NNE Pharmaplan company presentation

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Our company presentation contains information about our company, our competences and our experiences.

Our company presentation contains information about our company, our competences and our experiences.

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  • The pharmaceutical and biotech industries are based on and driven by new ideas. As the industries evolve, they constantly develop new products, technologies and business practices.We take pride in staying on top of these issues.As the world’s leading engineering and consulting company, NNE Pharmaplan is dedicated to enabling the pharmaceutical and biotechnological industries to fully utilise the opportunities of the future.Our focus on the pharmaceutical and biotech industries has enabled us to develop, innovate and refine engineering and consulting services that are specifically targeted at our customers’ needs and requirements. We have the industry’s leading expertise to help our customers translate change into competitive advantages.We work in interdisciplinary and cross-national teams, encourage innovative thinking for new technology solutions and provide training programmes for development of know-how and skills.Furthermore, we play a major role and are very active in professional societies such as ISPE (International Society for Pharmaceutical Engineering), FDA, ECA (European Compliance Academy) and others.Abbreviations in black box:PDA: Parental Drug AssociationsISO: International Organization for StandardizationFDA: US Food and Drug AdministrationSFDA: State Food and Drug Administration (in China)EMA: European Medicines Agency (formerly EMEA)WHO: World Health Organisation
  • Executing large projects is not our only focus. Many engineering firms are primarily organised for that purpose but our operation is a little different. We utilise our many years of experience and our production mindset to offer additional services that our customers need. We have seen a trend in the industry trend that the requests for services have been changing from mainly large projects to also include smaller projects. The business is becoming more complex and there is an excess of production capacity in some of our segments (e.g. biopharmaceuticals). The result has been growth in consulting and retrofit projects, which is reflected in our current work split:- 40% greenfield projects- 30% services (consulting)- 30% retrofit projectsAccordingly, the shift has significantly affected our business in terms of number of orders:- 2007 = 1268 orders- 2008 = 1571 orders- 2009 = 2121 orders- 2010 = 2667 orders
  • The pharmaceutical industry’s ability to advance in global competition has become increasingly dependent on Automation & IT. In order to stay ahead in the market, all elements in the value chain - from research, development and production to sales and distribution - must be supported by efficient and stable Automation & IT solutions. The ability to incorporate Automation & IT in the product itself is also of crucial importance in many areas.Ultimately, incorporating Automation and IT into your value chain can give you:- Increased capacity via automation- Performance optimisation via advanced control- Lean operation by removal of paper work- Higher quality level by in-process control- Compliance with relevant current regulations- Good overview by performance monitoring (OEE)- Employee satisfaction by removal of trivial operations- Risk minimisation by proven methods and technologies- Fast provision of new drugs to marketNNE Pharmaplan’s offerings:- Automation and Manufacturing IT strategies- Governance strategies- Conceptual design- Workflow and SOP planning- Life cycle planning- Migration strategies- System and vendor selection processes- S88 and S95 seminars- EMI strategies CASESNovo Nordisk: During a three-week shutdown period, NNE Pharmaplan implemented automation solutions that made it possible to transform a one-product production line into a multipurpose line.PronovaBioPharma: In 2009, our DeltaV application for the Kalomega project won the “PlantWeb Excellence” awardRead the full case story on http://www.nnepharmaplan.com/What-we-do/Case-stories/From-dietary-supplement-to-prescription-medicine/
  • Revamp is a fast and efficient way to increase capacity and flexibility in a ongoing production, compared to greenfield investments. Revamp includes all activities from analysis to running production, which ensures an exceptionally short production shutdown period followed by fast production ramp-up into guaranteed capacity. In short – revamp is an opportunity to postpone large investments and at the same time safely increase production capacity. At NNE Pharmaplan, we have developed an efficient and structured approach to revamping projects, which is used consistently across our organisation.We have completed hundreds of multi-product revamps and time critical upgrades using this approach, resulting in several record breaking projects in terms of installations modified in a shutdown.NNE Pharmaplan offers services on all aspects of revamping projects from front-end engineering and gap analysis through training to qualification services and handover of the revamped facility.CASESFresenius Hemocare CZ needed to revamp its existing production facility for blood bags. To be able to assemble, fill, sterilise and pack blood bags complying with ISO and cGMP requirements. NNE Pharmaplan completed the conceptual design and process engineering for the facility and delivered a turnkey solution for the HVAC and cleanroom systems.Read the full case story here: http://www.nnepharmaplan.com/What-we-do/Case-stories/Juggling-an-international-team-to-revamp-production-facility/In another project, we transformed one of two production lines in a facility from a one-product line into a two-product line, and we optimised the manufacturing capacity of both lines.And, when one of our customers needed to rapidly transform one of its cell culture facilities from a single-product facility to a multi-product production facility, we completed a major overhaul comprising the site infrastructure, facility expansion and upstream and downstream processes – and involving a team of nearly 100 engineers.
