R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES

Transcription

1 R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES

2 ID Who are we? - Contract Research Organization providing customized R&D, Testing, Regulatory and Consulting services to the Personal Care, Pharmaceutical, Medical Devices and Food Supplements industries - Founded in 2008 by two researchers from the Pharmaceutical Technology Department of the Faculty of Pharmacy of University of Porto, Portugal

3 ID FOUNDERS: Marta is the General Manager and Technical Director of inovapotek. Holds a master s degree in Pharmaceutical Sciences and a master s degree in Pharmaceutical Technology and has more than 10 years of experience in cosmetics product development, testing and regulatory affairs. Bruno is member of the R&D Advisory Board of inovapotek, Assistant Professor of Pharmaceutical and Biopharmaceutical Technology at IUCS and Affiliated Researcher at i3s/ineb - UP. Holds a PhD in Pharmaceutical Nanotechnology and has more than 12 years of experience in the field, being a globally wellrecognized expert.

4 AREAS PERSONAL CARE PHARMACEUTICAL AND MEDICAL DEVICES FOOD SUPPLEMENTS

5 PERSONAL CARE

6 FORMULATION Formulation development 1 st Search for the best ingredients; 2 nd Formulation Design; 3 rd Experimental development; 4 th Formulations optimization according to organoleptic and sensorial characteristics, preliminary stability studies and client s input. Formulation optimization Improvement of pre-existing formulas, optimizing stability profile, skin feel, tolerance or even regulatory compliance. skin care - hair care - toiletries sun protection after sun - oral care - make-up ALL YOU NEED ONE LAB

7 STABILITY Preliminary stability study (1 month) Accelerated stability study (3 months) Accelerated stability study (6 months) Stability test in real time conditions Compatibility product-packaging test PAO estimation PAO determination (lab test) ALL YOU NEED ONE LAB

8 MICROBIOLOGY Challenge test Total viable count Detection and Identification: Staphylococcus aureus Candida albicans Pseudomonas aeruginosa Escherichia coli Enterobacteriaceae Detection of specified and non-specified microorganisms API biochemical tests for bacterial identification Bactericidal test ALL YOU NEED ONE LAB

9 SAFETY TESTING IN VIVO Acute cutaneous irritation test (Patch test) Cumulative Irritation & Sensitization test (HRIPT) (hipoallergenicity test) Compatibility test (Open test) Tolerance test Tolerance test under gynecologic control Tolerance test under dermatologic control Periocular tolerance test under ophthalmologic control Single ocular instillation study with ophthalmologic control ( Tear-free test) Non-acnegenicity & non-comedogenicity test Stinging test Stinging test in damaged skin Photosensitization test (photopatch test) ALL YOU NEED ONE LAB

10 SAFETY TESTING IN VITRO Ocular irritation test (HET CAM) Mutagenicity test (AMES test) Phototoxicity test 3T3 NRU PT Skin irritation test (OECD 439) Skin corrosion test (OECD 431) Skin absorption studies ALL YOU NEED ONE LAB

11 EFFICCACY TESTING SKIN CARE & TOILETRIES Anti-wrinkles Rejuvenating Anti-ageing Photo-ageing prevention Anti-oxidant Firming Instant lifting Face reshaping Homogeneity of skin complexion Whitening Dark spots decrease Radiance enhancement Anti-puffiness Anti-dark circles Moisturizing Smoothing Desquamation reduction Anti-acne Sebum/oiliness reduction Mattifying Pore size reduction ALL YOU NEED ONE LAB

12 EFFICCACY TESTING SKIN CARE & TOILETRIES Skin barrier protection Skin barrier regeneration Anti-irritant/ soothing Anti-itching Protection against cold weather Increasing of Pain, Heat and/or Cold threshold on healthy or damaged skin Cleansing Anti-pollution Antiperspirant Hair growth decreasing after epilation Self-tanning Slimming Anti-cellulite Stretch marks reduction ALL YOU NEED ONE LAB

13 EFFICCACY TESTING HAIR CARE - EX VIVO Strengthening Heat Damage protection or repair Chemical Damage protection or repair Chloride or sea water damage protection or repair Water / Keratin Quantification (DSC) Curl retention test (hair fixative/styling products) Shine UV protection Color protection Anti-frizz Anti-static Restore of natural movement Combability Silicon Deposition (XRF) Split ends (SEM) Anti-pollution Water absorption ability Moisture holding ability ALL YOU NEED ONE LAB

14 EFFICCACY TESTING HAIR CARE - IN VIVO Hair Growth Hair Loss / Density Hair Thickness Anti-sebum (oiliness reduction) Hair hydration by water quantification Hair strengthening by keratin quantification Hair shine Anti-Dandruff Scalp soothing Professional use test / Salon test ALL YOU NEED ONE LAB

