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Clinically-Documented Probiotics for Human Health

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1 Clinically-Documented Probiotics for Human Health
*It is recommended to make pdf file if you want to share slides with a customers as: 1) This presentation contains internal notes in the commentary field. 2) Less risk that slides are changed and used in undesired context Brian Peeters Strategic Sales Manager Chr. Hansen A/S

2 Agenda Introduction Why Chr. Hansen as Preferred Supplier
Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

3 Chr. Hansen… …when science matters 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 *Chr. Hansen was until 2005 listed on Copenhagen Stock Exchange until it was acquired by a French private equity fund, PAI Partners. *Change in ownership has resulted in divestment of non-core business while accelerating growth in existing business – especially probiotics …when science matters

4 Chr. Hansen Group serving global customers all over the world with >25 offices

5 Chr. Hansen Organizational Structure
Health & Nutrition Division is dedicated solely to Probiotics Chr. Hansen Cultures & Enzymes Natural Colors Health & Nutrition *HND is one of Chr. Hansen’s three divisions *Flavour division was in spring 2008 sold to German Symrise

6 Chr. Hansen - World’s Largest Lactic Acid Bacteria Plant Location: Avedore, Denmark

7 Agenda Introduction Why Chr. Hansen as Preferred Supplier
Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

8 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 *The >450 studies include studies done in vivo (outside living organism), animal studies and human studies. The >80 studies include only human studies done according to highest standards (double-blinded placebo controlled)

9 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 *Chr. Hansen is to our knowledge the only probiotic supplement producer with pharma cGMP approval !!! *Most products are allergen free covering Big-8 (US) and Big-14 (EU) including for example lactose, fish, peanut, etc.. All products are GMO free *When we state ”Pharma cGMP” we refer to that we produce according to ”European Pharmacopoeia” which is a reference work for the quality control of medicines in Europe and is controlled by “The Council of Europe”. *Note ”Council of Europe” (47 member states; 800 citizens) is a larger gathering than the European Union (27 member states; 500 citizens) also covering countries such as Russia. *LABIP = Lactic Acid Bacteria Industrial Platform

10 Agenda Introduction Why Chr. Hansen as Preferred Supplier
Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

11 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.”

12 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 *The probiotics depicted is BB-12 *The official definition from WHO on probiotic is: ‘Live microorganisms which when administered in adequate amounts confer health benefits of the host’ *There are more than 1000 different bacteria species in the human body. 80% have not yet been cultured *Metchnikoff studied peasants who had long life spans and linked their longevity to their diet, which included large amounts of fermented milks *Europe: First probiotic yogurts launched in beginning of 1980’ies but with limited succes. Market took off with Danone’s Activia launch in France in 1987 *US: Increasing interest said to be driven by success of Dannon’s Activia launched in January 2006 (60M USD promotional campaign gave 130M USD revenues first ten months according to NBJ) *GI tract may be largest immune organ in body – but even more important is the GI tracts function in regards to nutritional intake. The GI tract is the machine converting food to energy and right bacterial balance ensure the machine is well-oiled.

13 Strain Taxonomy Note: 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 Enterococcus fermentum F-19 Weissella reuteri Carnobacterium delbrueckii *This slide is best presented from right to left starting with the strains. The grey boxes shows where in the taxonomy tree the strains belong *Note that LAB is not a true part of the biological taxonomy - but used in popular terms *There are 14 known genus of LAB – only 7 are shown here, but this changes over time as new genus are discovered (Bifodobacterium, Lactobacillus, Pediococcus, Leuconostoc, Weissella, Oenococcus, Enterococcus, Carnobacterium, Streptococcus, Lactococcus, Vagococcus, Aerococcus, Alloiococcus, Tetragenococcus) *There are 111 known species of Lactobacillus – only 7 are shown here. This changes over time. New species are found, some are merged and others are moved to other genus. *There are 29 known species of Bifidobacterium. Source for both numbers are “Chr. Hansen Innovation group” *There are no public known estimate of number of LAB strains. But just in Chr. Hansen cell bank there are single strain deposits. *A sub-species can be repeating the species name like ”Lactobacillus paracasei subspecies paracasei” *Some strains does not have a sub-species group, but goes directly from species to strain. Streptococcus rhamnosus Lactococcus plantarum

