custom solutions With markets changing so rapidly, AMRESCO is on the front line bringing new technologies and processes so we can deliver solutions that solve our customers problems.
TESTIMONIAL: Congratulations! Our company s EID Incoming Inspection of AMRESCO-provided products will be waived. This is a direct result of your commitment to providing a superior quality product, as indicated by our inspection data. It also affirms our high level of confidence in AMRESCO S ability to continue providing 100% conforming products. We recognize the effort that went into attaining this status and appreciate your continued commitment to excellence on our behalf.
High Purity Chemicals pure QUALITY IN ACTION MAJOR PRODUCT GROUPS Agaroses & Acrylamides Amino Acids Antibiotics Antimycotics Biological Compounds Buffers Carbohydrates Chaotrophic Agents Chelating Agents Detergents Dyes/Stains Enzymes Media Phenols/Organics Preservatives Reagents Reducing Agents Salts Substrates Sugars AMRESCO is one of the world s leading manufacturers of fine chemicals, biochemicals and reagents, distributed directly under the AMRESCO brand or private labeled for large global leaders. Purity is our priority, and AMRESCO assures that the highest industry standards are achieved through rigorous ISO standards and FDA regulation. Cost and material efficiency is essential in achieving competitive advantage in today s challenging market. That s why we provide our products in the exact quantity, formulation, grades and packaging our customers need and want. INDUSTRY INSIGHTS WE HEAR THAT... With new life science market opportunity comes increased risk and regulation. Whether supplying enterprising new start-ups or large international manufacturers, quality is paramount, along with the ability to provide all relevant documentation. Customers tell us they need a provider with expansive product knowledge and flexibility in formulation, packaging, logistics and competitive pricing. Extensive depth in our raw material supply chain assures quality, traceability and on time delivery AMRESCO S Product Design Group consults with customers for custom formulations, testing and validation methods solutions Profitability and operation efficiency is achieved through custom packaging and inventory management. 1.800.448.4442 371
Custom Specialty Manufacturing precise INNOVATION IN FOCUS With rapid advancements and changes in the life sciences markets, AMRESCO s ongoing investment in advanced precision manufacturing technology positions us well to meet our customers complex production requirements. So does the investment in our human capital our people. We work expertly and efficiently on behalf of our customers and mutually share in their success. From start-ups to multi-national corporations, we look to bring value in the way that benefits each customer best. INDUSTRY INSIGHTS WE HEAR THAT... Life science companies today need partners with operational flexibility coupled with uncompromising and consistent quality. With growth and profitability concerns, companies are evaluating internal limitations and looking to forge strong service partnerships to increase capacity, reduce hazardous material handling, contain cost, expand market opportunity and conserve capital. AMRESCO is structured to deliver comprehensive scalability and customization for production, packaging and deliverability Our experienced project management and production teams can provide product development and co-development support or manufacture according to customer specifications AMRESCO S capital investment in infrastructure, technology and capabilities, along with continual process improvement, is designed to keep us moving in line with and ahead of market needs CUSTOM SERVICES Custom Contract Manufacturing OEM Manufacturing Liquid Manufacturing Powder Manufacturing Specialty Manufacturing Product Design & Development Custom Packaging Label Control & Management Hazardous Material Production Handling & Transportation Validation & Qualification Expertise Regulatory Expertise & Alignment 372 www.amresco-inc.com
Manufacturing Services CUSTOM MANUFACTURING OEM Manufacturing FDA QSR Compliant Facilities Custom Protocols & Specifications Lean Production Processes & Principles Scale-Up from Bench Scale to Large Lot Sizes Ability to Manufacture Complex Materials Formulation Development & Execution Environmentally Controlled Facilities Segregated Facilities for Sensitive Products SPECIALTY MANUFACTURING Tableting Lyophilization Recrystallization Slurry, Emulsion & Viscous Material Handling Dye Liquid & Powder Compounding Gamma Irradiation & Autoclave Sterilization Specialty Filtration Processes Molecular Material Handling Dye Handling & Compounding LIQUID MANUFACTURING Scalable Lot Sizes: Bench Scale to Thousands of Liters Per Lot Sensitive Materials Requiring Environmental Controls RNase, DNase & Protease Free Reagents Low Endotoxin Reagents Aseptic Reagents Precision & Tight Tolerance Requirements Molecular Materials-RNA, DNA, Proteins Enzyme & Active Ingredient Reagents Hazardous Materials & Reagents pricing and discounts. POWDER MANUFACTURING Scalable Lot Sizes: Bench Scale to Metric Tons Complex Multi-Component Compounding Homogenous Complex Blends Sensitive Materials Requiring Environmental Controls Segregated Handling for Non-Animal Origin Antibiotics Hygroscopic Materials Particle Size Control / Exclusion Particle Size Reduction / Milling Low Endotoxin Products Hazardous Product Handling Dye Handling & Compounding 1.800.448.4442 373
