FEBRUARY 2017 YOUR FACILITY: FROM CONCEPT TO FIRST MARKET BATCH. AND BEYOND.

Transcription

1 Bio on demand TM achieve agile and flexible operations FEBRUARY 2017 YOUR FACILITY: FROM CONCEPT TO FIRST MARKET BATCH. AND BEYOND.

2 NEW PHARMA REALITY The world of pharmaceutical manufacturing is changing dramatically In addition to developments in globalisation, increasing GMP demands and price pressure, pharma companies also face challenges regarding flexibility, time-to-market and cost on a day-to-day operational level. Site agility: the key to your continued success In pharma operations your timelines are shrinking. The only way for you to succeed is to operate with maximum site agility and flexibility. Your facilities need to handle changes in production demands and quality regulations fast, and implement new knowledge and technology faster still. React. Rethink. Renew. THE GLOBAL DEMAND FOR AFFORDABLE DRUGS IS SOARING, PUTTING PRESSURE ON PHARMA AND BIOTECH COMPANIES TO RETHINK PRODUCTION. Build your market footprint with Bio on demand A new paradigm is needed MORE LOCATIONS: Companies are increasingly establishing local production capacity in an effort to maintain control over national healthcare priorities and to promote hightech development. FAST DECISIONS FAST ON THE MARKET Based on projections, cancer deaths will continue to rise with an estimated 9 million people dying from cancer in 2015, and 11.4 million dying in Through new and innovative products, the pharma and biotech industries make the world a healthier place. As the pharmaceutical industry evolves, it constantly develops new products, technologies and business practices all based on the commitment to improving the lives of people everywhere. At NNE, we focus on the pharma and biotech industries, and our mission is to contribute to a healthier world through the services we deliver to our customers. Through projects and consulting services, we have helped companies all over the world to bring products faster to market, decrease the overall cost of production and ensure patient safety. MORE PATIENTS: With growing wealth in emerging markets more countries and more patients will be able to afford treatments based on biotechnology. MORE COMPETITIORS: The advent of biosimilars in combination with advances in technology will to some extent open the market for more companies which will compete for shares of the market for existing products. And all have to adapt to changing market needs and market shares quickly. MORE TREATMENTS: The pipelines belonging to leading biotech companies as well as start-ups and newcomers are booming with new products and treatments. While a few traditional bluckbusters will still emerge, the vast majority of treatments are either targeted to a smaller group of patients or to more differentiated treatment of leading diseases, resulting in more variations in the products. The right response is to establish production capacity fast and often locally and to be able to restructure capacity to the changing needs. Fast decisions investment, cost of goods, time to market are quickly determined and site variations, capacity and flexibility requirements taken into account. REDUCED INVESTMENT Reduced Investment a flexible concept that allows you to make only net investments and wait with expansion until you have established your market position. Fast on the market we pick the fastest construction method for the location saving ½-1 year compared to other fasttrack approaches. MAXIMISED FUTURE OUTCOME Maximised future outcome flexibility allows you to change direction and introduce new products and new processes into the market. Bio on demand Bio on demand TM offers a fast, open and cost-effective way to optimise your future market position. We are with you from concept to your first market batch. And beyond. New Facility Oncology Infectious disease Cardiovascular Neuroscience Autoimmune 2000 l bioreactors Yield increase WHY? Decide to produce X kg of product Y in country Z. Investment order of magnitude can be determined in hours range: USD million. Solution is flexible do not get lost in details. WHAT? A flexible concept which covers a wide range of applications within a predictable timeline and budget and which take you all the way from concept to operation. You can create your own company standard and deploy it however you want, whereever you want. WHERE & HOW? Adaptation to company specific processes, policies and conditions Adaptation to local regulatory practices and supply situation NOW! The Bio on demand TM concept facilitates a location-specific implementation strategy. The solution is flexible towards exact technology choices, process vendors, compliance differences, etc months to first GMP batch BIO ON DEMAND Capacity: kg MAb API/year Net investment: USD million Solution: Tailored to location 8 WEEKS

