From chemical development to high value products 06/2018 1 OUR SCIENCE, YOUR PRODUCT
What we do Custom design and production of specialty chemicals, intermediates and APIs 2 OUR SCIENCE, YOUR PRODUCT
Who we are A Swiss chemical company founded in the thriving business environment of Zurich in 2001. We have since grown to a global provider with a portfolio of 2500 products, which we deliver to over 20 European countries, all over the Americas and Asia. 3 OUR SCIENCE, YOUR PRODUCT
Why choose us We combine Swiss excellence with high-end European R&D expertise and low development and production costs. We use intellectual property strategically, which gives us greater corporate flexibility and increased market value of our products. We are trusted by the world’s leading chemical and pharmaceutical companies. 4 OUR SCIENCE, YOUR PRODUCT
Our approach We apply cost-performance benchmarks on a project-by- project basis to find the best solution for our customers’ project. We are proactive and anticipate any regulatory bottlenecks with a view to mitigate business risks and reduce time-to-market. We use all our resources to design and implement innovative processes to produce your product sustainably and ensure uninterrupted supply for your business. 5 OUR SCIENCE, YOUR PRODUCT
Global presence VIO Chemicals AG – HQ Zurich, Switzerland R&D Centre Thessaloniki, Greece China Representative Office Nanjing, China Manufacturing site (VIO Organic Chemicals Co. Ltd. /Yangcheng HaoHua) Binhai, China Sales Offices & Agents in North America France Spain Japan 6 OUR SCIENCE, YOUR PRODUCT
Our facilities – The R&D centre A powerhouse of science at highly competitive rates • A team of 35 highly experienced scientists and professionals • Primary focus on innovative, non-patent infringing, safe and robust processes • Over 150 publications in prime journals with average impact factor >4 • More than 30 patent filings Organic OS: 7 PhD, 6 MSc Synthesis Analytical Development IP AD: 3 PhD, 5 MSc, 1 BSc Scientific QA/RA QA/RA: 1 PhD, 2 MSc Affairs IP/ScA: 2 PhD, 1 MSc + Management: 1 PhD / 1 MSc 7 OUR SCIENCE, YOUR PRODUCT
Organic synthesis lab 8x Fume Hoods 4x Rotary evaporators 1x Flow chemistry system 1x Gas reaction module Ozonolysis equipment Vacuum Pumps Drying & vacuum ovens 8 OUR SCIENCE, YOUR PRODUCT
Kilo lab 2x 50L Reactors (-45 to 150°C) 1x 30L Reactor (-35 to 150°C) 1x 20L Reactor (-40 to 150°C) 1x 5L Reactor (-30 to 150°C) 1, 2 and 5L High Pressure Reactors Nutsche filter, Centrifuge 20L Rotary Evaporator 9 OUR SCIENCE, YOUR PRODUCT
Analytical development labs 7x HPLCs (Shimadzu), with UV, PDA, RI, ELS, FR detector options 1x Preparative HPLC (Shimadzu) 1x LCMS (Shimadzu) 1x FTIR (Perkin Elmer) 2x GC (Shimadzu) 1x Digital Polarimeter (Perkin Elmer) Stability Chambers (short/long term) Photostability Chamber 10 OUR SCIENCE, YOUR PRODUCT
Our facilities - The manufacturing site Reliable, flexible, cost-efficient and prompt manufacturing services 11 OUR SCIENCE, YOUR PRODUCT
Our facilities - The manufacturing site State-of-the-art production assets • VIO Organic Chemicals Co. Ltd, registered in China as Yangcheng HaoHua • More than 4,500 m² of manufacturing space in a total plot area of 27,000 m² • Three production units, one cGMP standard • High flexibility in production capacity, with volume ranging from grams to metric tons • Clean room for the production of intermediates, ISO Class 8 • Multi-purpose and single product plants with medium to high throughput • Glass-lined and stainless steel reactors from 500L to 5,000L • Broad range of technologies and types of chemical reactions • Specialization in enzymatic processes for chiral products • Close collaboration with an enzyme developing company • Waste management system for solid, gas and water according to local regulations • Water purification system • Solvent recycling technology • Strict compliance with local health, safety and environmental policies and regulation • ISO 9001 certification for Quality Management System • Continuously aiming for green chemistry. 12 OUR SCIENCE, YOUR PRODUCT
Our services • R&D • Manufacturing • Strategic sourcing • Integrated support and consultancy in QA, IP and RA 13 OUR SCIENCE, YOUR PRODUCT