15 EFFICCACY TESTING MAKE-UP: FACE Long-lasting Radiance / Illuminating Skin-tone matching Plumping Imperfections coverage Water-resistance Make-up remover Anti-wrinkles / Smoothing Firming Moisturizing MAKE-UP: LIPS Moisturizing Smoothing Plumping Shine Long-lasting Water-resistance Transfer test Colour coverage ALL YOU NEED ONE LAB

16 EFFICCACY TESTING MAKE-UP: NAILS Time of drying Growth stimulation Long-lasting Color Coverage Color maintenance Water-resistance Detergents-resistance Shine Nail polish adhesion Nail polish durability Abrasion-resistance Smoothing Nail strengthening MAKE-UP: EYELASHES Eyelash enhancement Volumizing Curling Lengthening Water-resistance Long-lasting Growth stimulation ALL YOU NEED ONE LAB

17 EFFICCACY TESTING ORAL CARE In vivo Whitening efficacy Dentin hypersensitivity Anti-microbial Mouth ulcers reduction Fresh breath evaluation Use test Ex vivo Whitening efficacy Enamel resistance to whitening treatments In vitro Anti-microbial Anti-plaque Anti-halitosis ALL YOU NEED ONE LAB

18 SPF TESTING SPF TESTING SPF in vivo determination according to ISO or FDA method SPF in vitro estimation to screen between different formulations during development UVA in vitro determination according to ISO or FDA method SPF boosting efficacy Evaluation of sun products water resistance according to Cosmetics Europe Guidelines. ALL YOU NEED ONE LAB

19 CONSUMER TESTING Evaluation of cosmetic products acceptability by consumers, after its use under pre-defined conditions: - Organoleptic characteristics (colour, odour, aspect, texture, spreadability, absorption rate, etc.) - Efficacy and intensity of perceived effects; - Tolerance - Future use intentions Customized questionnaires ALL YOU NEED ONE LAB

20 SENSORIAL ANALYSIS SKIN CARE & TOILETRIES Discriminative tests (such us Triangle test) Affective tests, Descriptive tests, involving detection (discrimination) & description of qualitative and quantitative sensory aspects of a product by trained panels according to ASTM E : - Appearance: amount of spread, thickness, ease of dispensing - Pick-up : Amount of peaking, firmness, stickiness - Rub-out : spreadability, absorbency, thickness - After-feel : slipperiness, moisture, stickiness, greasiness, oiliness, silkiness, soft finish, etc. ALL YOU NEED ONE LAB

21 SENSORIAL ANALYSIS HAIR CARE Hair tresses Subjects (half and whole heads) Sensory aspects of a product assessed by trained panels according to ASTM E : - Appearance: firmness, integrity of shape, transparency, pearlescence - Pick-up : firmness, stickiness; - Application and foam characteristics: ease of spreading, speed to foam, amount of foam, cushion of foam, bubble size, ease of rinsing; - Wet hair characteristics: ease of detangling, force to comb, slipperiness, residue (greasy, oily); - Dry hair characteristics: ease of detangling, force to comb, slipperiness, residue (greasy, oily), static, etc. ALL YOU NEED ONE LAB

22 REGULATORY Formula Review Cosmetic Product Safety Report (CPSR) Elaboration of both part A and part B of the CPSR according to Annex I of the EU Regulation nr.1223/2009. Claim Substantiation Elaboration of a claim substantiation report according to Commission Regulation (EU) No 655/2013 of 10 July 2013, and respective guidelines Product Information File (PIF) Elaboration of the PIF according with EU Regulation nr.1223/2009. Label Review Notification to EU Authorities (CPNP) ALL YOU NEED ONE LAB

23 CONSULTING & TRAINING R&D project management & consulting: Scientific support in the development of ingredients Bibliographic research Selection and design of complete lines of cosmetics Project management Writing of scientific texts: sales and marketing material papers, posters and presentations Training sessions GMP implementation according to ISO ALL YOU NEED ONE LAB

24 PHARMACEUTICAL AND MEDICAL DEVICES FORMULATION QUALITY CONTROL R&D PROJECTS

25 FORMULATION -Development of classical formulations liquids, semi-solids and solids -Development of controlled-release formulations -Development of new drug delivery systems drug incorporation in microparticles microcapsules nanoparticles and nanocapsules Formulation optimization Improving stability, organoleptic characteristics (aspect, flavour and odour), drug delivery, drug absorption; etc.