14 Probiotics – Mechanisms of Action
Inhibit adhesion of pathogen cells Produce surface- active substances Produce hydrogen peroxide Inhibit growth of pathogen cells acids Produce bacteriocins Inhibit growth of pathogens Work as co-aggregation molecules Block the spread of pathogens Strengthen the immune system Modulates cytokine production Probiotic strain *Some probiotic strains produce lactic acids from various sugars thereby lowering the pH. This is typical for the lactobacilli. *Some probiotic strains produce antimicrobial substances. E.g. LA-5 produces a bacteriocin; RC-14 produces H2O2; etc. *Some probiotic strains compete for intestinal adhesion sites. This makes adhesion of pathogenic cells more difficult. E.g. BB-12

15 Probiotics – Mechanisms of Action
Inhibit adhesion of pathogen cells Produce surface- active substances Produce hydrogen peroxide Inhibit growth of pathogen cells acids Produce bacteriocins Inhibit growth of pathogens Work as co-aggregation molecules Block the spread of pathogens Strengthen the immune system Modulates cytokine production Probiotic strain *Some probiotic strains produce lactic acids from various sugars thereby lowering the pH. This is typical for the lactobacilli. *Some probiotic strains produce antimicrobial substances. E.g. LA-5 produces a bacteriocin; RC-14 produces H2O2; etc. *Some probiotic strains compete for intestinal adhesion sites. This makes adhesion of pathogenic cells more difficult. E.g. BB-12

16 Agenda Introduction Why Chr. Hansen as Preferred Supplier
Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

17 Scientific interest in probiotics has grown significantly since 2000…
PubMed Articles on Probiotics (#)

18 …and so has the number of probiotic trials
Probiotic trials registered on NIH (#) US trials Non-US trials

19 Increasing interest in probiotics seen in recent years Dietary supplements: Gone from 16 launches in ‘02 to 75 launches in ‘07 Probiotic product launches globally (#) 669 594 Other 491 394 Cheese Diet. suppl. 242 150 Fermented milks *The year used is the year where Mintel noticed the new product. Could have been launched earlier so may see examples of lagging effect. *Does not show number of products on the market, but just new launches *Increasing number of product launches is a strong indicator that product producers are willing to invest in a specific product area *Product launches in 2008 shows the trend continues *Yogurt, supplements and cheese are the 3 largest categories of probiotic products. Others include smaller categories like milk, candy, beverages, and baby-food. Source: Mintel database; Global launches

20 ~35% average annual growth last 5 years
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 38 Europe 31 16 Japan US *Recognize the 51 and 75 from previous slide Source: Mintel database; Global launches ~35% average annual growth last 5 years

21 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 *Demographic shifts refers to baby-boomers of the 1940’ies are reaching retirement age becoming big part of population. At the same time average life time expectancy is increasing also increasing share of elderly population. *Self-medication follows trend on ”prevention rather than cure” *Consumer awareness of probiotics or ”good bacteria” was in 2006 in example 40% in UK and 42% in Sweden. Source is HealthFocus International which conducts such health awareness studies in 32 countries every second year or so. There were 800 responds in Sweden and 500 in UK. Consumer awareness below 50% in most countries

22 Agenda Introduction Why Chr. Hansen as Preferred Supplier
Basics of Probiotics Market Trends Designing a Probiotic Product for the Military

23 Designing a Probiotic Product for the Military
1 Indication 8 2 Other Regulatory / Claim Shelf stability Your product Strain(s) 7 3 Potency Survival through stomach Dosage form 6 4 5

24 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 *Some customers may see an advantage in combining #1-3 in an overall GI product given product seasonality (Everyday = All year; AAD = winter; Traveler’s = Summer) *Another possible combination of indications is combining intestinal balance and immune boost in a multi-product - commonly seen in US products. Or giving the AAD concept a differentiation by adding immune boost. *Concept supported by fewer clinical studies

25 Chr. Hansen offers different indication concepts
1. Everyday Intestinal Balance 3. Traveler's Diarrhea 5. Immune Boost *Some customers may see an advantage in combining #1-3 in an overall GI product given product seasonality (Everyday = All year; AAD = winter; Traveler’s = Summer) *Another possible combination of indications is combining intestinal balance and immune boost in a multi-product - commonly seen in US products. Or giving the AAD concept a differentiation by adding immune boost. *Concept supported by fewer clinical studies

26 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 *Some customers may see an advantage in combining #1-3 in an overall GI product given product seasonality (Everyday = All year; AAD = winter; Traveler’s = Summer) *Another possible combination of indications is combining intestinal balance and immune boost in a multi-product - commonly seen in US products. Or giving the AAD concept a differentiation by adding immune boost. *Concept supported by fewer clinical studies

27 1. Everyday intestinal balance
Indica- tion 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 *Source on 15-20% is Nutrition Business Journal, 10 Key Trends report, 2007 CONSTIPATION *The epidemiology survey explored duration and frequency of constipation in 13,879 participants from four continents. The article “The BI Omnibus Study: An international survey of community prevalence of constipation and laxative use in adults” by Wald A, Kamm MA, Müller-Lissner SA, Scarpignato C, Marx W, Schuijt C. was published in Digestive Disorders, May 2006. *Another study shows that half of pregnant women become constipated sometime during pregnancy. Article published in “Obstetrics & Gynecology” journal in December 2007.