R&D and manufacturing High-value, cost-competitive and non-infringing solutions Process R&D We optimise or re-design the chemical process to arrive at your exact product. Our goal is to improve yields and the overall quality of your product and minimise production costs. Analytical research, development and validation We undertake full characterisation analysis to ensure the highest quality for the properties of your product. Technology transfer and production We develop chemical transformations to safe, robust, scalable and exactly repeatable manufacturing processes. 14 OUR SCIENCE, YOUR PRODUCT
R&D and manufacturing Our approach for high-value products From Europe to China Evaluation & Research & Technology Scale-up Inquiry Design Development Transfer Manufacturing • • Innovative and efficient processes Wide range of technologies • • Overcome key constraints Cost-effective solutions • • Overcome patent protection Sustainable processes 15 OUR SCIENCE, YOUR PRODUCT
How we do it ISO 9001 & 14001 certification and GMP-compliant quality system IP generation existing novel process process Regulatory/LCM implementation and clearance tech process development control and scale up support Research & Technology Evaluation & Scale-up Inquiry Design Development Transfer Manufacturing QA monitoring supply chain CM evaluation IP quality best analytical and support QA/IP support and assignment landscape process control development Stage Gate Project Management System Stage Gate Project Management System The work performed in the lab involves process and analytical development , including proper IP support, and delivers a full technical package for technology transfer to the manufacturing unit, backed with quality assurance and regulatory insight and support for commercialization . The R&D centre: • is certified according to ISO 9001 & ISO 14001 since 2006, with the scope of “Research and development of Active Pharmaceutical Ingredients” . • functions within an integral Stage-Gate Project Management System , which implements and updates an established Quality Management System , with written Standard Operating Procedures. That way we can ensure traceability throughout the developing process by following basic GMP documentation requirements. 16 OUR SCIENCE, YOUR PRODUCT
Stages-Gates Workflow ISO 9001 & 14001 certification and GMP-compliant quality system Customer involvement throughout the whole process Quality System - Project Management System Evaluation & Design Research & Development Tech-transfer & Scale-up SG1: Project framing SG3: Feasibility SG6: Technology Transfer • Inquiry elucidation/ Market intelligence • Proof-of-Concept and Feasibility studies • Key Raw Material suppliers approval • Goal framing and project outlook • IP generation and Optimal ROS • Manufacturer quality status and • Target selection/acknowledgment selection technical evaluation and assignment • Prior art, IP landscape and • Manufacturing technology transfer existing technology evaluation SG4: Optimization • Analytical method transfer • Identification and evaluation of • Assessment/preparation of impurities • Lab familiarization and process constraints Lab samples and Reference Standards implementation troubleshooting • Potential involvement strategies • Analytical method development • Intermediates and product SG7: Scale-up manufacturing SG2: Project evaluation and design specifications • Process scale-up/ piloting and • Novel approach ideation vs prior art • Pre-stability/ holding time studies commercial production • New technologies potential • Commercial production • Shadow cost benchmarking and SG5: Lab Validation • troubleshooting • Analytical Method validation/protocols competition evaluation • Commercial cost calculation • Targeted properties and specifications • Raw Material Cost calculation • QA and RA support for registration • Targeted quantities and timelines • Technology Transfer Document and lifecycle management • Full Technical Package R&D Process for Scale-up Best Approach Proposals Scale-up material 17 OUR SCIENCE, YOUR PRODUCT
R&D carbohydrates expertise 18 OUR SCIENCE, YOUR PRODUCT
R&D carbohydrates expertise highlights 19 OUR SCIENCE, YOUR PRODUCT
R&D two main methodologies to access key synthons γ - aminoacids α - substituted γ - aminoacids non-natural Starting from α -aminoacids renewable sources Hetero Diels-Alder e.g. pyruvates Intramolecular Intramolecu Starting from polyhydroxylate cyclization lar carbohydrates d carbocyclics cyclization Intramolecular cyclization carbasugars, cyclopentyl- carbocyclics 1,3-aminoalcohols, carbocyclic nucleosides 20 OUR SCIENCE, YOUR PRODUCT
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