[ PHARMACEUTICAL DEVELOPMENT SOLUTIONS ] For every method.

Transcription

1 [ PHARMACEUTICAL DEVELPMENT SLUTINS ] Shaping Success in Pharmaceutical Development For every method. Every step of the way.

2 [ PHARMACEUTICAL DEVELPMENT SLUTINS ] Uncover inefficiencies. Maximize return on investment. Partner with Waters to get you there. Today. Developing innovative medicines is challenging enough without the added pressure of having to do it faster than ever before with the same or fewer resources. No matter the size of your organization, the goal is the same: move through development quickly without compromising data quality or increasing costs. And help your organization s products get to market sooner, successfully. How do you get there? Start by implementing solutions that enable you to develop information-rich, reliable analytical methods from day one containing the details necessary to make critical decisions at any step in the development process. Make that knowledge globally accessible so that progress never stops. By working with Waters, you can readily advance your analytical technologies in a way that makes a difference to your company s bottom line.

3 We at Waters understand the critical workflow challenges in drug development laboratories where streamlining the process of method scouting, optimization, validation, and transfer is of utmost concern. Everything we do focuses on continued innovation in laboratory instrumentation, chemistries, and software to address these issues. Key to our success is making our customers successful. By fostering and sharing our applications expertise, we make sure that scientists can maximize the impact of these technologies to exceed their business, research, or organizational goals. Forward-looking companies are fast realizing that Waters solutions generate benefits and cost savings that extend into every area of drug development and turn great scientific ideas into successful products. Arthur G. Caputo Executive Vice President, Waters Corporation, and President, Waters Business perations

4 If top 20 companies are to deliver sales growth they will need to dramatically improve R&D productivity those that cannot dramatically increase both the number and quality of drugs will go the way of the dinosaurs. 1 Do one week s worth of method scouting in just one day Detect peaks before they become a problem BEH Phenyl BEH C18 Simvastatin UV 238 nm?? H 3 C H 3 3 H C CH CH3 H 3C FW: BEH Shield BEH C8 Intensity Intensity 2.0x x x10 6 MS TIC Peak not identified by UV The range of selectivities available with Waters HPLC and ACQUITY UPLC Columns allows you to quickly determine the best methodology for your sample. UPLC Method Scouting 2.1 x 50 mm, 1.7 µm Acid acetonitrile screen* 2 hours 12 hours Acid methanol screen* 2 hours 12 hours Basic acetonitrile screen* 2 hours 12 hours Basic methanol screen* 2 hours 12 hours TTAL 1 day 5 days *4 columns: 2 blanks, 2 replicates + re-equilibrate HPLC Method Scouting 4.6 x 150 mm, 5 µm 5.0x The easy-to-use ACQUITY UPLC System with the ACQUITY UPLC Photodiode Array Detector and SQ Mass Detector provides rapid and comprehensive peak detection. PRE-CLINICAL LEAD PTIMIZATIN METHD SCUTING the analyst can achieve fast, efficient, and reproducible methods. The results are compelling that 1.5 to 2 µm sized porous stationary phase particles used with high-performance instrumentation such as the ACQUITY UPLC will become the option of choice for the development of fast LC methods in pharmaceutical development Nova rt is LCGC No rth Am eri ca 2 FRCED DEGRADATIN all of the major degradation products and impurities were separated by the UPLC approach but in half of the time required by the HPLC... [with] a flatter baseline, sharper peaks, and very good retention time precision. An additional benefit with the UPLC method is that the mobile phase consumption was only about 20% of that of the HPLC method. Ast razeneca Jou rnal of Ch r o mat o g r a p h y A 3

5 Developers, both large pharma and small/mid-tier pharma, are implementing new technologies to reduce late-stage failures and contain rising development costs. 4 Improved operational efficiencies. In plain numbers. Total number of injections for sample set (Sample, standards, QC sample, blank) Run time per injection at 1 ml/min (Equilibration time, run time, analysis time) HPLC UPLC Number of runs stays the same 50 min 12 min Total analysis time for injection set hr hr Total volume of solvent per analysis 2945 ml 696 ml Cost of solvent per liter $3.93 $3.93 Solvent cost per analysis $11.57 $2.73 Solvent disposal cost $23.13 $5.47 Total solvent usage cost $34.70 $8.20 Analysis time reduces from 50 to 12 minutes per run Net cost in solvent use decreases from over $34 to under $9 per analysis Total analytical time reduces from more than 6 business days to less than 2 by using UPLC for sample set Total cost for solvent use decreases by $1537 by using UPLC for sample set To support your overall business goals, the advantages of switching to UPLC are clear. With a focus on the bottom line, ensure that your scientists exploit every advantage that UPLC brings to separations science. From instrumentation operation and maintenance to applications and information management solutions, Waters has educational courses to help your company maintain performance and compliance, while enhancing productivity. CANDIDATE SELECT IMPURITY PRFILE Don t be caught off-guard by pre-existing impurities late in development. Acquire comprehensive impurity profiles with high resolution, sensitive ACQUITY UPLC methods. STABILITY The [UPLC] method was completely validated showing satisfactory data for all the parameters tested. This method exhibited an excellent performance in terms of sensitivity and speed. It is a stability indicating method suitable for rapid analysis of primaquine bulk drug and its impurities. Univ e rsit y of Mum bai, India Jou rnal of Pharmaceuti cal an d Biom edi cal Analysis 5 RUTE PTIMIZATIN NEVER let analytical support be a bottleneck in process chemistry. With UPLC, enable faster decision-making for choosing the right synthetic conditions.