Strategic Services performance POSSIBILITIES DELIVERED A promise is a promise is a promise. It s performance that delivers on a promise that is the measure of success. Performance driven by deep industry knowledge and a strong extensive track record over time. More and more, companies are turning to AMRESCO for solutions to their challenges, including infrastructure support, risk mitigation, start-up or enterprise support, profitability and growth initiatives. They need a partner that stands with them and they want success. We want that, too. INDUSTRY INSIGHTS WE HEAR THAT... Increasing market pressures are challenging life sciences companies to address infrastructure inefficiencies, production capacity, logistics and inventory management, as well as mitigate tax and insurance implications, meet compliance and quality standards, maintain competitive advantage, compress critical time to market performance and a growing host of critical considerations. STRATEGIC SERVICES Inventory Management Cost Improvements Product Transition and Integration Capacity Management Global Logistics Supply Chain Management Pack and Hold Options Process Improvement Warehousing Drop Shipment Capabilities Label Control and Management Documentation Our Product Design and Engineering Team works closely with each customer to develop the unique design and production programs that help them focus on the future, not production limitations. Our Strategic Services Team are specialists at assessing operational and process inefficiencies, providing invaluable support and expertise in increasing performance, service and profitability. 374 www.amresco-inc.com
Custom Packaging and Dosing Capabilities CUSTOM PACKAGING & DOSING CAPABILITIES Private Label / OEM Packaging Expertise Reduce Lot Tails with Custom Raw Material Packs Customer Packaging Scale-Up from Small to Large Lot Sizes Automated Production Processes Environmentally Controlled Capabilities Segregated Facilities for Sensitive Products: Antibiotics Non-Animal Origin Materials Hazardous Materials Hygroscopic Materials Light Sensitive Materials FLEXIBILITY IN PACKAGING TYPES Bottles Drums Pails Vials Ampoules Tablet Strip Packing Pouches Bladder Bags/Totes Serum Vials & Stoppers Kits Unique Custom Packaging POWDER PACKAGING Precision Powder Dosing Milligram Quantities Humidity Controlled Handling Light Sensitive Material Handling Handling under Inert Gas High Throughput, Semi-automated Powder Dosing LIQUID PACKAGING Precision Liquid Dosing Microliter to Hundreds of Liters Unit Quantities High Throughput, Automated Liquid Dosing Aseptic Dosing Sterile Processing to USP Sterile Levels Tight Tolerance Dosing KIT ASSEMBLY Complete Traceability of Kit Components Flexibility & Customization in Kit Configuration Full Supply Chain Management Order Placement and Receiving 1.800.448.4442 375
Supply Chain Management LABEL CONTROL AND MANAGEMENT Inventory of Label Stock Printing Capabilities Label Security & Reconciliation Flexible Label Styles, Shapes Customer Specific Labels LOGISTICS Worldwide Distribution Expertise Hazardous Material Shipping Expertise Temperature Sensitive Material Capabilities Drop Shipment Capabilities Certified & Trained Logistics Documentation Capabilities FULL SUPPLY CHAIN MANAGEMENT Reduce Material Receipt Cycle Times Maximize Warehouse Volumes Reduce On-Hand Inventory Pack & Hold Options Raw Material Procurement & Management Robust Supply Chain Management Includes Validated Secondary & Tertiary Supplies Lot Reserve Minimize Sampling of Batches & Incoming Inspection Drop Shipment Capabilities CASE STUDY THE VALUE OF RELATIONSHIP Trust takes time, along with performance, understanding and alignment. For several years, AMRESCO had called on this leading molecular diagnostic company and when their contract manufacturer did not pass the customer s audit, their upcoming product launch became a crisis. They needed a partner, one with advanced capabilities, supported by strong team relationships. AMRESCO moved through validation, then integration of its new aseptic precision automation system into the manufacturing process. We were also able to reduce their supplier base, manage their supply chain and provide them the freedom to focus on issues core to their platforms. 376 www.amresco-inc.com
Regulatory & Quality Systems Trust and performance are the key decision points for companies looking for their outsourcing partner. Quality is essential, as is uncompromised deliverability and repeatability. Documentation, labeling, testing and supply chain exposure assessment and management mitigates critical regulatory and compliance issues. Outsourcing quality control, certification and testing provides greater assurance in validations and audits. REGULATORY ALIGNMENT ISO 9001 Certified with Design Control ISO 13485 Certified with Design Control FDA QSR Compliant Facilities, Processes & Documentation FDA registered as a manufacturer of In Vitro Diagnostics and handler of pharmaceutical intermediates QUALITY MANAGEMENT SYSTEM Full Traceability Change Control FDA Level Document Control Environmentally Monitored Production Processes Environmentally Controlled Production & Warehouse Facilities Method, Product, Process Validation Corrective & Preventive Action System Continual Improvement System Non-Animal Origin (NAO) Control ANALYTICAL & CUSTOM QUALITY CONTROL SPECIFICATIONS Multi-compendial Testing Material Certification Sensitive Analytical Testing Chromatography ICP FTIR Titration Spectrophotometric Testing Bioburden Testing Endotoxin Testing Custom Functional & Performance Assays Material Origin Control Full Lot Traceability Products Tested & Retained 1.800.448.4442 377