Introduction to NOVOCAT FARMA Formulation Development Services
2017 Our Global Footprint
United Kingdom (HQ)
Cambridge China
United States Chengdu, Sichuan
Philadelphia
New Zealand Auckland Czech Republic
Prague
Romania
India
Mumbai
Research Facilities
NOVOCAT has expanded its R&D capabilities into a 1500 square meter, state- of-the-art lab to meet the increasing formulation and analytical testing demands from its global client pool located at Barcelona
NOVOCAT formulation scientists operate a Good Laboratory Practice (GLP) compliant analytical facility, registered with International Accreditation New Zealand (IANZ), under a co-development agreement with Auckland University l
www.elc-group.com Product Expertise and Capabilities
SOLID ORAL DOSAGE FORMS QbD Implementation for new product development . •Tablets & capsules, including modified/delayed/ controlled release/ MUPS/ fixed-dose combinations •Oral disintegrating tablets/films, effervescent tablets Developing drug products with patent non-infringing drug formulations for US, Europe, Canada, Brazil, South LIQUIDS & SEMI-SOLIDS* Africa, Australia, WHO-PEPFAR •Liquids, suspensions, syrups markets. •Powder for oral suspension •Creams, lotions, gels, ointments End to end product delivery support •Ophthalmic drops, Otic/nasal drops from product identification to IP STERILE INJECTABLES* evaluation, formulation, scale-up, technology transfer, BE studies, •Clear injectable solutions registration, assistance in query •Pre-filled syringes •Lyophilized powder for suspension for injection response, life cycle management and •Liposomes (Micro and Nano tech) licensing.
*Through channel partners R&D Team Head: Profile
R&D expertise Australia and USA EU Canada Russia/CIS South Africa Asia-Pacific
13 29 5 25 17 13
• More than 30 years of experience in heading R & D Teams
• Co-inventor of more than 30 registered patents, and delivered more than 100 products for diverse global markets (see regional distribution below)
• 4 First-to-File (Para IV) products developed for US Market, involving 3-Platform PCT patents.
• Expert in QbD development for new products, CRAMs business model and evaluating REMS strategies.
• Involved in globalization of product development by “bridging/cloning” to different regulated markets R&D Team Expertise
Avg. No. of Dosage Forms Designation Qualification Market Expertise Therapeutic Areas Experience Personnel Handled Technical Team Team Leaders Tablets/Capsules Anti-Neoplastic (Oncology): 6 Formulation . Immediate Release Abiraterone, Erlotinib Ph. D / Masters in US 12-19 years . Extended release Pharmacy. Europe Team Leaders . Controlled and Anti-Hypertensive (Cardiovascular): 6 Canada Analytical Delayed release Atenolol/ Nifedipine ER Tablet in Capsule LATAM Oral liquids Senior Managers ASEAN 6 . Solutions Immunomodulators (Multiple Sclerosis): Formulation Australia/New . Suspensions Fingolimod, Teriflunomide, Dimethyl Fumarate DR Zealand Liposomes GCC Master of Science / Dermal / transdermal Anti-Coagulants: 8-12 years Russia/CIS Senior Managers Masters in Pharmacy Emulsions Dabigatran 6 MENA Analytical Depotherapy WHO-PEPFAR Ophthalmic Metabolic Disorder (Diabetes): Metformin ER, Sitagliptin/Metformin Injectables
Junior Scientists Gastric Acid Secretion Inhibitor: 5 Formulation Esomeprazole MUPS Tablets
Anti-retroviral: Masters in Pharmacy Darunavir, Tenofovir / Masters in Science / US Immediate and Extended 5-6 years Bachelors in EU Antidepressants (CNS): Junior Scientists release oral dosage forms 18 Pharmacy / Bachelors Rest of World Duloxetine DR, Fluoxetine DR Analytical in Science Anti-inflammatory/allergy: Ebastin ODT, Fexofenadine/Pseudoephedrine ER, Zileuton ER List of Equipment
