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Clinically-Documented Probiotics for Human Health. Brian Peeters Strategic Sales Manager Chr. Hansen A/S. Agenda. Introduction Why Chr. Hansen as Preferred Supplier Basics of Probiotics Market Trends Designing a Probiotic Product for the Military. Chr. Hansen…. Company founded in 1874

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clinically documented probiotics for human health

Clinically-Documented Probiotics for Human Health

Brian Peeters

Strategic Sales Manager

Chr. Hansen A/S

agenda
Agenda

Introduction

Why Chr. Hansen as Preferred Supplier

Basics of Probiotics

Market Trends

Designing a Probiotic Product for the Military

chr hansen
Chr. Hansen…
  • Company founded in 1874
  • Fermenting bacteria cultures for more than 100 years
  • 2,500 employees in 30 countries
  • Turnover of 500M EUR with double-digit organic growth
  • 6% of turnover spent on R&D
    • 225 employees in Research & Development
  • State-of-the-art production facilities
    • GMP pharma & food, Kosher, QC, HACCP,ISO 9002
    • Production facilities on 5 continents
  • Strong partnerships with customers
  • Everyday more than 500 million people consume products containing Chr. Hansen ingredients

Founder Danish Pharmacist Christian D.A. Hansen

…when science matters

chr hansen organizational structure
Chr. Hansen Organizational Structure

Health & Nutrition Division is dedicated solely to Probiotics

Chr. Hansen

Cultures &

Enzymes

Health &

Nutrition

Natural

Colors

agenda7
Agenda

Introduction

Why Chr. Hansen as Preferred Supplier

Basics of Probiotics

Market Trends

Designing a Probiotic Product for the Military

slide8

Why Partner with Chr. Hansen?

  • Documented Efficacy and Safety
    • More than 450 research papers supporting Chr. Hansen probiotic strains
    • More than 80 human clinical studies documenting strain efficacy
    • Strains selected among the 8,700 strain deposits in Chr. Hansen’s cell bank in Denmark
    • Extensive QC programs (cGMP)
    • Been producing and selling probiotics for >20 years
  • Scientific expertise
    • 6% of turnover spent on R&D
    • 225 employees in Research & Development
    • Patented processes and concepts
    • Novel equipment and production technologies
    • Strong research team developing new probiotics strains
slide9

Why Partner with Chr. Hansen?

  • Product Supply
    • Market leader with world’s largest lactic acid bacteria plant
    • Pharmaceutical Production (Pharma cGMP)
    • Global quality and safety policy ensuring high standard in food production (ISO 9001/HACCP)
  • Consumer Friendly
    • Well-established safety
    • GMO-free products
    • “Big 8” Allergen-free products available
  • Internationally & Locally Affiliated
    • ISAPP, IPA, Norfood, PROBDEMO, LABIP
    • Leading probiotic research groups at universities & institutes
agenda10
Agenda

Introduction

Why Chr. Hansen as Preferred Supplier

Basics of Probiotics

Market Trends

Designing a Probiotic Product for the Military

definition of probiotics
Definition of “Probiotics”
  • The World Health Organization (WHO) and the Food and Agriculture Association (FAO) define probiotics as:

“Live microorganisms that when consumed in adequate amounts confer a health benefit on the host.”

introduction to probiotics
Introduction to Probiotics

Probiotics means ”for life” in Latin

Probiotics are live bacteria with health benefits

First scientist to discover health benefits of probiotics was immunologist Dr. Eli Metchnikoff

  • Received Nobel Prize in 1908

10x more bacterial cells in human body (~1014) than there are human tissue cells (~1013)

Gastrointestinal tract is largest immune organ in human body (80% of Immune System is located here)

Probiotics first commercialized via yogurts:

  • Yakult introduced in Japan in 1935
  • Danone’s Activia introduced in France in 1987, U.S. in 2006
strain taxonomy note overview not exhaustive
Strain TaxonomyNote: Overview not exhaustive

Bacterial

group

Bacterial

genus

Bacterial

species

Bacterial

sub-species

Bacterial

strains

Lactid acid

bacteria

Lactobacillus

paracasei

paracasei subsp.

paracasei

CRL-431

Bifidobacterium

acidophilus

paracasei subsp.

