Drive Process Productivity

Transcription

1 Solutions for the Biopharmaceutical Industry Drive Process Productivity Innovative solutions from a proven technology leader

2 Your partner in productivity Whether you are developing a process for a novel biotherapeutic or verifying procedures for final product release, Applied Biosystems provides powerful process and analytical solutions that can move your product ahead and accelerate your time to market. Biopharmaceutical Product Development Overview

3 Solutions for Characterization, Purification and Quality Control As a leading provider of process and analytical solutions for the biotechnology and pharmaceutical industries, Applied Biosystems offers an extensive portfolio of tools to help optimize every stage of biopharmaceutical production from product characterization to purification to quality control. These solutions provide biopharmaceutical manufacturers the information they require to maximize throughput and yield and ensure product quality.

4 Get all the details Product analysis and process characterization Biopharmaceutical compounds are highly complex, heterogeneous, and subject to modification, including glycosylation, charge variants, and aggregates. Early stage product development requires detailed characterization of any modifications or structural features that may impact product activity and quality as well as product yield. High performance mass spectrometry (MS) is often the method of choice for these applications. characterize biopharmaceutical proteins and provide detailed information for critical studies, such as comparability, stability, and drug product quality. Detailed Monoclonal Antibody Analysis Applied Biosystems, in partnership with MDS Analytical Technologies, is a leading innovator in mass spectrometry. Our MS solutions are used throughout the life science industry to Applied Mass Spectrometry Biosystems/MDS Solutions Analytical Technologies Solutions QSTAR Elite quadrupole TOF System 4800 Plus MALDI TOF/TOF Analyzer 4000 QTRAP hybrid quadrupole LIT System 3200 QTRAP hybrid quadrupole LIT System Mass spectrum of partially deglycosylated monoclonal antibody showing loss of glycan structures. Bringing clarity to characterization Mapping and quantitation The QSTAR ELITE LC/MS/MS System provides high resolution, mass accuracy, and sophisticated software required for detailed characterization of heterogeneous therapeutic proteins. Speed and power The 4800 Plus MALDI TOF/TOF Analyzer combines the convenience of MALDI with the power of highresolution MS/MS for detailed characterization of glycans and other protein modifications. Compliance and validation Analyst Software offers a comprehensive suite of features for 21 CFR Part 11 compliance, including complete, role-based security, auditing, and electronic records. Applied Biosystems also provides comprehensive Analyst Software Validation Services and instrument verification services.

5 A thriving culture In addition to structural information, detailed characterization of biopharmaceutical products requires accurate amino acid quantitation and cell culture optimization. Applied Biosystems has leveraged the power of MS to create amino acid analysis (AAA) systems that are faster, more reliable, and more accurate than conventional systems. While the Amino Acid 20/20 Analyzer System is designed for monitoring 20 amino acids in protein hydrolysates and culture media, the Amino Acid 45/32 Analyzer System expands the range to 45 amino acids and also allows analysis in physiological fluids. Rapid process monitoring Applied Biosystems POROS Perfusion Chromatography analytical columns are today s best performing columns for rapid and robust separations of biopharmaceuticals. POROS Protein A columns are the industry standard for monitoring Monoclonal antibody titer and yield at every process step from cell culture to downstream purification. Rapid Protein A Assay for Monoclonal Antibody Quantitation from Cell Culture Supernatant Rapid results The Amino Acid 20/20 Analyzer, the first complete MS-based system for amino acid analysis, enables you to quantitate 20 amino acids from protein hydrolysate samples twice as fast as existing chromatography systems. High throughput analysis POROS Analytical columns enable rapid and robust quantitation of your protein of interest or impurities from complex samples. Amino Acid Analysis Solutions Amino Acid 20/20 Analyzer System Amino Acid 45/32 Analyzer System POROS Analytical Columns Affinity (Protein A, Protein G) Ion Exchange Reversed Phase Metal Chelate

6 Applied Biosystems chromatography solutions provide a streamlined purification scale-up strategy based on performance, speed, and efficiency. High performance on a large scale Protein purification High performance on a large scale Product purification involves several critical steps, each one of which must be designed and optimized during research and early stage development, then scaled up for commercial manufacturing. Ideally, purification procedures developed during the early stages of process development can be optimized and scaled-up directly to manufacturing levels without sacrificing performance efficiency. POROS Perfusion Process Scale Chromatography Media rprotein A Affinity (including new MabCapture A) Strong Cation Exchangers Strong Anion Exchangers hlgg Capacity at 5% Breakthrough vs. Linear Velocity Weak Anion Exchangers Heparin Affinity Reversed Phase Metal Chelate A selection of selectivities A broad range of POROS media are available for production-scale, lab-scale, and quality control applications. All 50-micron POROS products are backed by full regulatory support information and Drug Master Files. The new POROS MabCapture A is the highest performance process scale protein A media, providing the highest dynamic binding capacity and capture efficiency over the broadest flow rate range.

