Fast decisions instead of delays Quality Control through outstanding design

Transcription

1 Fast decisions instead of delays Quality Control through outstanding design

2 We are CustomBiotech from Roche In your operations, behind your decisions, powering your products You are driving a paradigm shift. Scientific and technological advances emerging from creative companies across the globe are transforming the way we look at disease and breaking down boundaries for treatment. The untapped potential in these innovations is accompanied by many challenges. How do you secure a supply chain in a global landscape? How do you ensure compliance in a demanding regulatory environment? How do you remain competitive in a fast-paced market? Now more than ever, business success hinges on finding suppliers, collaborators, and other partners who understand your needs and allow you to focus on what matters. What if all of those partners were one single ally a market leader with decades of experience in biotechnology and in vitro diagnostics standing shoulder to shoulder with your team? Welcome to Roche CustomBiotech.

3 Innovation Count on great ideas that work. From research and development to manufacturing and logistics, our experts and facilities cover an unparalleled spectrum of skills and technologies to explore any idea. Service Tackle problems with a smart ally. From business and regulatory issues to production troubleshooting, we help safeguard your operations and market standing with fast answers to problems, anytime and anywhere. Customization Invest time and resources into what you do best. For everything else, rely on us. With customized development, manufacturing, labeling, packaging and filling of components, we streamline the path of your product to market. Security Set your mind at ease. Our global reach, stringent standards and state-of-the-art manufacturing mean a secured supply of products and services to drive your business forward, when and where needed. Who we are 3

4 Fast decisions instead of delays Quality Control through outstanding design Better continuity and efficiency The complexity and stringent demands of pharmaceutical manufacturing today require quality control mechanisms that not only meet regulatory requirements, but also guarantee manufacturing continuity and efficiency. Conventional testing systems are time-consuming and cause expensive bottlenecks in production. For example, delayed product releases while waiting for test results lead to increased storage costs and potentially undetected contamination, which often makes it necessary to discard production batches. Strengthen your operational safety: In-house manufacturing of kit components guarantees highest quality and secure supply All-inclusive kit format eliminates time-consuming validation of single assay components ISO13485 conformant reagent production ensures consistent performance every time Assays compliant with regulatory specifications for manufacturing and release testing Kits can be validated on various analyzers and automated for high-throughput testing Fast and consistent QC solutions As one of the market leaders in diagnostics and pharmaceuticals, Roche is in a unique position to create and provide succesfull quality control solutions through outstanding design. Our detection assays emerge from the expertise and innovation of Roche Diagnostics and are then tested on the manufacturing floors of Roche Pharmaceuticals. The result of this interdisciplinary effort are validated, all-inclusive and highly efficient testing kits that meet stringent regulatory requirements and enable rapid quality assessments to safeguard your manufacturing processes. 4 QC solutions

5 QC solutions 5

6 Rapid Microbial Methods Designed and tested by Roche Detect cell culture contamination in hours, instead of days Bacterial and viral contamination of cell cultures can shut down manufacturing, destroy valuable cultures before symptoms of infection are visible, and compromise product safety. Release testing for mycoplasma is therefore required for several drugs, biologics, and medical devices, and frequent testing for Minute Virus of Mice (MVM) is highly recommended. The MycoTOOL Mycoplasma PCR Detection Kit and ViroTOOL MVM PCR Detection Kit are all-inclusive molecular tests with optimized controls and validated reagents for sensitive and reproducible quality control. Unlike culture-based methods, results take only a few hours, which minimizes the impact of possible contaminations. Regulators agree; Roche solutions meet authority requirements High test sensitivity, specificity, and speed are paramount for timely contamination management and essential to product safety assurance. For this reason, authorities in over 150 countries accept the MycoTOOL Mycoplasma PCR Detection Kit as a release test and many recommend PCR-based testing for MVM. The MycoTOOL and ViroTOOL kits require no sample pre-incubation, and the assays can be automated for high-throughput testing 1. Leverage our experience Use the MycoTOOL validation report from Roche Pharmaceuticals for guidance on how to easily incorporate the test into your quality control strategy Both MycoTOOL Kits (Endpoint and Real-time PCR) are compliant to EP and USP 63 Timely detection of cell culture contaminants in biopharmaceutical manufacturing Contaminant Sample type Sensitivity Specificity Kit format Time-to-result MycoTOOL Mycoplasma PCR Detection Kit >140 species of Mycoplasma (including uncultivable species) Various cell types (CHO, cell therapy samples, etc.) 10 CFU/ml for all species 1 CFU/ml for most species No cross-reactivity with closely related bacteria Endpoint and Real-time PCR -8 hours (Endpoint) <5 hours (Real-time) ViroTOOL MVM PCR Detection Kit Minute Virus of Mice Various cell types (CHO, cell therapy samples, etc.) 1 TCID50/ml No cross-reactivity with closely related viral species Real-time PCR <5 hours The assays can be automated for high-throughput testing 6 QC solutions

