Fernando Ferrer MBA probiotics simposium anvisa 19 jun 2017 pdf
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Brazil. The Symposium at the Auditorium of ANVISA was organized by ANVISA, SINDUSFARMA, ABIFISA and ABIAD had the following objective: Discuss the world scenario on the regulation of probiotics and the divergences for the framing of these products in the categories of medicines and foods. The intend was also to discuss requirements for the development, use of claims and production of probiotics. This presentation was to have a dialogue about the STABILITY OF PROBIOTICS
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Fernando Ferrer MBA probiotics simposium anvisa 19 jun 2017 pdf
- 4. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 4 Abstract • Natural products challenge us to create and accept different standards. • Science and usage show us the benefits and safety of using probio3cs. • Food and dietary supplements do not have the same technical requirements of stability for medicines; however, this stability is taken into considera3on from the moment of developing every industrial produc3on formula. • The variety of probio3cs and their mul3ple applica3ons in industrialized products makes it difficult to develop and implement regula3ons covering each and every one of its technicali3es. • This presenta3on shows the stability informa3on of some probio3c products marketed in the US as dietary supplements. • The proposed way to rapidly advance with a regulatory and industrial agreement is to break paradigms for a beTer inclusion of natural products, to seek simpler and broader regula3ons, and to understand and accept the technical reasons considered by industry to neutralize the aspects that may affect the stability of probio3cs in food and medicines.
- 5. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 5 Content Dialogue on the stability of probio3cs ① introduc3on ② Learning from the US Dietary Supplements market ③ discussion Conclusion Fernando Ferrer, MBA Mul3na3onal Partnerships LLC 5
- 6. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 6 Natural products • Natural products are small molecules produced naturally by any organism including primary and secondary metabolites. • They include very small molecules, such as urea, and complex structures, such as Taxol. • As they may only be isolable in small quan33es, have interes3ng biological ac3vity and chemical structures, natural product synthesis poses an interes3ng challenge in organic chemistry. Source: Nature, founded in 1869. hTp://www.nature.com/subjects/natural-products ① introduc3on
- 8. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 8 Bacteria • are among the first forms of life that appeared on Earth • can be found virtually everywhere – at temperature below 0°C or above 120°C – low (0.007 atm) or high pressure (380 atm) – with or without O2 – in radioac3ve waste • are vital for humans
- 10. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 10 Most common microorganisms used as probio3cs • Lactobacillus • Bifidobacterium genera • Other bacterial genera, including Enterococcus, Streptococcus, and Escherichia • Fungus Saccharomyces boulardii
- 11. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 11 FDA Generally Recognized as Safe (GRAS) GRN No. Substance Date of closure 660 Bacillus coagulans GBI-30, 6086 13-Jan-17 601 Bacillus coagulans SBC37-01 spore prepara3on 28-Apr-16 597 Bacillus coagulans SNZ1969 spores prepara3on 29-Feb-16 526 Bacillus coagulans strain Unique IS2 spores prepara3on 23-Mar-15 377 Bifidobacterium animalis subsp. lac3s strain Bf-6 29-Sep-11 445 Bifidobacterium animalis subsp. lac3s strains HN019, Bi-07, Bl-04 and B420 10-Apr-13 455 Bifidobacterium breve M-16V 30-Sep-13 454 Bifidobacterium breve M-16V 27-Sep-13 453 Bifidobacterium breve M-16V 27-Sep-13 49 Bifidobacterium lac3s strain Bb12 and Streptococcus thermophilus strain Th4 19-Mar-02 268 Bifidobacterium longum strain BB536 8-Jul-09 670 Inac3vated Bacillus coagulans GBI-30, 6086 15-Mar-17 Source: webpage FDA, list of some probio3cs listed by May 17, 2017
- 12. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 12 FDA Generally Recognized as Safe (GRAS) (2) GRN No. Substance Date of closure 502 Lactobacillus acidophilus La-14 19-Aug-14 357 Lactobacillus acidophilus NCFM 19-Apr-11 171 Lactobacillus acidophilus, Lactobacillus lac3s, and Pediococcus acidilac3ci 7-Dec-05 429 Lactobacillus casei strain Shirota 10-Dec-12 231 Lactobacillus casei subsp. rhamnosus strain GG 29-May-08 531 Lactobacillus fermentum CECT5716 20-Mar-15 410 Lactobacillus reuteri strain DSM 17938 26-Mar-12 254 Lactobacillus reuteri strain DSM 17938 18-Nov-08 410 Lactobacillus reuteri strain DSM 17938 26-Mar-12 440 Lactobacillus reuteri strain NCIMB 30242 12-Feb-13 288 Lactobacillus rhamnosus strain HN001 1-Nov-09 281 Lactobacillus rhamnosus strain HN001 produced in a milk-based medium 31-Aug-09 Source: webpage FDA, list of some probio3cs listed by May 17, 2017
- 13. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 13 Loses in any food or medical industrialized product Formulas must include overdoses to cover inherent loses in Manufacturing Analy3cal method(s) Storage(s) and logis3cs “One size doesn't fit all”. Varia3ons due to diverse factors, e.g. components, product, forms, technologies, environment, etc.
- 21. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 21 RB– 2 billion viable cells serving 1 capsule Potency is not related to manufacture or expira3on dates :“guaranteed for …labeled potency”, but has a “% of survivability” claim
- 24. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 24 N’s B - 20 billion live cultures serving 1 capsule 20 billion ac3ve cultures per serving guaranteed at the 3me of manufacture. Refrigerate aoer opening
- 27. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 27 Bayer – 2 billion cells serving 1 capsule Prior to expira3on Store at a room temperature. Avoid excessive heat. Replace cap aoer use.
- 29. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 29 Rite Aid – 5 billion CFUs serving 1 capsule Product contains 5 billion live cells when manufactured and a minimum of 1 billion live cells at Eme of expiraEon Store at 25°C (77°F). Avoid excessive heat and humidity. Protect from humidity.
- 32. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 32 Loses in any food or medical industrialized product Formulas must include overdoses to cover inherent loses in Manufacturing 5 – ? % Analy3cal method(s) 5 - 25% Storage(s) and logis3cs ? – 10’000% “One size doesn't fit all”. Varia3ons due to diverse factors, e.g. components, product, forms, technologies, environment, etc.
- 33. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 33 Discussion • Is it feasible for natural products to respond always to the “ra3onal” of synthe3c products created by man? • Is it impossible to create and implement an efficient regulatory system that can fully encompass the wide range of probio3cs? • Is the industry chea3ng the consumers and the authori3es when adding an overdose? ③ discussion
- 34. No
- 35. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 35 Simplicity Complica3ng simplicity is simple but simplifying the complex is very difficult • “Simplicity is the ul3mate sophis3ca3on.” — Leonardo da Vinci • “Don’t make the process harder than it is.“ — Jack Welch • “Life is really simple, but we insist on making it complicated.” – Confucius • “Simplicity is the most difficult thing to secure in this world; it is the last limit of experience and the last effort of genius. “ — George Sand
- 36. Privileged and Confiden3al Fernando Ferrer, MBA © Mul3na3onal Partnerships LLC 36 Conclusion • Break paradigms. Natural products require a different vision than synthe3c products created by man. • Simplify. The wide variety of probio3cs and their applica3ons in the areas of food and medicine can be regulated based on a simple and broad regula3on. • Compliance. Industrialized products require overdosages that are specific to each process and product, levels can not be generalized; the industry is not intending to mislead the system and the addi3on of an overdose is sustained by valid reasons.