7 A tradition of quality POROS media was introduced in 1990 and has been manufactured at large-scale since Today, POROS media is used in the manufacture of numerous FDA-approved biotherapeutics and many products in various stages of development. Removing scale-up bottlenecks Protein purification Applied Biosystems POROS MabCapture A Perfusion Chromatography Media offer a direct and cost-effective path from lab-scale to production-scale bioseparations. These rigid, robust particles enable high-resolution separations with 2-3X the throughput of conventional fast-flow gels. The unique throughpore structure of POROS media is designed to provide unmatched dynamic binding capacities and excellent capture efficiencies at high linear velocities, resulting in smaller column volumes, reduced buffer consumption, and faster processing for higher product throughput. With the recent improvements in cell culture technology resulting in higher expression levels, higher capacity process scale media is needed. Applied Biosystems newest POROS affinity media, POROS MabCapture A, was specifically designed to address this need. MabCapture A provides up to 130% increased productivity High Capacity Protein A New MabCapture A solves the purification bottleneck caused by high expression cell culture.

8 Protect your brand with rapid genotypic-based solutions Process monitoring and quality control Even with optimal purification, biopharmaceutical products can be contaminated by objectionable organisms such as bacteria and fungi, as well as residual DNA. These contaminants can compromise process performance and product quality and may lead to product recalls, lost manufacturing time, lost revenue, and decreased consumer confidence. Better answers Conventional methods for detecting and identifying biological contaminants are labor intensive, time intensive, and prone to error. Molecular methods (genotypic or DNA-based) are now available that offer superior speed and accuracy and faster time to results. Proven solutions Applied Biosystems provides an expanding portfolio of solutions for detection, enumeration, and identification of biological contaminants in biopharmaceutical processes and products. With the MicroSeq Microbial Identification System and qpcr assay solutions, manufacturers are equipped to protect their brands and accelerate time to market. Genotypic methods have been shown to be more accurate and precise than traditional biochemical and phenotypic methods. These methods are especially valuable for investigations of failures. FDA Guidance for Industry Sterile Drug Products Produced by Aseptic Processing. USFDA, September 2004, Pharmaceutical cgmps.

9 The MicroSeq System was 100% accurate, with 100% reproducibility at identifying 18 American Type Culture Collection (ATCC) strains of organisms most frequently encountered in pharmaceutical manufacturing environments. Royal Pharmaceutical Society, February Accurate microbial identification Process monitoring and quality control The MicroSeq system utilizes state-of-the-art ribosomal RNA gene (rdna) sequencing to identify microbial contaminants. The system sequences the universal 16S rdna for bacterial identification, and the D2 region of the large subunit (LSU) rrna gene for fungal identification. After sequencing, the MicroSeq system automatically compares the results to the MicroSeq library, which contains over 2800 validated microbial sequences such as gram-negative non-fermenters, Bacillus, coryneforms, and Staphylococcus, along with yeast and molds. Accuracy adds confidence With the MicroSeq system, you can identify microbial species in less than 5 hours, using a simple MicroSeq Microbial Identification Systems MicroSeq 3130 Microbial Identification system MicroSeq 3130xl Microbial Identification system Reagent Kits for Bacterial and Fungal Identification workflow with minimal hands-on time. No previous sequencing experience is necessary. MicroSeq software also includes comprehensive features for 21CFR Part 11 compliance. Applied Biosystems provides comprehensive system installation qualification and operational qualification (IQOQ) to support validation of the hardware, software and chemistry for the MicroSeq system.