  • The ASTM E2500 standard presents an alternative to conventional commissioning and qualification practices, which - applied effectively - can save money and time while improving quality and increasing focus on patient safety.NNE Pharmaplan can help you in all aspects of transforming your current commissioning and qualification (C&Q) methods to an approach based on ASTM E2500 verification.The ASTM E2500 specialists of NNE Pharmaplan have worked – and are currently working – with several customers to change from the current C&Q approach to the ASTM E2500 verification approach. Typically, the primary project focus is not just the implementation of new standards or tweaking of the current C&Q approach but a re-evaluation of the C&Q process to achieve a significant improvement in cost and schedule efficiency.CASESPfizer Global Engineering wanted to change their traditional approach to validation. We assisted them in developing a new set of verification procedures, templates and guidelines based on ASTM E2500.Read the full case story on http://www.nnepharmaplan.com/What-we-do/Case-stories/NNE-Pharmaplan-assisted-Pfizer-in-setting-up-the-validation-of-the-future/We have also worked with another customer to design, build and validate facility fit for 21st century manufacturing – superior production efficiencies relying on value based investment:- To ensure new product hit the market at the right time whilst minimising risk- To ensure that current production does not suffer during rebuild
  • Recently, the pharma and biotech industries have seen a strong focus on ”personalised drugs”, which can be adapted to the specific needs of the individual patient. This will present completely new challenges and demands for flexibility and adaptability of the production facilities, which now need to be able to produce in much smaller batches.NNE Pharmaplan has experience from hundreds of cleanroom projects with many different applications in the pharma and biotech industries, and we have specialised experience within design and establishment of advanced therapy facilities and hospitals.We can help in all phases related to establishment of personalised drugs manufacturing – from front-end planning to gowning procedures and validation.CASESWe have helped the Norwegian Rikshospitalet University Hospital with services from design requirements, concept paper, detailed design to supervision of construction and delivery.In another project, NNE Pharmaplan delivered a turnkey cleanroom solution to Swedish-based SentoClone, a scientific research company originating from the Karolinska Institute, which is one of the world’s leading medical universities. The customer needed a cleanroom for research and development in cell therapy and personalised drugs for cancer treatment.See http://www.nnepharmaplan.com/What-we-do/Case-stories/State-of-the-art-turnkey-cleanroom-for-Swedish-company/We delivered the conceptual design for Bioheart’s biotech facility in South Korea. The facility produces patient-specific cell therapeutics for heart attack patients under GMP conditions.Read the full case story on http://www.nnepharmaplan.com/What-we-do/Case-stories/Conceptual-design-for-new-Korean-biotech-facility/
  • When planning a facility, it is important to find a partner who can hand over a facility that meets your goals in terms of time, cost and quality. NNE Pharmaplan’s experience ensures that your expectations are met. We offer the complete package for a pharmaceutical or biotechnological production facility, including the feasibility study, engineering, construction, production start-up and staff training. In most cases, our support begins with the selection of process technologies and continues after project handover.NNE Pharmaplan has built more than 150 turnkey production facilities all over the world. We have delivered a multitude of IV solution, API, biotech and medical device facilities. Some of the facilities were delivered completely modularised and pre- tested. And we have worked with several of our customers for more than 30 years – a testament of our customers’ confidence and satisfaction.CASESFor our Swedish customer, Orexo, we designed and constructed their cleanrooms as a turnkey solution – from basic design to construction and commissioning and qualification.Read the full case story on http://www.nnepharmaplan.com/what-we-do/case-stories/a-turnkey-cleanroom-project-for-the-pioneering-company-orexo/Beijing Fresenius Pharmaceutical needed a new validated production facility with European equipment. We delivered a turnkey facility, providing support throughout the project from validation master plan (VMP) up to the start of commercial production.The full project description is available on http://www.nnepharmaplan.com/what-we-do/case-stories/dedicated-team-delivers-validated-facility/Widatra Bhakti in Indonesia ran into capacity problems at their IV plant and asked us to provide a turnkey solution for the design and delivery of the main process equipment.You’ll find the full case story on http://www.nnepharmaplan.com/what-we-do/case-stories/long-term-relationship-supports-an-infusion-solution-facility/
  • Today, many pharmaceutical companies are facing patent expiry of significant products and generic competition is becoming stronger and stronger. The situation is further aggravated by cutting of health care costs in most countries around the world. The pressure for cost-effective production goes hand in hand with a continued or even increased focus on product quality. The pharmaceutical industry is forced to reinvent itself – through new quality paradigms, more efficient production and more cost-effective supply chains.As a global company, we follow the trends and opportunities of regulations, best practice industry standards and technology through our global network.And more importantly, we offer services locally through our many offices, adapted to your local needs as well as your global challenges.CASESRecently, one of our customers needed to optimise production time to increase their annual production capacity at a large pilot plant. NNE Pharmaplan’s solution included an upgrade of the CIP sequence to be fully automated. We also challenged the customer on their overall cleaning method and proposed a new and more cost-effective one.In 2006, Danish Novozymes inaugurated their high-quality, cost-efficient GMP facility in Hongda, China. Investment cost was a significant factor and most equipment came from local suppliers. Executed by NNE Pharmaplan’s Chinese organisation, the project is a perfect example of using local resources to have a global impact.Read the full case story on: http://www.nnepharmaplan.com/what-we-do/case-stories/local-knowledge-yields-strategic-cost-effective-chinese-enzyme-facility/

