TAKE PHARMACEUTICAL DEVELOPMENT TO THE NEXT LEVEL WITH ARCINOVA
FAST FORWARD TO MARKET WITH ARCINOVA Discovery Preclinical Clinical Market Integrated scale-up & Trusted discovery partners Trusted clinical partners manufacturing • Shorten your time to clinic − Integrated project teams on site reduces ‘hand-over’ time − Pragmatic application of cutting edge technologies to reduce development time − Partnership with global discovery service provider addresses scale-up challenges up-front − Partnership with global CRO ensures seamless hand over into the clinic • Reduce your risk of failure − Drug substance, analytical and drug product development needs are taken into account at all stages
LOCATION One Single Facility Site Area:~12.8ha Building Footprint ~10,000 m 2 (2/3 laboratory space)
MODERN, WELL-EQUIPPED SITE WITH A RICH HISTORY… • Over 200 customers worldwide • > 80 US/Canada • > 80 Europe • 18 in Japan • Biotechs, speciality pharma, large pharma • Over 180 staff
WHAT MAKES US DIFFERENT?
WHAT MAKES US DIFFERENT? • Big company track record/compliance − 38 years successful delivery of projects − Continuity… as Arcinova supported 10 INDs and 20 IMPDs since 2016 − Exemplary quality/compliance record… MHRA average IMP GMP Feb 2017 API GMP June 2019 Critical 0.5 0 0 Major 8 0 0 Other 12 5 3 • Speed, agility and flexibility of a small company − Competitive lead times − Full range of contract structures (fee for service, FTE, multi-FTE, etc.) − Facility, setup and culture to deliver highly bespoke/custom projects • Fully integrated provider all under 1 roof…
INTEGRATEDDRUG DEVELOPMENTALL UNDER ONE ROOF
PROJECT LEADERSHIP Dr Ellie Row, Head of Client Services Integrated suite of services under 1 roof, unified project culture • Dedicated project leaders for every project • Transparency and regular client communication ARCINOVA • Strong project measurement and continuous improvement culture
DRUG SUBSTANCE • Grammes to multi kilos • GMP/non-GMP ARCINOVA • Candidate to phase 2 and beyond (low volume)
LEADERSHIP TRACK RECORD • >30 projects since 2018 • >50 clients • Often complex chemistries (>10 steps) CAPABILITIES • 11 PR&D, 4 manufacturing chemists • 3 x 5L streams • 2 x 20L streams Dr Paul Quigley • 2 x 100L streams (online end 2020) >30 years scale-up • Flow chemistry experience − Flowsyn − Salamander • High temperature − 200°C flow, 300°C trickle bed • High pressure (200Bar flow, 100 tb) • Filter drying 500g to 15Kg
DRUG SUBSTANCE – Why Arcinova? Reduce your costs • Typical 50% reduction in manufacturing cost from initial to phase I ready process Shorten your time to clinic • Pragmatic deployment of technology, engagement with analytical and formulation development on-site can save months of development time
DRUG SUBSTANCE CASE STUDY Integrated Project for US Biotech Client Rapid development of a scalable route towards an analogue of a new drug substance, with definition of an Challenge: optimal salt form for formulation Customer: US Biotech client developing combined Small Molecule / Biologic immunotherapy treatments ARCINOVA developed two process route options to the drug substance and selected one on the basis of Outcome: scalability and process economy. The API free base was generated and a rapid salt screening protocol undertaken. A solubility study was undertaken which showed optimal solubilisation at a set pH. The client was delighted and has filed provisional IP. The drug substance analogue shows superior solubility to the prime API. The case study demonstrates the power of the integrated drug substance / drug product development capacity at Arcinova. Client’s current ARCINOVA Project Drug Substance Objectives Conclusions • A shorter synthesis • Develop a route(s) • Requires a complex was developed towards an analogue in synthesis • Solubility of the final 15 weeks • Drug product drug form was • Improve scalability isolated as an markedly improved amorphous solid • Improve solubility • Six salt forms tested • Poor solubility • Perform a salt • The new analogue • No saltform screenprotocol showed similar activity available towards the biological target
ANALYTICAL SCIENCES • Preclinical to post marketing testing • Microbiology ARCINOVA • Stability testing