tolerans

LC-01

F-19

Enterococcus

fermentum

Weissella

reuteri

Carnobacterium

delbrueckii

Streptococcus

rhamnosus

Lactococcus

plantarum

slide14

Strengthen the immune system

Inhibit adhesion of pathogencells

Modulates cytokine

production

Produce surface-

active substances

Produce

hydrogen peroxide

Inhibit growth

of pathogen cells

Produce

acids

Work as

co-aggregation molecules

Produce bacteriocins

Block the spread of pathogens

Inhibit growth of pathogens

Probiotics – Mechanisms of Action

Probiotic

strain

probiotics mechanisms of action

Strengthen the immune system

Inhibit adhesion of pathogencells

Modulates cytokine

production

Produce surface-

active substances

Produce

hydrogen peroxide

Inhibit growth

of pathogen cells

Produce

acids

Work as

co-aggregation molecules

Produce bacteriocins

Block the spread of pathogens

Inhibit growth of pathogens

Probiotics – Mechanisms of Action

Probiotic

strain

agenda16
Agenda

Introduction

Why Chr. Hansen as Preferred Supplier

Basics of Probiotics

Market Trends

Designing a Probiotic Product for the Military

scientific interest in probiotics has grown significantly since 2000
Scientific interest in probiotics has grown significantly since 2000…

PubMed Articles on Probiotics (#)

and so has the number of probiotic trials
…and so has the number of probiotic trials

Probiotic trials registered on www.clinicaltrials.gov NIH (#)

US trials

Non-US trials

slide19
Increasing interest in probiotics seen in recent yearsDietary supplements: Gone from 16 launches in ‘02 to 75 launches in ‘07

Probiotic product launches globally (#)

669

594

Other

491

Cheese

394

Diet. suppl.

242

150

Fermented

milks

Source: Mintel database; Global launches

increasing number of dietary supplement probiotic product launches in 2007 driven by europe
Increasing number of dietary supplement probiotic product launches in 2007 (driven by Europe)

Probiotic product launches globally; dietary supplements (#)

75

Rest of

World

54

51

Europe

38

31

16

Japan

US

Source: Mintel database; Global launches

~35% average annual growth last 5 years

chr hansen sees market drivers in probiotic supplement market continuing to feed a strong growth
Chr. Hansen sees market drivers in probiotic supplement market continuing to feed a strong growth

General interest in self-medication

Taboo on intestinal issues declining

Probiotic supplements expected to continue double-digit growth

Demographic shift

Trend towards ”natural cure” rather than pharma

Consumer awareness below 50% in most countries

agenda22
Agenda

Introduction

Why Chr. Hansen as Preferred Supplier

Basics of Probiotics

Market Trends

Designing a Probiotic Product for the Military

designing a probiotic product for the military
Designing a Probiotic Product for the Military

1

Indication

2

8

Regulatory /

Claim

Other

Shelf

stability

Strain(s)

Your product

7

3

Potency

Survival

through stomach

Dosage

form

6

4

5

chr hansen offers different indication concepts

Indica-

tion

Chr. Hansen offers different indication concepts

1. Everyday Intestinal Balance

2. Antibiotic Associated Diarrhea

3. Traveler's Diarrhea

4. Children's Diarrhea

5. Immune Boost

6. Atopic Eczema*

7. Bacterial Vaginosis

*Concept supported by fewer clinical studies

chr hansen offers different indication concepts25

Indica-

tion

Chr. Hansen offers different indication concepts

1. Everyday Intestinal Balance

3. Traveler's Diarrhea

5. Immune Boost

*Concept supported by fewer clinical studies

chr hansen offers different indication concepts26

Indica-

tion

Chr. Hansen offers different indication concepts

1. Everyday Intestinal Balance

2. Antibiotic Associated Diarrhea

3. Traveler's Diarrhea

4. Children's Diarrhea

5. Immune Boost

6. Atopic Eczema*

7. Bacterial Vaginosis

*Concept supported by fewer clinical studies

1 everyday intestinal balance

Indica-

tion

1. Everyday intestinal balance
  • Covers a broad range of discomfort such as bloating, slow constipation, diarrhea, and slight irritable bowel
  • Surveys show 15-20% of consumers are concerned about their digestive health
  • 12% of people worldwide suffer from self-defined constipation according to large global omnibus study from 2006
    • Americas and Asia Pacific suffer nearly twice (17%) as much as their European counterparts (9%)
  • 40% of constipation sufferers attempt to treat their constipation by changing their nutrition, despite research showing that diet and lifestyle are not necessarily to blame for the occurrence of constipation
    • Less than 1/3 of sufferers use laxatives
chr hansen offers different indication concepts28