Transcript

  • 1. Engineering for a healthier world
  • 2. USA. A blood transfusion is vital at some point in the treatment of 5 million patients each year. CZECH REPUBLIC. Fresenius Hemocare has just revamped their facility, which manufactures blood bags. Our company film2
  • 3. Where we come from 1930s – Danish Novo and Nordisk Gentofte (later Novo Nordisk) employed the first engineers. With 80 years of 1974 - Pharmaplan was founded as part of the medical care group experience we are by Fresenius, Germany. passionate about our 1991 - After functioning as in- services to the pharma house consultants at Novo Nordisk and biotech industries. for years, NNE (Novo Nordisk Engineering A/S) demerged as an independent company. 2007 - Acquisition of Pharmaplan, a company similar to NNE in DNA. NNE Pharmaplan was founded. Recent awards 2004 IChemE: “Haden Freeman Award for Engineering Excellence” 2005 ISPE Facility of the Year Award winner – Novo Nordisk‟s NovoSeven (FVII) facility 2008 ISPE Company of the Year winner 2009 ISPE Facility of the Year Award winner – Facility Integration – hameln pharmaceuticals, Germany 2009 ISPE Facility of the Year Award winner – Operational Excellence – R&D division of US biotech company, Switzerland 2009 Emerson: “PlantWeb Excellence” for DeltaV application for Pronova BioPharma project (KalOmega)4
  • 4. Who we are We are the leading consulting and engineering company in the complex field of pharma and biotech. We count close to 1,700 professionals with project experience and knowledge related to pharma and biotech. More than 200 have hands-on development or production experience. We executed 2,667 projects Our project execution and our staff in 2010. embody 10,000 years of experience within pharma and biotech5
  • 5. Our future outlook We want to be the leading international supplier of projects, engineering and consulting services to the pharma and biotech industries. We advise organisations such as ISPE, PDA, ISO, FDA, SFDA, EMA and WHO6
  • 6. Our work split We have a 91% customer satisfaction The main part of our employees have a background rate. We are very in pharmaceutical production companies. proud of this fact.7
  • 7. Closer to our customers 97% of our revenues We employ close to 1,700 people at more than come from the pharma and biotech 25 locations in 11 countries around the world. industries8
  • 8. Global reach – local knowledge Certifications: ISO 9001 Worldwide ISO 14001 OHSAS 180019
  • 9. Optimal production processes DEVELOP ESTABLISH IMPROVEProcess & Product Project Investment project Optimisation, training, revamps, development development CD / BD / DD / CON / C&Q GAP analysis, operational support Company revenue 2010 USD 279M EUR 197M 10
  • 10. Our services11
  • 11. Single use With single-use technology you get maximum flexibility, fast change-over, no cross-contamination between products and a lower investment cost.12
  • 12. Risk-based approach and Quality by Design The answer to how you can avoid low-yield production or losing a batch.13
  • 13. Fast-track In traffic, fast is not a virtue. In pharmaceutical engineering we believe it is. And we have pushed the limits many times.14
  • 14. Automation and IT Automation & IT are key to obtaining competitive advantages by achieving faster, more efficient delivery at lower costs without compromising flexibility and quality.15
  • 15. Multiproduct revamps Revamping your production allows you to safely increase production capacity while postponing large investments.16
  • 16. ASTM E2500 verification ASTM E2500 is referred to as the validation of the future. How much money can it save you?17
  • 17. Personalised drugs and treatment The general trend moves away from „blockbuster‟ drugs to more personalised drugs, presenting completely new challenges to pharma companies.18
  • 18. Turnkey facilities A turnkey solution will save you the trouble of dealing with multiple suppliers – you get everything from a single source.19
  • 19. Cost-effective operation and facilities Cost-effective production is a must to survive in the highly competitive pharma market. Evolution calls for operational excellence, and we can help you get to the next level.20