDITUM PARADENS

Product registration and labeling advice. Contract Manufacturing, technology and Know How. Clinical studies for effectiveness and security.

BRAND

STRAIN

ORIGIN

FUNCTIONAL EFFECTS

SELLING FORMAT

DAILY DOSE

MG/ SERVING DOSE

HM6 (14)

Lactobacillus Salivarius CECT5713 Inactivated

Human milk

Oral health

Bulk

1E+09 eq cfu/serving dose

10 mg

*the amounts per dose may vary depending upon the dosage form used.

Competitive advantages of Hereditum® Clinically validated, own safety and efficacy studies. Expertise: successful addition to a wide variety of finished products like infant formula, fermented foods and food supplements. Innovative applications (e.g. mastitis). Stability studies performed in different applications (Food and Food supplements). Guaranteed stability until end of shelf life in the final application. Taste: not affected in any of the tested applications. Protection: All our strains are protected by patents (WO/2004/003235) (WO/2008/145756). Certification ISO 9001:2008* ISO 22000:2005** QPS: All our strains are QPS in Europe. GRAS: LC40 (L fermentum) has Gras status of FDA Kosher and Halal: certification is possible *Design, production and distribution of oils, herbal extracts and probiotics area. **Production and distribution of oils, herbal extracts and probiotics area.

The hereditum® range is patented in the World Intellectual Property Organization (WO/2004/003235).

Leading biotechnology company focused on providing a wide range of high quality products and services worldwide. At Biosearch Life we develop premium quality bioactive ingredients adapted to the current market requirements and trends, which makes us the perfect partner for the development of health supplements, drugs and functional foods. We provide healthy innovative ingredients based on our solid know-how and technology around three product platforms:

HIGHLY PURIFIED AND DEODORIZED FISH OIL

Passion for INNOVATION Passion for LIFE Innovation

Manufacturing

Quality

BIOSEARCH S.A. Camino de Purchil, 66 18004 Granada (Spain) [email protected] Phone: +34-958 240 152 www.biosearchlife.com