3 In the new pharma reality, BIO flexibility ON DEMAND is a strategic advantage Since 2011, NNE has designed more than 20 Bio on demand facilities for top players in the pharma industry. These projects show that flexibility and open architecture provide a robust basis for meeting diverse demands in line with the trend towards smaller batch manufacturing. We complete projects within months on a regular basis At NNE, we address the need for fast project completion through an aggressive approach to fast-track work. Our goal is to execute any project within 12 months from project approval after basic design to finalising the operational qualification. Powerful from the beginning The future is now Being able to rapidly deploy biomanufacturing capacity will be a strategic asset in the future. Our Bio on demand TM facility concept offers a solution that allows you to move faster and provides you with clearer line of sight thanks to a high degree of standardisation. Designed for 200 kg MAb drug substance per year, the Bio on demand TM facility enables you to get your product to market fast and with full predictability. The initial capacity matches global demand for multiple products, but the same footprint allows for an increase to 400 kg per year by switching to larger capacity equipment. Hence, the standard can be a platform for four to five new product introductions in several markets. 4x1,000 litre bioreactors in upstream Upgradeable to 4x2,000 litre bioreactors From kg MAb drug substance per year The flexible nature of the facility also allows you to integrate new technologies in the future to further increasing capacity. RAPID DEPLOYMENT The standard manufacturing facilities for drug substance and drug product can be configured for local conditions in a matter of weeks and be ready for production in only months. Highlights Use existing buildings, science parks, brownfield or greenfield locations Freedom in construction methods and materials: Traditional, modular elements, modular buildings, etc. COMPANY SPECIFIC STANDARD The Bio on demand TM standard facility concept is designed for easy configuration to company specific requirements and local conditions. That means that you can create your own company specific standard facility, which can be deployed in a number of locations with only minor re-configuration for location specific conditions. Highlights Obtain your company-specific standard Establish new facilities with little or no re-configuration effort RISK MITIGATION Standardisation reduces risk and speeds up the facility project. Working from a facility standard sets a framework for configuration and allows us to focus on the aspects that are critical for the selected location. Once the configuration scope is defined, we apply proven project management methods to make the project a success. Highlights Work based on standards Reconfiguration for local conditions and requirements Proven project management methods for project realisation MAKE OR BUY Which functions do you include in your facility project? You may want to start with minimum investment and let functions such as buffer preparation, quality control and warehousing be partially or fully outsourced or handled in other facilities. Or you may want to harvest the advantage of having an integrated facility with all functions included at hand. A key decision factor in this is regard is your fill-finish strategy do you go for separate fill and finish, contract filling or a combination? SITE INTEGRATION Your site selection determines the extent of new utilities and site support functions such as lockers, social areas, canteen, clean utilities, black utilities and waste treatment. All of these may be present at your site. The bolt-on capabilities which is integrated in the Bio on demandtm concept allow fast estimation of the investment consequences of your site capabilities and conduces smooth integration. EXTENSION POSSIBILITIES Fill-finish Warehouse Weigh dispense Media and buffers Black utilities QC laboratory R&D laboratory PD pilot plant Clinical pilot plant Drug conjugation Administration Reception OVERVIEW API drug substance facility The standard drug substance facility addresses the need for flexible bioprocessing facilities which can be deployed rapidly to meet local market demands. The facility contains the bioprocessing core and all needed clean utilities. It is based on single-use technology to simplify installations, reduce investments and minimise operation costs. The standard can be adjusted for greenfield, brownfield or existing building conditions. The maximum annual output can meet demand for four to five product introductions depending on the market. Support functions such as quality control laboratories and warehouse can be integrated into the standard design, which can also be combined with the drug product facility from the beginning or in the future. FACTS The facility design is adaptable for local conditions and regulations. Standard is based on one floor layout, designed for vertical integration. The standard design can integrate QClaboratory, warehouse, drug product formulation and filling FACTS Capacity 200 kg MAb drug substance per year based on 3 g pr/l Upgradeable to 400 kg/year Technology 4x1,000 litres single-use bioreactors scale Upgradeable to 4x2000 litres within same footprint Price USD million Time months Area 1,500 m 2 Footprint 1,500 m 2 and up, adaptable Cost of goods USD /MAb drug substance Options Drug product Quality control laboratory Administration, reception Canteen, Warehouse Energy centre OVERVIEW Final drug product addition The standard drug product facility addition appends final product formulation and filling capability to the standard drug Substance facility. The combination creates an integrated primary and secondary bioprocessing facility for those locations where drug product processing capacity