Indica-

tion

Chr. Hansen offers different indication concepts

1. Everyday Intestinal Balance

2. Antibiotic Associated Diarrhea

3. Traveler's Diarrhea

4. Children's Diarrhea

5. Immune Boost

6. Atopic Eczema*

7. Bacterial Vaginosis

*Concept supported by fewer clinical studies

3 traveler s diarrhea

Indica-

tion

3. Traveler's Diarrhea
  • “Travelers' diarrhea is the most common illness affecting travelers. Each year between 20%-50% of international travelers, an estimated 10 million persons, develop diarrhea” -Centers for Disease Control and Prevention, U.S. Department of Health and Human Services
  • Duration of travelers' diarrhea usually limited to 2-5 days
    • In some cases, symptoms may persist for months or even years
  • Probiotic supplementation reduces the risk of diarrhea caused by foreign bacteria from water, vegetables, fruit, etc.
    • Diarrhea is caused mainly by intake of E. coli, Salmonella, or Campylobacter
  • Target group: Those persons traveling to “high-risk” destinations where the food or water supply may contain “non-native” or pathogenic organisms such as E. coli.
chr hansen offers different indication concepts30

Indica-

tion

Chr. Hansen offers different indication concepts

1. Everyday Intestinal Balance

2. Antibiotic Associated Diarrhea

3. Traveler's Diarrhea

4. Children's Diarrhea

5. Immune Boost

6. Atopic Eczema*

7. Bacterial Vaginosis

*Concept supported by fewer clinical studies

5 immune boost

Indica-

tion

5. Immune Boost
  • 80% of the body’s immune cells are located in the gastrointestinal tract
    • Having the right bacterial balance is important for optimizing the immune system
  • Increased levels of IgA and phagocytes (immune cells and cells which can engulf and destroy harmful components), the better the immune system fights unwanted components
  • Probiotics are proven to be able to strengthen natural defenses and stimulate the immune system
  • Immune health is the second largest indication area within probiotics after intestinal health
  • Target group: Those who are under consistently high levels of stress and/or those who have a weak or compromised immune system.
chr hansen s clinically documented probiotic strains
Chr. Hansen’s Clinically-Documented Probiotic Strains
  • Bifidobacterium (BB-12®)
  • Lactobacillus acidophilus (LA-5®)
  • Lactobacillus paracasei ssp. paracasei (CRL-431™)
  • Lactobacillus rhamnosus (GR-1®)
  • Lactobacillus reuteri (RC-14®)
  • Lactobacillus rhamnosus GG (LGG®)
  • Streptococcus thermophilus (TH-4™)

BB-12®

LA-5®

CRL-431™

other chr hansen strains

Strain

Other Chr. Hansen Strains
  • Lactobacillus delbrueckii ssp. bulgaricus LBA-40
  • Lactobacillus delbrueckii ssp. bulgaricus LBY-27
  • Lactobacillus paracasei ssp. paracasei LC-01
  • Lactobacillus rhamnosus LC-69
  • Bifidobacterium infantis BB-02
  • Bifidobacterium longum BB-46
  • Streptococcus thermophilus STY-31
slide34

Strain

Chr. Hansen stains have documented efficacy>450 research and clinical evaluations and >80 human clinical studies
slide35

Strain

Chr. Hansen stains have documented efficacy>450 research and clinical evaluations and >80 human clinical studies
chr hansen with 450 scientific publications

Strain

Chr. Hansen with >450 scientific publications

Scientific publications registered by strain (#)

Source: CH internal abstract database

bb 12 la 5 for everyday intestinal balance clinical study example

Strain

BB-12 + LA-5 for everyday intestinal balanceClinical study example

BB-12 and LA-5 tested on 15 healthy adults with tendency to constipation

Shioya et al.2000

(days)