28 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 *Some customers may see an advantage in combining #1-3 in an overall GI product given product seasonality (Everyday = All year; AAD = winter; Traveler’s = Summer) *Another possible combination of indications is combining intestinal balance and immune boost in a multi-product - commonly seen in US products. Or giving the AAD concept a differentiation by adding immune boost. *Concept supported by fewer clinical studies

29 3. Traveler's Diarrhea Indica- tion “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. Source is CDC as stated in slide

30 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 *Some customers may see an advantage in combining #1-3 in an overall GI product given product seasonality (Everyday = All year; AAD = winter; Traveler’s = Summer) *Another possible combination of indications is combining intestinal balance and immune boost in a multi-product - commonly seen in US products. Or giving the AAD concept a differentiation by adding immune boost. *Concept supported by fewer clinical studies

31 5. Immune Boost Indica- tion 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. *Combination of indications is also a possibility. In example combining intestinal balance and immune boost in a multi-product. Or giving the AAD concept a differentiation by adding immune boost.

32 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™

33 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 *This is the so-called ”secondary strains”

34 Antibiotic Assoc. Diarrhea
Strain Chr. Hansen stains have documented efficacy >450 research and clinical evaluations and >80 human clinical studies Strains Intestinal balance Antibiotic Assoc. Diarrhea Traveler's Diarrhea Children's Diarrhea Immune boost Atopic Eczema Bacterial Vaginosis BB-12 7 2 3 4 BB-12 + LA-5 6 BB-12 + TH-4 CRL-431 1 CRL BB-12 LGG 15 BB-12 + LGG BB-12 + LA-5 + LBY-27 + STY-31 + LGG GR-1 + RC-14 8 *Note that a BB-12 and LA-5 blend for everyday intestinal balance is supported not only by the 5 AB studies, but also by the 7 BB-12 studies. Same logical reasoning goes for the rest *Number of studies is not a good proxy for strain efficacy. Validity of each study is more important. E.g. The 1 immune study with CRL-431 study is better than the 3 BB-12 immune studies together.

35 Antibiotic Assoc. Diarrhea
Strain Chr. Hansen stains have documented efficacy >450 research and clinical evaluations and >80 human clinical studies CHR Product Strains Intestinal Balance Antibiotic Assoc. Diarrhea Traveler's Diarrhea Children's Diarrhea Immune Boost Atopic Eczema Bacterial Vaginosis BB-12 Stick BB-12 7 2 3 4 AB-Cap BB-12 + LA-5 6 BB-12 + TH-4 CRL-431 1 CRL BB-12 LGG 15 BB-12 + LGG Quatro-Cap BB-12 + LA-5 + LBY-27 + STY-31 + LGG GR-1 + RC-14 8 *Note that a BB-12 and LA-5 blend for everyday intestinal balance is supported not only by the 5 AB studies, but also by the 7 BB-12 studies. Same logical reasoning goes for the rest *Number of studies is not a good proxy for strain efficacy. Validity of each study is more important. E.g. The 1 immune study with CRL-431 study is better than the 3 BB-12 immune studies together.

36 Chr. Hansen with >450 scientific publications
Strain Chr. Hansen with >450 scientific publications Scientific publications registered by strain (#) Source: CH internal abstract database

37 BB-12 + LA-5 for everyday intestinal balance Clinical study example
Strain BB-12 and LA-5 tested on 15 healthy adults with tendency to constipation Shioya et al.2000 (days) *

38 BB-12 for everyday intestinal balance Clinical study example
BB-12 tested on 209 elderly with constipation living in residential homes Pitkälä et al. 2007 (%) * *

39 Quatro-Cap-4 for Lowering Risk of Traveler's Diarrhea Clinical 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 ; 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

40 BB-12 for Everyday Immune Boost Clinical study example
Effect of BB-12 on phagocytic activity in 14 healthy adults Schiffrin et al. 1997 Share active phagocytes (%) * * BB-12