is not available otherwise. The drug product addition is designed to match the annual output of drug substance and can be integrated as a vertical or horizontal addition. Quality control laboratory, warehouse and black utilities can be included for a stand-alone greenfield facility with full production capability. FACTS The facility is adaptable for local conditions and regulations Footprint accepts any combination of US and EU regulation as well as RABS and isolator technologies The standard is designed for liquid filled vials and lyophilisation. The facility can be expanded for pre-filled syringes DATA Capacity 200,000-1,500,000 doses per year dependent on product mix Formulations Liquid vials Lyophilised vials Pre-filled syringes as option Price USD million Time months Area 750 m 2 Footprint 750 m 2 Cost of goods USD 10-50/dose MAb drug product Options Inspection Label and packaging Isolator technology Pre-filled syringes Ready to fill systems Serialisation Devices

4 Reduce investment cost and increase flexibility with single-use technology The Bio on demand concept is based on configuration with single-use technology process equipment to reduce investment cost and provide strategic flexibility. Other advantages include faster scalability and tech transfer and lower contamination risk. Continuous processing enables more costeffective processes and high productivity One of the new topics in focus in pharma manufacturing is continuous manufacturing, but very few pharma companies have tried it on a commercial scale. This type of manufacturing, however, clearly shows a level of manufacturing productivity that no other technology can provide. Fit to purpose WASH & STERILISATION Open for evolution CELL CULTURE SEED LAB IPC LAB The flexible approach of Bio on demand TM matches the rapid pace of development in the biopharmaceutical industry. The inherent, high flexibility opens the way for optimising process and operations in a variety of ways: MEDIA PREP DISPENSE WASTE CONTROL FINAL PURIFICATION NEW OPERATING PARADIGM NEW SUPPLY CHAIN LANDSCAPE NEW TECHNOLOGIES NEW PROCESS STEP DESIGN Your Bio on demand TM facility is customised to meet your technical, operational and regulatory requirements. We work closely with you to configure the standard facility to your specific process and facility situation based on a library of standard functional modules. The standard is designed for next generation bioprocessing with the following design drivers in mind: Open process architecture The standard facility is designed for an open process architecture, where process equipment from the full range of suppliers can be used to build the optimal process train. This flexibility is reflected in ample space for processing operations, reserved workflow routes and readiness for room classification changes. Install and switch process equipment as needed Work with equipment and consumables from all suppliers. Dual supplier strategies. Optimise process and economics independent of proprietary hardware and software solutions MULTIPRODUCT FACILITY: Fast changeover Next generation bioprocessing requires multiproduct capability to accommodate larger product portfolios. The Bio on demand TM standard facility is designed for campaign mode multiproduct processing. Areas that may include open processing steps are segregated by default. Productivity is maintained by providing areas for parallel operations in order to accelerate changeover. Up to three products in process at the same time Two seed laboratory functions for smooth transfer to next upstream product Controlled solid waste flow to speed up room clearance before next product Full facility lifecycle The standard facility design can afford clinical, launch and market supply stages: The upstream area is high-ceilinged leaving room for larger bioreactors. Downstream and buffer sections are large enough to allow for installing of larger capacity equipment or for increasing the number of process step cycles. STORAGE BUFFER PREP Clinical: Start with 200 or 500 litre bioreactors and full single-use purification process Launch plant: Install more bioreactors or increase to 1,000 litre bioreactors Market supply: Change to 2,000 liter bioreactors and install higher capacity purification equipment. Process bay design The process areas are designed for a 100% flexible platform based on single-use technology and small to medium scale processing. Process bays provide floor area and utilities for all typical bioprocessing steps. With no fixed installations, the latest and best process technologies can be introduced quickly. Process bay design with generalised utilities provisions Extra process bays for additional process steps Quickly re-arrange process step sequences or process in parallel Area = Flexibility Selected area allocations provide flexibility for future process changes. Areas are designed for adding or exchanging equipment to set up the optimal process configuration. Reserved workflow routes for transport of harvest and process PURIFICATION pools double as pathways for exchanging consumables and rearranging equipment. Build media and buffer supply configurations as needed Reserved workflow routes for transport of solutions Large buffer volumes by parallel storage or dilution of concentrated buffers Optimal ergonomics and workflow The standard facility provides optimal