7 Ordering information Product MycoTOOL PCR Mycoplasma Detection Kit* (1 Kit for testing of 10 samples) consists of 2 subkits: MycoTOOL Mycoplasma Detection Prep Kit* MycoTOOL Mycoplasma Detection Amplification Kit* MycoTOOL Mycoplasma Real-Time PCR Kit* (160 PCR reactions) ViroTOOL MVM PCR Detection Kit* (30 PCR Reactions) MycoTOOL Carrier DNA MycoTOOL Mycoplasma Detection Prep Kit* (for use together with MycoTOOL Amp kit and/or RealTime Kit plus ViroTOOL and Residual DNA E. MagNA Pure 96 DNA and Viral NA Large Volume Kit (for use together with MycoTOOL RealTime and/or ViroTOOL) Catalog number Flexible throughput options for any need Prepare evaluation samples manually, but streamline batch testing with our high-throughput automated workflows. Product MagNA Pure 96 Instrument LightCycler 480 Instrument II Catalog number *Products are for use in quality control/manufacturing process only. The LightCycler 480 Instrument, the High Pure Kit, and the DNA and Viral NA Kit are for life science research only. Not for use in diagnostic procedures. QC solutions 7

8 Residual DNA detection Developed to meet requirements from authorities High sensitivity for product safety Removal of impurities from host cells is an imperative step in the production of biopharmaceuticals to guarantee product safety. Mandates from the World Health Organization and the U.S. Food and Drug Administration 2 require clearance of host cell DNA in final products, which must be confirmed via accurate testing 3. Based on proven real-time PCR technology, the Residual DNA CHO Kit and Residual DNA E. coli Kit provide the heightened sensitivity and broad detection range necessary to meet regulatory specifications. Simple and efficient integration into existing workflows Roche residual DNA kits are easily integrated into standing quality control procedures. Their performance is robust to sample type variation, including in-process samples and bulk drug substances, therefore the kits can be implemented at any stage in the manufacturing flow. Additionally, sample preparation requires minimal hands-on time and all necessary reagents and controls are included in the kit. This enables completion of the entire workflow in <5 hours 3, leading to faster product release, heightened sensitivity and broad detection range necessary to meet regulatory specifications. Detection of residual DNA from host cells used in biopharmaceutical manufacturing Target host cell Measurement range Linearity range Lower limit of quantitation Lower limit of detection Time-to-result Cross-reactivity Residual DNA CHO Kit Chinese Hamster Ovary cells 20 ng 2 fg per reaction 4 pg/ml 400 ng/ml 20 fg per reaction (4 pg/ml) 2 fg per reaction (0.4 pg/ml) <5 hours None to unrelated DNA Residual DNA E. coli Kit Escherichia coli cells 100 ng 10 fg per reaction 10 µg/ml 5 pg/ml 50 fg per reaction (5 mg/ml) 10 fg per reaction (1 pg/ml) <5 hours None to unrelated DNA Sensitivity requirements defined by WHO and FDA are met: 10 ng residual DNA per therapeutic dose 2. 8 QC solutions