10 Microbial detection and enumeration Process monitoring and quality control Unparalleled sensitivity and specificity Applied Biosystems qpcr detection systems utilize realtime PCR to detect and quantitate specific objectionable organisms (specified by the US, European, Japanese and other Pharmacopeia) as well as residual DNA. These real-time systems are more sensitive than traditional methods and over 100 times more sensitive than most immunoassays. This level of sensitivity ensures the detection of target organisms in as few as five hours, compared to several days with conventional methods. Critical decision support Through its sophisticated informatics, assay design, and manufacturing capabilities, Applied Biosystems has made a wide range of pre-configured and customized assays qpcr Microbial Pathogen Detection Detection Kits Kits Salmonella enterica Pseudomonas aeruginosa Staphylococcus aureus Custom Residual qpcr DNA Detection and Quantification Kits Escherichia coli Chinese Hamster Ovary available. A streamlined 3-step workflow enables users to obtain accurate, genetic-based results quickly and with minimal hands-on time. The system requires no prior knowledge or expertise in real time PCR. Kits include species-specific reagents, universal running conditions, and a simplified workflow with minimal hands-on time.

11 Go live faster with pre-configured, pre-validated LIMS Laboratory information management Applied Biosystems develops fully integrated laboratory information management solutions, our SQL*LIMS Suite, that address the complete manufacturing QA/QC process, including lot/batch management, environmental monitoring, quality event/deviation tracking, stability study and inventory management, and ELN integration. With over 30,000 users, SQL*LIMS is the perfect choice for your LIMS solutions. By pre-configuring and pre-validating the SQL*LIMS Plug & Play Pharma Package (P4) system to a common set of Industry Best Practices, a potential customer can decrease their time to deployment by up to 75% and their deployment costs by up to 85% versus what is needed with any typical COTS (Commercial Off The Shelf) LIMS product. Save up to 85% in LIMS implementation costs and 75% in time with our SQL*LIMS P4 Business Solution. Value-added partnership Services and support With over 25 years of experience in the service of innovative instruments and with over 1000 trained, dedicated service professionals, AB Global Services is the perfect choice as your high-value partner. Instrument Repair and Maintenance Get the highest quality, worldwide Best in Class support available for Applied Biosystems products. Smart Services Help increase your instrument uptime and optimize processes with our automated, real-time remote instrument monitoring and diagnostics service. Qualification Services Our Qualification Service includes Installation and Operation Qualification (IQOQ), as well as Instrument Performance Verification (IPV) after maintenance, repair, or instrument move. Professional Services Experienced, scientific domain professionals deliver a wide range of critical services including: software validation to support 21 CFR Part 11 compliance, software interfacing, networking and database support. Applied Biosystems project managers are PMO certified. On-Site Application Consulting We can help you increase productivity by optimizing methodologies and finding ways to eliminate unnecessary and potentially time-consuming steps. AB Training Centers Fully staffed labs provide hands-on training and offer live, online training or self-paced software modules.

12 Performance, Throughput, and Confidence Applied Biosystems has been a leading innovator and trusted supplier of analytical solutions to the pharmaceutical and life science industries for over 25 years. We take great pride in the success of our customers, the quality of our systems, and the expertise of service and support personnel. When you purchase Applied Biosystems products, you re assured of professional support from one of the most respected companies in the industry. We offer each and every of our customers personalized service from knowledgeable professionals who are trained and dedicated to providing tools, information, and technical assistance required to achieve their process development goals. We are committed to continued innovation, striving to provide powerful, cutting-edge solutions that help biopharmaceutical companies drive process productivity to new levels. To learn more about Applied Biosystems systems for the biopharmaceutical industry, visit: info.appliedbiosystems.com/poros info.appliedbiosystems.com/services POROS is a Pharmaceutical Grade Reagent. For Manufacturing and Laboratory Use Only. For Research Use Only. Not for use in diagnostic procedures. Applera, Applied Biosystems, AB (design), Perfusion Chromatography and POROS are registered trademarks of Applera Corporation or its subsidiaries in the US and/or certain other countries. Amino Acid 20/20, AAA 20/20, Amino Acid 45/32, AAA 45/32 and MALDI TOF/TOF are trademarks and Analyst, MicroSeq, QTRAP and QSTAR are registered trademarks of Applied Biosystems/MDS SCIEX, a joint venture between Applera Corporation and MDS Inc. TaqMan is a registered trademark of Roche Molecular Systems, Inc. All other trademarks are the sole property of their respective owners Applera Corporation and MDS Inc. All Rights Reserved. Printed in the USA, 11/2007 Publication 121BR13-01 Headquarters 850 Lincoln Centre Drive Foster City, CA USA Phone Toll Free International Sales For our office locations please call the division headquarters or refer to our Web site at