26 QUALITY CONTROL & STABILITY -Development and validation of analytical HPLC methods for the assay of drug substances and related compounds -Stability studies according to ICH Guidelines

27 R&D PROJECTS Development of R&D projects in collaboration with: - Scientific and technological institutions, - R&D companies, - Pharmaceutical and medical devices industries The perfect SME partner for consortium R&D projects Inovapotek s experts are specialized on: - Development of functionalized nanomedicines - in vitro cell models as a tool to evaluate the transport of drugs and nanoparticles and perform in vitro/in vivo correlations - Validation of new functionalized nanoparticles for diagnosis and - Modulating nanoparticles mucoadhesion

28 FOOD SUPPLEMENTS FORMULATION QUALITY CONTROL EFFICACY TESTING CONSUMER TESTING

29 FORMULATION FORMULATION DEVELOPMENT 1 st Search for the best ingredients; 2 nd Formulation Design; 3 rd Experimental development; 4 th Formulations optimization according to organoleptic and sensorial characteristics, preliminary stability studies and client s input. fully customized, innovative, stable, safe, effective supplements

30 QUALITY CONTROL & STABILITY STABILITY STUDIES Whether for formulation development, or as control of the finished product, stability studies of supplements ensure the product is stable along storage time. Stability studies can be performed according to standard protocols or in customized conditions.

31 EFFICACY TESTING SKIN Anti-wrinkles Rejuvenating Anti-ageing Firming Moisturizing Smoothing Sebum/oiliness reduction Anti-acne Skin barrier protection Skin barrier regeneration Self-tanning Slimming Anti-cellulite HAIR Growth Loss Thickness Density Anti-sebum (oiliness reduction) Anti-dandruff Water / Keratin Quantification NAILS Growth stimulation Shine Strenghtening

32 CONSUMER TESTING Evaluation of cosmetic products acceptability by consumers, after its use under pre-defined conditions: - Organoleptic characteristics (colour, odour, aspect, taste, etc.) - Efficacy and intensity of perceived effects - Future use intentions. Customized questionnaires

33 OUR CLIENTS USA Canada Belgium Ireland France Spain UK Monaco Sweden Netherlands Germany Switzerland Italy Japan Portugal Morocco Israel Mexico Algeria Emirates South Korea Brazil South Africa Australia

34 CERTIFICATIONS Spin-off of University of Porto ISO 9001 Certified Approved by the French Ministry of Higher Education and Research (Crédit d'impôt Recherche) Approved by the Portuguese Ministries of Economy, Innovation and Development and of Science, Technology and Higher Education (SIFIDE)

35 PARTNERSHIPS PARTNERSHIPS: Amial Dental Clinic Gaia Hospital MEMBERSHIPS:

36 FACILITIES

37 FACILITIES

38 FACILITIES EQUIPMENT o o o o o o o o o o o Cutometer MPA580, Courage-Khazaka Sebumeter SCC 815, Courage-Khazaka Corneometer CM 825, Courage-Khazaka Tewameter TM 300, Courage-Khazaka Colorimeter CL 400, Courage-Khazaka Glossimeter GL 200, Courage-Khazaka Optical 3D in vivo skin measuring system PRIMOS TM premium, GFM Visioface 1000D, Courage-Khazaka Trichoscan Smart, Tricholog GmbH & Datinf GmbH Texture meter Stable Micro Systems Etc

39 TEAM TEAM 13 full-time collaborators: - 2 PhD & 7 Masters in the Technical Department pharmaceutical sciences, biotechnology, biomedical engineer, biochemistry, chemistry 2 dermatologists 1 ophthalmologist 1 gynecologist 1 quality management expert

40 ORGANIZATION QUALITY MANAGEMENT SYSTEM - The inovapotek quality management system (QMS) fulfills the requirements of ISO 9001: Main goal: - continuous improvement - client s satisfaction - The documental structure of inovapotek QMS has 3 different levels: A: QUALITY MANUAL B: PROCESSES C: SOPs AND OTHER CONTROLLED FORMS

41 PROJECT MANAGEMENT Mod.003 Proposition Study Plan and Tecnhical Records Mod.034 Report ALL YOU NEED ONE LAB

42 MISSION: VALUES: TO BE IN THE SCIENTIFIC RESEARCH VANGUARD IN THE COSMETIC AND PHARMACEUTHICAL TECNHOLOGY FIELDS, PROMOTING THE DEVELOPMENT OF INNOVATIVE PRODUCTS THAT MEET THE CONSUMERS DEMANDS AND NEEDS

43 R&D, TESTING AND REGULATORY SERVICES TO THE PHARMACEUTICAL AND PERSONAL CARE INDUSTRIES