9 Ordering information Product Residual DNA CHO Kit* (96 PCR reactions) Residual DNA E. coli Kit* (96 PCR reactions) High Pure Viral Nucleic Acid Kit (for use together with Residual DNA CHO Kit) MagNA Pure 96 DNA and Viral NA Large Volume Kit (for use together with MycoTOOL RealTime and/or ViroTOOL) Catalog number Automated protocols for Residual DNA E. coli and Residual DNA CHO are under construction. Flexible throughput options for any need Prepare evaluation samples manually, but streamline batch testing with our high-throughput automated workflows. Product MagNA Pure 96 Instrument LightCycler 480 Instrument II Catalog number *Products are for use in quality control/manufacturing process only. The LightCycler 480 Instrument, the High Pure Kit, and the DNA and Viral NA Kit are for life science research only. Not for use in diagnostic procedures. QC solutions 9

10 Residual protein detection Unique combination of enzyme plus QC test Activity- independent detection, more accurate control Enzymes used in biopharmaceutical and cell therapy manufacturing during cell preparation or for the modification and activation of products pose safety risks and must therefore be removed before final product release. Conventional methods used to ascertain the presence of enzymes are based on measuring enzyme activity, which fails to detect inactivated proteins that can still be immunogenic. To guarantee product safety, Roche has introduced high-performance kits based on ELISA technology to detect complete and fragmented enzymes, independent of activity. Complete manufacturing solutions The Residual Protein Liberase Kit and Residual Protein Trypsin Kit include high-affinity polyclonal antibodies that report the presence of enzymes with high sensitivity and in a broad range of sample matrices and types. Coupling these kits with Roche animal-free, GMP grade enzymes augments production efficiency, from the use of high-activity enzymes to timely verification of their clearance, and helps fulfill increasing regulatory requirements. Reliable detection of enzymes and enzyme fragments in process samples and final biopharmaceutical products Antigens detected Measuring range Lower limit of detection Time-to-result Convenient format Residual Protein Trypsin Kit Porcine trypsin and trypsin fragments ng/ml Trypsin 0.5 ng/ml hours All-inclusive kit with pre-coated plate Residual Protein Liberase Kit Collagenase I, collagenase II, thermolysin ng/ml Liberase 0.1 mg/ml hours All-inclusive kit with pre-coated plate Sensitivity requirements defined by WHO are met QC solutions

11 Ordering information Product Residual Protein Trypsin Kit* (96 reactions) Residual Protein Liberase Kit* (96 reactions) Trypsin, recombinant**, 3.5 mu per bottle Trypsin, recombinant**, 1 g Liberase MNP-S**, 35 mg Liberase MNP-S GMP Grade**, 5 mg Liberase MTF C/T GMP Grade**, 2 x 500 mg Catalog number *Products are for use in quality control/manufacturing process only. ** For further processing only. The LightCycler 480 Instrument, the High Pure Kit, and the DNA and Viral NA Kit are for life science research only. Not for use in diagnostic procedures. QC solutions 11

12 References 1) Roche Pharmaceuticals internal information 2) WHO Expert Committee on Biological Standardization. Fortyseventh Report. Geneva, World Health Organization, 1998, (WHO Technical Report Series, No. 878, annex 1), page 27 3) See instructions for use Regulatory disclaimer *Products are for use in quality control / manufacturing process only. ** For further processing only. The LightCycler 480 Instrument, the High Pure Kit, and the DNA and Viral NA Kit are for life science research only. Not for use in diagnostic procedures. Trademarks LIGHTCYCLER, MAGNA PURE, HIGH PURE, MYCOTOOL, VIROTOOL, and LIBERASE are trademarks of Roche. All other product names and trademarks are the property of their respective owners. custombiotech.roche.com Please contact your local CustomBiotech representative Europe, Middle East, Africa, Latin America Phone Fax mannheim.custombiotech@roche.com United States Phone , ext (toll-free) Fax custombiotech.ussales@roche.com Canada Phone Fax custombiotech.can@roche.com Japan Phone Fax japan.custombiotech@roche.com Asia Pacific Phone Fax apac.custombiotech@roche.com Published by Roche Diagnostics GmbH Sandhofer Straße Mannheim Germany 2016 Roche Diagnostics GmbH All rights reserved.