ergonomics by placing large solution volumes near points of use - there is no need to move these volumes around. The design foresees the need for space around equipment and doorways for safe transportation and manipulation. Process flow is uni-directional from vial to process bulk and solutions flow is perpendicular to the process. Short transportation routes for raw materials and solutions Larger media and buffer volumes can stay in place, no need to move around Space for safe and unobstructed manipulation of tubing and single-use bags Continuous processing offers increased productivity from better equipment utilisation. New continuous approaches that circumvent the need for batch processing to regenerate downstream steps are starting to emerge. Advantages include: Markedly reduced cost of goods manufactured Increased productivity from improved equipment utilisation Constant process characteristics during continuous phase Reduced equipment dimensions and cost Technology flexibility (approved suppliers) 3M Adventapure ASI ATMI Bausch & Strobel Bosch Carr Cellution Cercell Charter Crystal Colder Finesse Flexicon G-CON GEA Lyophil GE Healthcare Grace Groniger Hof Sonderanlagenbau Hyclone The supply chain is an obvious subject for optimisation due to the high correlation with operational flexibility, strategy opportunities and facility running costs. Although technology maturation is taking place, standardisation is not widespread and second supplier strategies can be a challenge. But the landscape is changing rapidly, and new players, alliances and technologies are emerging. When optimising your supply chain strategy, the following factors are relevant to take into account: First Chinese suppliers of bioprocess purification media and single-use bags Second wave process equipment designed for single-use bags from several suppliers Leverage purchasing power as large consumer Second supplier strategy IMA LIFE Freeze Drying Solutions JM Separations Lauda Lewa Merck Millipore Meissner NovaSep Pall Pendotech Plannova Technologies to further increase bioprocessing output continue to arrive at the scene from many suppliers and at a rapid pace. Some high impact examples are: High density cell culture retention devices to maximise batch output Dual-step equipment covering several process steps to reduce installed equipment base Single-use filling technology to reduce cleaning and sterilisation efforts, also in secondary production High capacity, true single-use cross flow membrane technologies QuattroFlow Refine Repligen Sartorius Schulte Shanghai Tofflon Science and Technology Spectrum Thermo Fischer Xcellerex Process focus has changed as a result of a general move towards platform processes. This change goes hand in hand with Quality by Design approaches which paves the way for optimisation of process steps. Improvements can influence many different aspects including impurity profiles, operator shift patterns, buffer consumption, change-over times and installation costs. Such advantages can be derived from process step optimisation based on: High capacity purification media Virus clearance technologies based on UV or heat treatment Membrane chromatography technology, several possibilities for cost and throughput Dual effect membranes in depth filtration, improving impurity profile as well as clarification Biomanufacturing yields increased times over the last decade. And the future will bring many technology and process opportunities to increase productivity further. Facilities with open process architecture that freely can assimilate optimisation will become a key competitive parameter. Niels Guldager, senior technology partner, biopharmaceuticals, NNE

5 A successful technology transfer has the end goal in mind from the beginning Emerging markets represents the major growth engine of the global pharmaceutical industry with a high unmet demand and very little local manufacturing. To unlock this huge potential, you ll have to look at the enablers and critical points in technology transfer. Modular engineering equals fast-track projects, easy reuse and high flexibility Establishing the right capacity in the right time is crucial, and one way to achieve this is to use a modular approach, where facility design is broken down into logical modules. This enables parallel activities, giving the project additional flexibility and making project changes more feasible. License to operate Construction to fit The Bio on demand TM facility is based on a configured-to-order idea: Though based on a high degree of standardisation, it is adaptable to customer specific needs, national and local requirements, site specific conditions as well as international regulations. No matter where in the world you choose to build your Bio on demand TM facility, we have the required capabilities to guarantee you your license to operate. FINDING WAY THROUGH THE JUNGLE OF RULES In pharmemerging markets particularly, it can be next to impossible to make head or tail in the complex approval process that is part of setting up business. Often, it requires contact and negotiations with several national and local state authorities to obtain the necessary approvals. Navigating the bureaucracy can thus be a lengthy and exhausting affair, which may with much advantage be left to us. Due to our local presence, NNE knows the ins and outs of the