41 Dosage Forms Standard forms: Capsules Sticks Powder blends
Chewable tablets Individual customization: Sachets Tablets and more upon request…

42 Dosage Forms….For the Military
1st Choice Standard forms: Capsules Sticks Powder blends Chewable tablets Individual customization: Sachets Tablets and more upon request…

43 Dosage Forms….For the Military
2nd Choice 1st Choice Standard forms: Capsules Sticks Powder blends Chewable tablets Individual customization: Sachets Tablets and more upon request…

44 Dosage form Dosage Form: Sticks Best dosage form for wide range of ambient temperature and humidity fluctuations Relatively little loss of viable 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

45 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)

46 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 mg per tablet

47 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 *Scientific Marketing can support the customer in deciding on product potency once it is determined which indication area and strain will be used. Potency in existing products in the market should also be taken into consideration. *Chr. Hansen recommendation of 1-10B CFU is based on results from our >80 human clinical studies. This is also in line with e.g. Consumer Lab recommendation. Consumer Lab is a US based company providing independent test results and information to help consumers and healthcare professionals evaluate health, wellness, and nutrition products. Chr. Hansen recommends products providing a daily dose of 1 to 10 Bil CFU

48 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: *Potency decline from powder production to consumption. *Regarding potency point 1-2: Expire date is months after delivery *Regarding potency point 3-4: -Actual potency will depend on chosen dosage form (caps, sticks, etc), packaging material (alu tubes, etc), temperatures and moisture conditions during production of final product, etc. -Chr. Hansen has preformed many studies to define optimal condition to ensure promised potency counts at end of shelf life -Chr. Hansen has written guideline to our customers with recommendation on the further handling and processing of the probiotics to minimize the cell count 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

49 “The Shelf-Life Equation”
stability “The Shelf-Life Equation” = × × Shelf life Water Activity Temperature Oxygen Rule-of-thumb recommendation: 24 months = ≤0.15 aw x ≤25OC x ≤5%

50 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

51 Types of packaging Recommended for capsules and tablets
Shelf stability Types of packaging Recommended for capsules and tablets Not recommended Alu-tube Glass container 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 *Aclar blister looks exactly like PVDC-alu blister but is slightly better. However not good enough too keep moisture out *What is commonly mentioned as a “PVC-alu” if often actually a “PVDC-alu” as this is better *Shown plastic container is from PET *Only 0-10% of CFUs are remaining after 12 months when using one of the “Not recommended” packaging types.

52 Desiccant Desiccant types Desiccant applications
Shelf stability Desiccant Desiccant types Desiccant applications Desiccants reduce water activity level Bentonite Activated clay Absorbs moisture steadily in given period Silicagel Chemically produced salt Molecular Sieve Crystallized aluminum silicate Absorbs moisture quickly within short period (up to 20% of its own weight) Water activity Desiccant lid Desiccant lining Desiccant bags (Molecular Sieve) (Molecular Sieve)

53 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. MVTR examples Glass Aluminum HDPE 3,8 PVDC 4,0 PP 6-10 LDPE 18-23 PET 19-46 Plastic vial with desiccant lining permits 0.5mg moisture to enter vial, but desiccant absorbs 1g of moisture *HDPE (High Density Polyethylene) is the a high density version of PE plastic *PVDC (Polyvinylidene Chloride) is a polymer derived material mostly used as a thin barrier layer in multilayer sheet, film and tube. *PP (Polypropylene) is a thermoplastic polymer used in a wide variety of applications including reusable containers of various types *LDPE (Low Density Polyethylene) is a thermoplastic made from oil *PET (Polyethylene terephthalate) is a thermoplastic polymer. Non-reusable beverage bottles where the plastic is light and soft is often made of PET MVTR is technically not the appropriate metric to use when assessing the viability of a desiccated vial. MVTR implies "transmission" through the sidewall. That does not "capture" the moisture ingression through the seal area. The "Total" moisture ingression rate is the most relevant metric but only in relation to the amount of absorption capacity present. In short, the CSP vials permits ~.5mg of moisture to enter the container on a daily basis at 22C, 80%RH. The desiccant in our vial can absorb ~1g of moisture. So, the vial will provide RH protection for ~2000 days. Measured at 37.8°C and 100% RH (g/25μ/m2/day)

54 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).

55 THANK YOU! Together food and health
For more information, please contact: Brian Peeters Office: (415) Together we improve the quality of food and health for people all over the world


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