*

bb 12 for everyday intestinal balance clinical study example
BB-12 for everyday intestinal balanceClinical study example

BB-12 tested on 209 elderly with constipation living in residential homes

Pitkälä et al. 2007

(%)

*

*

quatro cap 4 for lowering risk of traveler s diarrhea clinical study example
Quatro-Cap-4 for Lowering Risk of Traveler's DiarrheaClinical study example

165 tourists going to Egypt were treated with Quatro caps or placebo: 1 cap 3 times daily starting 2 days prior to departure ending the last day of travel

Black et al. 1989 ; Black 1995

Share of tourists with diarrhea

Share of tourists with diarrhea

*

*

Trial I

Trial II

Trial 2

n = 41

n = 40

n = 45

n = 39

slide40

BB-12 for Everyday Immune BoostClinical study example

Effect of BB-12 on phagocytic activity in 14 healthy adults

Schiffrin et al. 1997

Share active phagocytes (%)

*

*

BB-12

dosage forms

Dosage

form

Dosage Forms

Standard forms:

  • Capsules
  • Sticks
  • Powder blends
  • Chewable tablets

Individual customization:

  • Capsules
  • Sticks
  • Chewable tablets
  • Sachets
  • Tablets

and more upon request…

dosage forms for the military

Dosage

form

Dosage Forms….For the Military

1st Choice

Standard forms:

  • Capsules
  • Sticks
  • Powder blends
  • Chewable tablets

Individual customization:

  • Capsules
  • Sticks
  • Chewable tablets
  • Sachets
  • Tablets

and more upon request…

slide43

Dosage

form

Dosage Forms….For the Military

2nd Choice

1st Choice

Standard forms:

  • Capsules
  • Sticks
  • Powder blends
  • Chewable tablets

Individual customization:

  • Capsules
  • Sticks
  • Chewable tablets
  • Sachets
  • Tablets

and more upon request…

dosage form sticks

Dosage

form

Dosage Form: Sticks
  • Best dosage form for wide range of ambient temperature and humidity fluctuations
  • Relatively little loss of viable organisms @ 25C over 18 months
  • Very low sugar content (maximum 0.4 g sugar per dose)
  • Can be customized to contain higher doses to further extend shelf-life over time at various temperature ranges
  • Consumer Appeal
    • Easy to take – no tablets to swallow
    • Easy to consume – only a small amount of powder (1g)
    • Easy to mix into foods and drinks - cold or lukewarm
    • Easy to open – tear off top
    • Easy to carry – in your pocket, bag or lunch box
    • Easy to store – room temperature storage is ok
  • Selections
    • Taste: Vanilla, neutral or per your selection
    • Technology: Soluble or non-soluble
dosage form capsules

Dosage

form

Dosage Form: Capsules
  • Consumer benefits
    • Easy to take – small capsule size
    • Easy to open – for powder administration
    • Easy to carry – Alu-tube or blister card
    • Easy to store – at room temperature
    • Easy to relate to – capsules are a traditional dosage form for supplements
  • Selections for capsule type
    • Type: Gelatin or Vegetables (Vegetable recommended)
    • Size: 000 – 5 (size 3 recommended)
other dosage forms

Dosage

form

Other Dosage Forms
  • Powders
    • Delivered in small vial to consumer to take a tablespoon and sprinkle onto food or beverage
    • Also relevant dosage form when used for infant formula
  • Chewable Tablets
    • Children-friendly
  • Sachets
    • Sachets are quadrant-shaped bags with powder…
    • …different from sticks being rectangle bags
  • Tablets
    • Typically 500-1500 mg per tablet
what is potency

Potency

What is potency?
  • What is a CFU?
    • CFU = Colony Forming Units
    • One CFU = one live bacteria cell
    • “Live” defined as being able to multiple and thereby form a colony
  • How to count the cells?
    • Small amounts of powder is weighing and diluted up to commonly 1,0 E+09
    • Suitable dilutions with lactic acid bacteria are poured onto plates and mixed with medium
    • After anaerobic incubation commonly 3 days at 37oC, the colonies are manually counted
    • Different cell count is seen as cells are live microorganisms
      • Only cells assessed as being colony forming are to be counted
  • What is potency?
    • Potency is minimum number of CFU in one gram (powder) or in one dosage (capsules, tablets, etc)
    • Example: Potency of 1.0 E+09 per capsule means there is minimum 1 billion CFU per capsule
  • Which potency to communicate to consumers?
    • Best practice towards consumers is to state minimum potency at end of shelf life