pharmerging markets and business environments and can guide you through the jungle of local rules and requirements. We can also assist you in communicating with relevant authorities in order to make the process of setting up business smooth and problem free. HANDLING CUSTOMS, TAXES AND WORKFORCE Critical process equipment may need to be imported to many future markets because technology of sufficient quality is not available locally. Likewise, you may also have to import raw materials and consumables. Local workforce requirements and competence levels also vary from country to country. NNE s knowledge of local conditions allows us to make realistic business case assessments covering time, investment cost, operating cost and personnel by adjusting for these factors. BENEFITTING BY AVAILABLE TECHNOLOGY Regardless of where you choose to place your new facility, sourcing from low cost countries can be profitable. But it can also be risky. NNE has a network of 8,000 prequalified gobal technology suppliers, which we have worked with for several years. In combination with our procurement power, this list can offer much help in faciilitating your project - whether NNE Pharnaplan is executing it or not. MAKING THE MOST OF YOUR NEW SITE For your new site to become a success it is essential to develop an overall strategy for it s physical development. A wealth of factors are relevant in this context; from your company vision and values through infrastructure and social areas to environmental issues and architectural considerations. We have specialists at our disposal for each of these areas and can help you draft a site master plan which clarifies in detail how the site should be developed and adapted in order to maximise it. ENSURING GMP COMPLIANCE Regardless of your ambiition level and starting point, NNE can help you achieve compliance with local and international GMP standards. Our Bio on demand TM concept allows us to adapt the building modules for your facility to local GMP requirements based on a bio-manufacturing function library. SELECTING THE RIGHT BUILDING METHOD Bio on demand TM provides total freedom in construction methods. If you are unsure which method is the right one for you, NNE can provide expert consulting to help you build a business case for each scenario. This will give you a solid basis for decision. On the opposite page we provide an explanation of our overall construction concept and the three different building methods we operate with. DRIVERS To identify the optimal deployment method, we evaluate a range of factors against the overall business strategy, for example: Cost Time schedule Need for high flexibility to facilitate changes and expansions Architectural impression Need for flexibility in loads, ceiling heights, free spans Strategic choices for local suppliers, contractors and materials to optimise building costs Support functions already available on site Degree of site preparations needed Accessibility of construction site Site constraints like maximum footprints, allowable ceiling heights Permitting and environmental roadmap Geographic factors: Hurricanes, earthquakes, snow fall, water levels, etc. Availability of local construction workforce ON-SITE CONSTRUCTION On-site construction offers the highest degree of flexibility and ability to shape your facility. This method offers few limitations in ceiling height, floor loads, number of levels and even structural spans. A variety of construction materials can be used, e.g. variations of steel or concrete structures. The building is erected quickly the concrete structure averages three weeks per building level once the foundation is established. Subsequently, HVAC and cleanroom modules are integrated. INTEGRATE INTO EXISTING BUILDING Converting an existing building space is often the fastest and most cost-effective route to biomanufacturing capacity. Significant reductions in timeline can be achieved because foundations and permissions are already in place. As the roof and climate shell is also established - at least partially - we also benefit from independency of weather and seasons and are thereby able to work in multiple sections of the facility simultaneously. But converting an exsiting building may not be without hurdles because of interdependency of systems and possible contamination from prior processes. BIO ON DEMAND OFF-SITE CONSTRUCTION FASTER AND SAFER Construction off site or even at site (at a location close to the facility site) reduces dependence on initial site conditions. This approach can speed up operations if, for instance, the permission process is lengthy or the construction site needs to be cleared or prepared before on-site construction can be commenced. This can offset the time needed to transport the modules to site. Candidates for off-site construction range from piping systems and process skids up to entire building modules with equipment included. Tolerances are in milimetres and on-site construction is reduced to a number of days because the modules arrive pre-tested. DEPLOYMENT FLEXIBILITY According to IMS Health, the 17 markets highlighted in red contributed with 48 percent of annual market growth in Many of these countries have regulated economies where market access is dependent on establishing local biomanufacturing capacity. Bio on demand TM is targeted to meet these business conditions.