LEADERSHIP TRACK RECORD • >300 projects • >100 clients CAPABILITIES • 19 analysts • Chromatography − Potency, impurities/degradation products − Enantiomers, residual solvents David Wilson − Quantification of GTI’s >30 years in − Cleaning verification methodology analytical sciences • Range of detection types − UV, DAD, N2 Emission, Radiochemical, MS, ICP-MS, Conductivity, Fluorescence, CAD − HPLC/UPLC, Intrinsic/conventional dissolution − Infrared/UV spectroscopy, high resolution mass spectrometry − Karl Fischer water content, water activity − Walk-in ICH compliant stability chambers − Photostability testing − 14C and high potency handling capabilities
ANALYTICAL SCIENCES – Why Arcinova? Your challenging problems solved • Track record of resolving non-routine characteristics associated with drug substances and excipients Shorten your time to clinic • Engagement with on-site DS and DP teams can save months of development time
ANALYTICAL SCIENCES CASE STUDY Chromatographic Development and the Application of a Diverse Service Range Challenge: Development of a modern, single, chromatographic procedure for a marketed tablet product that would allow the resolution and quantification of four active species and each of their associated impurities / degradation products. Customer: Multinational Consumer Goods Company A single LC gradient procedure capable of resolving the multiple species involved, was successfully Outcome: developed and validated. Application of the methodology revealed a previously unknown impurity in the product batches provided. In order to help the client reach an informed conclusion regarding this situation, a diverse range of in-house services were engaged. New Client able Impurity to Make Found Informed Decisions
FORMULATION DEVELOPMENT • Preclinical and clinical formulation • Salt selection ARCINOVA • Polymorph studies • Physical characterisation and excipient selection
LEADERSHIP TRACK RECORD • >100 projects • >60 clients CAPABILITIES • 12 FD scientists • 500 MHz solid-state and solution-state NMR • High-resolution mass spectrometry • ICPMS Professor Stephen Byard • X-ray diffraction, Thermal analysis >35 years in pharmaceutical and • Laser diffraction, Particle size sciences • Nitrogen/krypton sorption surface area Secretary of the RSC NMR Group dynamic vapour sorption • Attenuated total reflectance and diffuse reflectance infrared spectroscopy • Semi-automated crystallisation
FORMULATION DEVELOPMENT – Why Arcinova? Your challenging problems solved • Proven ability to resolve previously intractable formulation challenges Shorten your time to clinic • Engagement with DS team ensures early attack on potential formulation issues
FORMULATION DEVELOPMENT CASE STUDY Drug Substance Salt Selection To manufacture drug substance and screen a selection of corresponding pharmaceutically acceptable salt Challenge: forms. From the resulting salt forms, choose a candidate which exhibits optimal characteristics for formulation and bioavailability. Customer: US Biopharmaceutical. API was manufactured at ARCINOVA, and a series of salts subsequently produced. Each salt form was assessed Outcome: with respect to salt formation, solubility, hygroscopicity, crystallinity, polymorph tendency, chemical stability and particle size/morphology. An optimal salt form was identified and manufactured at ARCINOVA. Dynamic VapourSorption Optical Microscopy 20 mW Salt formA Scanning ElectronMicroscopy Differential ScanningCalorimetry Salt formB Solid-state NMR
DRUG PRODUCT MANUFACTURE • Preclinical to phase 2, oral & IV • Cytotoxics & radiolabelled compounds ARCINOVA • Nanocrystals
LEADERSHIP TRACK RECORD • >60 projects • >30 clients CAPABILITIES • 6 DP manufacturing scientists • Oral • Capsules, powder in a vial, dry blends 10,000 per batch Dr Simon Fuller • Molded chewable tablets >35 years pharmaceutical 1,000 per batch manufacturing experience • Solutions/emulsions/suspensions 20L/per batch • IV – suitable to support human AME and phase I studies • Quantos, Xcelodose, 3P R1000 • Esco homogeniser • Emulsiflex and milling technologies
DRUG PRODUCT MANUFACTURE – Why Arcinova? Reduce your costs • Scalable capacity, ensuring flexible service delivery across phase 1 and phase 2 clinical trials Shorten your time to clinic • Proven track record for accelerated product manufacture and clinical delivery • Fully integrated packaging, labelling and distribution
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