Chr. Hansen recommends products providing a daily dose of 1 to 10 Bil CFU

chr hansen guarantees potency at point in value chain agreed with customer

Potency

Chr. Hansen guarantees potency at point in value chain agreed with customer

Bulk dosage forms

Final

dosage

form

Powder

production

Boxing &

labeling

Distri-bution

Store

shelfing

Consump-tion

End of

shelf life

Potency

point

#1

Potency

point

#2

Potency

point

#3

Potency

point

#4

Illustrative example of potency decline:

6.5B

5.5B

5B

1B

Chr. Hansen guarantees CFU count all the way to potency point #4 when delivering in final packaging material

the shelf life equation

Shelf

stability

“The Shelf-Life Equation”

=

×

×

Shelf life

Water Activity

Temperature

Oxygen

Rule-of-thumb recommendation:

24 months

=

≤0.15 aw

x

x

≤25OC

≤5%

what we do to maximize shelf stability

Shelf

stability

What we do to maximize shelf stability

I. Strain

  • Strains selected based on superior stability

II. Excipients

  • Excipients with extra low aw chosen

III. Handling

  • Raw materials and products are handled in such a way that we minimize exposure to aw, temperature, and oxygen

IV. Production

  • We minimize mechanical processing
  • We add probiotics as close to final filling as possible
  • We have for customers preparred Standard Operating Procedures
  • We discuss choice of product packaging with our customers
    • Air tight
    • Moisture impermeable
    • Oxygen free (filled with nitrogen)

V. Packaging

types of packaging

Shelf

stability

Types of packaging

Recommended for capsules and tablets

Not recommended

Glass container

Alu-tube

Plastic container

w/ desiccant

Plastic

Container

(PET)

Aclar blister

PVDC-alu blister

Recommended for powder

Not optimal,

but best blister type

Stick

Sachet

Alu-alu blister

desiccant

Shelf

stability

Desiccant applications

Desiccant types

Desiccant

Desiccants reduce water activity level

Water activity

Bentonite

  • Activated clay
  • Absorbs moisture steadily in given period

Silicagel

  • Chemically produced salt
  • Absorbs moisture steadily in given period

Molecular Sieve

  • Crystallized aluminum silicate
  • Absorbs moisture quickly within short period (up to 20% of its own weight)

Desiccant

lid

Desiccant

lining

Desiccant

bags

(Molecular Sieve)

(Molecular Sieve)

moisture vapor transmission rate by type of packaging material

Shelf

stability

Moisture Vapor Transmission Rate by type of packaging material
  • Moisture Vapor Transmission Rate (MVTR)
    • The rate at which moisture will permeate through a barrier over time
    • Measures the barrier performance of different types of packaging
  • Freeze-dried products are very hygroscopic and will absorb available moisture quickly
  • High-barrier packaging materials (glass, aluminum, and plastic vial) are recommended for reducing moisture and oxygen migration.

Plastic vial with desiccant lining permits 0.5mg moisture to enter vial, but desiccant absorbs 1g of moisture

Measured at 37.8°C and 100% RH (g/25μ/m2/day)

summary
Summary
  • Supplementation with Probiotics may help soldiers prevent pathogen-based GI disturbances such as food poisoning, water contamination, etc.
  • Probiotics have been shown to increase the strength of the immune system of individuals who are under chronically-high levels of stress
  • In the field, the best dosage form for soldiers would be the probiotic stick or sachet
  • In the military food service setting, making single serve packets of probiotic capsules available with meals would be ideal.
  • GOAL FOR END RESULT: Improved overall health of the soldiers and thus possibly significant cost savings for the Military (via reduced healthcare and sick leave).
slide55

THANK YOU!

For more information, please contact:

Brian Peeters

usbpe@chr-hansen.com

Office: (415) 503-1834

Together

we improve the quality of

food and health

for people all over the world