6 Flexible and reliable facility projects - anywhere in the world When we deliver facility projects, we work based on a global engineering model, Our Model. This model ensures that everyone on our projects works with the same well-proven methods and best practices worldwide, and they are flexible enough to adapt to yours. End-to-end support from consultants specialised in pharma Our pharma consultants are with you all the way from project idea through project execution to ramp-up and beyond. Through focused pharma engineering we help you obtain and maintain an optimal production so you can always deliver on demand. Your first market batch. And beyond. When executing a project, NNE s overall objective is that our customer develops new capabilities and grows existing ones. Focusing on capabilities rather than technical project or programme outcome is key to accomplishing expected benefits and contributing to the strategic objectives and visions. Key components for your roadmap Based on a decade of biotech and single-use project experience, we have built a selection of activities that are key components in the roadmap for next generation facilities. The activities can be performed as stand-alone or project-integrated services, but always on a customer-oriented basis. Drug substance facility Drug product facility Pilot plant Filling and freeze drying Medical devices Batch documentation SOPs Single-use environmental impact assessment Process validation Design reviews Automation part 11 compliance check Single-use technology due dilligence Automation strategy ASTM E2500 approach Virus clearance validation Process debottlenecking Downstream flexibility Facility startup programme Professional process user team augmentation Business case Cost of goods manufactured Process technology selection Leachables and extractables risk based approach Site selection Local supplier selection Activities Bio on demand configuration Months SOPs Basic design Detailed design Permits building Training Building construction WHY? WHAT? Modules utilities construction Utility installation Modules process construction Supply chain optimisation Process installation Verification (Qualification) Operators training Cost of goods manufactured optimisation Tech transfer Performance qualification WHERE & HOW? 8 WEEKS NOW! Engineering batches Environmental monitoring Process validation First GMP batch 18 months to start first GMP batch Continued process validation New product introduction SITE PROCUREMENT QUALITY SYSTEM PROCEDURES SUPPLY CHAIN MANUFACTURING TRAINING TECH TRANSFER LICENSING COMPLIANCE OPTIMISATION Site selection Site evaluation Permitting Environmental impact assessment Supplier qualification Supplier selection Contract negotiations Customs and taxes Business ethics Quality system design Quality organisation Qualified persons SOP-system Validation strategy Self-audit Gowning Manufacturing Batch release Deviation handling Change control Training Due diligence Quality agreements Sourcing of consumables and raw materials Supplier audits Contract negotiations Alternate supplier strategy Master formulae Batch documentation Start-up planning SOPs Process validation Start-up team augmentation Information systems: LIMS, etc. Maintenance system Training programme design Operator training GMP training QbD training Training documentation Tech transfer governance and planning Due dilligence Facility fit New equipment specification Modifications and installation Batch documentation SOPs Engineering runs Process validation Control strategy Common technical dossier Mock audit Pre-approval inspection preparation Pre-approval inspection support and response cgmp Compliance check Annual review Continuos process validation Continuous improvement programme Lean OEE Six Sigma

7 It s a new bio world OPTIMISE YOUR MARKET POSITION WITH BIO ON DEMAND Copenhagen Kalundborg Hillerød Brussels Frankfurt (Bad Homburg) Chartres Paris Lyon Tianjin Basel San Francisco (Emeryville) (TEDA) Montreux Morrisville Shanghai (Research Triangle Park) Bangalore Offices Project references Single-use MAb / biotech projects Discussions initiated NNE Biotech Center Niels Guldager is Global Technology Partner for biopharmaceuticals at NNE. He heads the company s biopharmaceutical design group and development initiatives. Niels started his carrier in 1992 as production engineer responsible for upstream production of recombinant human insulin and technology transfer for next generation products. Later he moved on to downstream manufacturing. Niels is a globally leading expert in single-use technology and Quality by Design impact on process and facility design. He is engaged in single-use technology community work for industry organisations PDA and ISPE. He is also a member of PDA s task force for gene and cell based therapies and holds the Certified Pharmaceutical Industry Professional certification from ISPE. Mobile phone: Morten Munk is a Global Technology Partner at NNE with more than 25 years of industry experience in biopharmaceutical development and manufacturing and is a globally recognised technical expert in the field. He has authored or co-authored a number of technical articles an d guidelines. In addition, he is active in international industry organisations, including ISPE and PDA, where he has formed part of the scientific committee for various international conferences. Mobile phone: Kang Wei has 20 years of work experience in the pharmaceutical and biotechnology industry. He has led several projects and coordinates the quality and scheduling of projects. One of his core competences is front-end engineering within biotech bulk, and inished product, with emphasis on pharmaceutical processes, GMP compliance and validation. Mobile phone: NNE is an international company specialised in pharma engineering. We help pharmaceutical companies bring products to market by providing flexible, compliant and future-proof solutions. We have close to 2,000 professionals delivering global knowledge and best practices, all dedicated to supporting our customers globally and on local sites. Through focused pharma engineering we enable our customers to deliver on demand. To learn more about our company, please visit our website nne.com