Dispensing Granulation Room II Liquid Formulation Microbalance and Weighing Balance Extruder 60- Spheronizer 250 Stirrer Homogenizer Sifting &Milling Compression Room I SS Jacketed Mixing Tank Vibratory Sifter Mini Tablet Presses SS Vessels Oscillating granulator CEMECH R & D Tablet Press Packing Multimill Dehumidifier Elmach Blister Packing Machine Manual Sifter Weighing Balance Pouch Sealing Machine Fluid Bed Processing Room Compression Room II Leak Test Apparatus Mini Rotary Tableting Bilayer Laboratory Stirrers Capsule Filling Room Magnetic Stirrers with heater Weighing Balance MF 30 Deluxe Manual Capsule Filling High Shear Homogenizer Machine Hot Plate IPQC Room Dehumidifier Peristaltic Pump Hardness Tester Weighing Balance Fluid Bed Processor with 6” Wurster Halogen Moisture Analyzer Tray Dryer Karl Fischer Titrator Coating Room Planetary Mixer DT Apparatus Peristaltic Pump Weighing Balance Tapped Density Tester Automatic Coating for Tablets Granulation Room I & Blending Electromagnetic Sieve Shaker Stirrer Rapid Mix Granulator Friabilator Colloidal Mill V-Blender (2L, 8L) Brookfield Viscometer Homogenizer Octagonal Blender Vernier Caliper Weighing Balance pH Meter
List of Equipment
Gas Chromatography Room HPLC Room Stability Room Gas Chromatography Assembly Shimadzu HPLC (16) Stability Chambers for: Shimadzu UFLC (1) Dissolution Room . 40°C ± 2 °C/75% RH ± 5% RH Agilent HPLC (8) . 30°C ± 2 °C/75% RH ± 5% RH Electrolab Dissolution Tester (3) 8 bowls with . 30°C ± 2 °C/65% RH ± 5% RH Auto sampler Balance Room . 25°C ± 2 °C/60% RH ± 5% RH LabIndia Dissolution Tester (3) 14 bowls with Analytical Balance . 2°C to 8°C auto sampler Micro Balance Photo Stability Chamber Semi Micro Balance Instrumentation Lab Cold Cabinet pH Meter Wet Lab Karl Fischer Titrator Fume Hood Refrigerator Melting Point Apparatus Cooling Chamber UV-VIS Spectrophotometer pH Meter UV Cabinet Pure Water System Vacuum Oven Ultrasonic Bath Cleaner Micro Osmometer Centrifuge Hot Lab Balance Water Batch Temperature Cyclo Mixer Controller Orbital Shaker Wrist Shaker Hot Plate Hot Air Oven Product Development to Technology Transfer
Q0 Q1 Q2 Q3 Q4 Q5 Q6 Q7 Q8
Milestone I Project sign off
Formulation Development: Interim Product Development Report with Comparative dissolution results Milestone II against RLD and 1 M stability data
Milestone III 3 Months Stability Data of Selected Prototype: stability data of prototype
Milestone IV Pilot Batch Manufacturing: samples of Pilot Batches
*Timeline is not universally Milestone V Stability studies on pilot batches: stability data of pilot batches proportional and may Scale up and formulation optimization studies: formulation differ based on product Milestone VI complexity optimization report
Analytical method validation: analytical method validation report Milestone VII
Scale up, technology transfer, process optimization studies at CMO/client site: technology transfer report Milestone VIII
Analytical method transfer: analytical method transfer report Milestone IX
Project Consultation and registration batch manufacturing: execution of the exhibit batch Milestone X Completion Full Process Overview
QP declaration
Medical writing
RA Scientific Submission advice strategy Distribution Licensing Preclinical and Marketing Formulation clinical Authorization Batch release development strategy Application Batch testing
Post Product Preclinical Clinical Regulatory Commer- Early development Registration approval development Phase Phase approval cialization (LCM)
API Preclinical Clinical GMP Variations Manufacturing studies studies, Mock Audit Renewal API Sourcing BE studies GMP Training Transfer Withdrawal Dossier P&R preparation GAP Analysis, Pharmacovigilance eCTD
RESEARCH APPROVAL COMERCIALIZATION Business Models
Fee for Service
Co-Development
Portfolio Development / Management
Lab to Market ELC Product List
• ELC’s current Product Development portfolio:
Active Ingredient Dosage Strengths Pharmaceutical Form Therapeutic Area
Abiraterone 250mg Tablet Oncology Ticagrelor 60mg, 90mg Tablet Cardiovascular Apixaban 2.5mg, 5mg Tablet Cardiovascular Azilsartan 20mg, 40mg, Tablet Cardiovascular Medoxomil 80mg Sacubitril/ Valsartan 24/26mg, 49/51mg, Tablet Cardiovascular 97/103mg Apremilast 10mg, 20mg, Tablet Immunology 30mg Canagliflozin 100mg, 300mg Tablet Metabolic Disorder Canagliflozin/ 50/500mg, 50/1000mg, Tablet Metabolic Metformin 150/500mg,150/1000mg Disorder Linagliptin/Metformin 2.5mg:1gm, 2.5mg:500mg, Tablet Metabolic 2.5mg:850mg Disorder • Name your product…
THANK YOU FOR YOUR ATTENTION