6 The fastest performing companies terminated projects earlier in development 56% of all discontinued projects were terminated in Phase I. 4 Information-rich content for confidence through late-stage development Eliminate errors and reduce validation time by 50 to 80% Simvastatin API % Excipients Acid Acetate Anhydro Dimer Time UPLC produces separations that are both high resolution and fast. Develop assays with SP-driven compliant validation with Empower 2 Method Validation Manager. MVM collects and processes all validation data needed, eliminating manual data entry and reducing validation time by 50 to 80%. IN & CNFIRMATIN FRMULATIN DEVELPMENT With Quality by Design taking hold in development, the number and complexity of potential formulations has increased dramatically. Keep up with formulators analytical demands with ACQUITY UPLC separations, and batch processing and reporting with Empower 2 Software. METHD VALIDATIN The industry is very much in need of a workflow-based, configurable system that seamlessly implements method validation requirements but is inherently flexible and manages the data, [that] effectively standardizes an often tedious and time-consuming process. SUBMIT IND Jam e s Morgado Pfizer Global R&D

7 Drugs developed by the fastest companies gained an average $1.1 billion each in incremental prescription revenue compared to those of the slowest companies. 4 No matter where in the world data acquisition takes place, all of your information is centrally located Know that instrument uptime is maximized Waters NuGenesis SDMS LABRATRY STUDY DATA Chromatography data MS data UV data GC data LIMS data Balance measurements Excel, Word, Visio, PDF, or scanned content ELECTRNIC SCIENTIFIC DATA MANAGEMENT SYSTEM Captures, reports, and archives data from any and all lab instruments. Centralizes e-information management of data storage, signatures, workflow, and approval. SCIENTIFIC DCUMENT MANAGEMENT AND E-SUBMISSIN Automates scientific data entry into Electronic Common Technical Document (ectd) standard formats for regulatory submissions. 21 CFR 11 compliant data management Streamline regulatory processes by automatically capturing, reporting, archiving, and transferring data for IND/NDA submissions with NuGenesis SDMS. Rely on real-time worldwide Waters support with Connections INSIGHT remote monitoring and diagnostics. CLINICAL Phase I / II / III LNCH QC & MANUFACTURING Accelerated Stability Are your methods reliable enough to accurately define the shelf life and packaging of your product? Expedient method scouting with UPLC allows more time to be allocated to optimizing your method for robustness, resulting in long-term analytical method stability. SCALE-UP When material is representative of the commercial end product, you can t afford to miss any critical analytical information. The combination of ACQUITY UPLC System and Columns with Empower 2 Software s peak detection capabilities gives you comprehensive sample analysis every time. SUBMIT NDA TRANSFER T QC Without Connections INSIGHT Software, I would have lost an entire day s worth of work. The value of Connections INSIGHT technology is that it provides early warning of system issues that can be fixed quickly and in most cases, eliminates the need for an on-site visit... QC c h emis t Contract manufacturing lab A partnership with Waters provides you with the comprehensive laboratory technologies and expertise that enable you to get through development faster and smarter. Learn more at

8 Sales ffices: Austria Australia Belgium and Luxembourg Brazil Canada China Czech Republic Denmark Finland France Germany Hong Kong Hungary India Ireland Italy Japan Korea Mexico The Netherlands Norway Poland Puerto Rico Russia/CIS / Singapore Spain Sweden Switzerland Taiwan UK US The best solutions for Pharmaceutical Development n ACQUITY UltraPerformance System and Columns For reliable sensitivity, resolution, and analytical speed. n Empower 2 Software with Method Validation Manager Chromatography data management software for any size laboratory. n NuGenesis Scientific Data Management System (SDMS) Captures, reports, and archives data from all lab instruments. n Waters Mass Spectrometry From single or tandem quadrupole to time-of-flight, for complete MS information. n Waters Global Services No matter where you are located, the service, support, and training to keep your lab operating at its maximum. References 1. Pharma 2005: An Industrial Revolution in R&D. PricewaterhouseCoopers. Nov The Use of ACQUITY UPLC in Pharmaceutical Development. Jerkovich A, Lobrutto R, Vivilecchia R. Pharmaceutical and Analytical Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, U.S.A. Supplement to LCGC North America. 2005; Use of Ultra-Performance Liquid Chromatography in Pharmaceutical Development. Wren SA, Tchelitcheff P. Analytical Development, PAR&D, AstraZeneca, Cheshire, UK. J Chromatogr A Jun 30;1119 (1-2): Tufts Center for the Study of Drug Development Impact Report. Sept/ct 2006, Vol 8, No Development and Validation of UPLC Method for Determination of Primaquine Phosphate and its Impurities. Dongre VG, Karmuse PP, Rao PP, Kumar A. Department of Chemistry, University of Mumbai, India. J Pharm Biomed Anal Sep Waters Corporation 34 Maple Street Milford, MA U.S.A. T: F: Waters, ACQUITY UPLC, ACQUITY UltraPerformance LC, Connections INSIGHT, NuGenesis, and UPLC are registered trademarks of Waters Corporation. Empower and The Science of What s Possible are trademarks of Waters Corporation. All other trademarks are the property of their respective owners Waters Corporation. Printed in the U.S.A. February EN LB-CP