Recommended
Recommended
More Related Content
What's hot
What's hot (20)
Similar to Bio Summit
Similar to Bio Summit (20)
Bio Summit
- 1. The Premier Global Service Provider For Microbial Identification 1 Confidential
- 2. Accugenix Our Value Proposition Confidential 2
- 3. Confidential 3 Your Global Solution for Microbial Identification Testing
- 5. Safety
- 6. Risk Mgt.
- 9. Supply Chain Recalls
- 10. Regulatory
- 12. Investor Confidence
- 14. Brand ImageConfidential 4
- 15. Managing Risk Regulatory inspectors are more aggressive Manufacturing processes are a series of steps which are interlinked and independent All processes have variability Quality goal is to understand and reduce variation Inaccurate and inconsistent microbial ID's can lead to false state of control and remediation actions Confidential 5
- 16. Intangible Benefits of An Identification Program for the Business Driver Accuracy & Reliability of ID Method Tracking & Trending Knowledge of Frequently Occurring Organisms State of Environmental Control of Manufacturing Area Shifts in Recovered Organisms Operational Benefit Early Detection/ Remediation Base Decisions on Risk Factors Reduce Inventory Losses Avoid or Reduce Plant Shutdowns Save Money FDA Warnings Brand Image Confidential 6
- 17. Think Lean - Micro QC ActivitiesHow much time & resources do you spend? Airborne viable contaminants Surface contaminants walls equipment surfaces countertops Floors Water Personnel contaminants Endotoxin Sterilization BioBurden Media fills Microbiological monitoring of the environment Identification Instrument QA Tracking & Trending EM limits & Excursions Investigations Corrective actions Validations Documentation Procedures Gridding locations Aseptic training Confidential 7
- 18. Brand Protection Quality We specialize in Microbial Identification and Characterization of Environmental Isolates. Our labs are cGMP complaint – FDA inspected; meeting all EU requirements Our proprietary solutions yield confidence with a greater than 98% accuracy rate. We have service laboratories in the U.S. and Europe to enable method standardization across multiple manufacturing sites. Cost Reduction More affordable cost/identification than comparable in-house or outsourcing test methods. Our volume capacity yields greater savings to our customers. Large volume corporate discounts are available. Service Excellence We have a staff of dedicated Microbial and Phylogeneticist Scientist are available to provide the answers to all of your inquiries. We offer flexible TATs to meet your requirements whether it is a routine test or critical event under investigation. We offer multiple convenient sample prep methods for shipping that can further reduce your costs. Process Improvements We can track and trend organisms identified in your manufacturing environment to help you manage risk and enhance the critical data about your production facility. Our validated proprietary library are the largest and most relevant in the industry.
- 19. Accugenix Challenge Will Match Quality ----- Beat Your Cost Confidential 9
- 20. Accugenix Service Offerings Quality AccuGENX-ID Sequencing 98% Reported out 0.2% Error rate Proprietary Services AccuGENX-ID™ AccuPRO-ID™ AccugenixMALDI - TOF 98% Reported out 2% Error rate MicroSEQ® Sequencing 85% Reported out 10% Error rate “Out of the Box” Services ABI Bruker bioMérieux BioTyper MALDI-TOF 72% Reported out 2% Error rate VITEK® 2 Compact 73% Reported out 20% Error rate
- 21. Microbial Identification Methods Accuracy & Reproducibility Accugenix-Applied BioSystems Sequencing Genotypic DNA RNA Proteotypic Accugenix- AccuPRO-ID™ Bruker BioTracker Protein Expression Phenotypic VITEK ® 2 Compact Catalase Fatty Acid Fermentation Gram Stain 11 Confidential
Editor's Notes
- Our stake holders look for 4 value propositions when considering a vendor. This slides speaks to the drivers behind Technology, Service, Quality and Cost that Accugenix delivers.Quality – FDA approved Germany & US follow same procedures & processes Unblemished audit record Cost – Because of our volume we will beat cost/sample of any in-house out of box system Standardize your ID program across facilities Benefit of having two locations to ship your samples 4 Tier pricing program based on volume of samples, method selection and data analysis to meet your need for price point and quality of results Technology – Foundation of our value is the library for sequencing Over 2,800 entries Specialization in ID’s for sterile and aseptic manufacturing Competition focuses on Clinical Diagnostic market Highest Quality & ability to differentiate to species level Dynamic vs Static Library updates Service – Flexible TAT to meet customer needs Same day to 10 days Shipping samples is easy, plates, Ethanol extracts, FTA cards, DNA extractions
- An effective EM program adds intangible benefits to all the stakeholders at different levels.These 4 areas are top level EM benefits.
- Focus is on bullet #5. Although ID are only a piece of the overall production/quality management system it is a major component in product safety, product flow, supply chain and brand image. Accurate ID’s provide better data to make informed decisions to manage risk factors with regard to alerts, excursions and recalls.
- The left column represents the tactical drives behind an effective QC Micro Program. This is the information/data they need to have in order to determine the “State of Control” .The right column represents the intangible operational benefits they can achieve for the business by using the “Best in Class” ID service.Our services offer a greater ROI in their investment than just cost per sample comparisons.
- Do more with less attitude! The list represents functional responsibilities with a QA/QC Micro organization.Appeal to the prospect of outsourcing ID’s so that the time and resources required to perform ID’scan be diverted to these other functions. Outsourcing ID’s doesn’t necessarily mean job reduction, but greater efficiency to perform these other duties.
- This challenge starts a discussion on 4 tiered pricing.Matching the quality of any in source solution and beating their true cost/sample result.
- Prices are average selling prices.Price vary depending on TAT and volume discounts for Accugenix.
- Genotypic uses 16S rRNA for sequencing has the highest degree of accuracy & reproducibilityProteotypic uses MALDI-TOF technology, capturing a ribosomal spectra which is equivalent to a fingerprint Phenotypic methods test for biochemical expressions. Proteotypic off the shelf is in the middle in terms of performance, but Accugenix has brought it to Genotypic level.If we are unable to achieve an identification with MALDI-TOF because on a missing entry in the database, we offer free sequencing at no additional charge. Emphasize that we are committed to growing the MALDI-TOF library, as we have done with sequencing. This is the growing pains of innovated new products, but we have a dedicated program for library growth as we will show latter on in the program.