Case stories

Case stories from our customers.

• A turnkey cleanroom project for the pioneering company Orexo

  Orexo is a specialty pharmaceutical company, focusing on development of new, patented drugs by combining well-documented substances with innovative technologies, and the development of the new treatments for respiratory and inflammatory diseases.

• Auto-disabled syringes save lives in developing countries

  The World Health Organization (WHO) knew that auto-disabled syringes would slow the spread of deadly diseases in developing countries. But to put the plan into action, WHO needed expert design and production support. It turned to NNE Pharmaplan – whose innovative syringe design is now used by UNICEF.

• Award-winning biotech facility

  This ambitious Novo Nordisk project resulted in one of the largest biotech facilities and most advanced part 11-compliant automation systems in the world.

• Building Malaysia’s first GMP-compliant biotech production facility

  In 2005, Inno Biologics set out to build Malaysia’s first GMP-compliant biotech facility. Now completed, the facility has taken Inno Biologics to the forefront of the country’s biotech sector.

• Building R&D facilities that are something special

  Developments in the field of drugs, vaccines and diagnostics have resulted in significant advances in the prevention, diagnosis and treatment of diseases. These advances are the result of continuous research, which is fundamental for improving public health all over the world. Research institutions rely on competent people to provide high-level research output and quality.

• Building the world’s most cost-efficient, advanced biofuel demonstration plant

  In today’s global arena, where global warming and environmental concerns are on top of the agenda, industrial biotech companies play a significant role. The innovative products and technologies that come out of the industrial biotech segment contribute significantly and positively to global change and to the lives of all of us.

• Building to boost healthcare in Russia

  Russia’s booming pharmaceutical industry is attracting major investments. In 2010, the Russian pharmaceutical distribution company R-Pharm started construction of a new drug production facility for the treatment of socially significant diseases.

• Building to help changing diabetes in China

  The pharmaceutical industry is booming in China, and significant investments are made. Novo Nordisk is also part of the boom with a new plant in Tianjin, which will become the world’s most modern insulin formulation and filling plant. And at DKK 2.1 billion, it is Novo Nordisk’s biggest investment outside Denmark. NNE Pharmaplan is strongly involved in establishing the plant and involved in all engineering disciplines.

• Conceptual design for new Korean biotech facility

  NNE Pharmaplan’s expertise in process technology for patient-specific cell-therapeutics and GMP compliance was needed when a customer had to set up a new production facility in South Korea.

• Coordination of qualification and validation support for a new vaccine facility

  When GlaxoSmithKline Biologicals needed to build a new production facility, it turned to NNE Pharmaplan for qualification and validation support. The facility was finished on schedule and in time to meet seasonal production demands.

• Cross-national project team delivers high-potent API production facility

  Pharmaceutical company Synthon needed a new facility for the production of high-potent active pharmaceutical ingredients (APIs) by chemical synthesis. The company chose NNE Pharmaplan to design and construct this facility.

• Customised single-use solution for production of gene-based products

  Ark Therapeutics Oy needed a BSL2 cell-culture manufacturing plant based on single-use process technology and they had a short timeline to realise it, so they turned to NNE Pharmaplan for the solution.

• Dedicated team delivers validated facility

  Beijing Fresenius Pharmaceutical needed an experienced partner to establish a new validated production facility with European equipment. NNE Pharmaplan did exactly that – and also stayed on site until production was running with full GMP compliance.

• Designing a hospital cleanroom for 24/7 operation

  Providing treatment and medical products to patients at the right time and with the proper quality is crucial for ensuring patient safety, and thus something which all organisations that operate within the health care and life sciences industries aim for. Accordingly, organisations strive to preferably avoid or at least minimise operation shutdowns – not least in the context of hospital cleanrooms, where it can make a difference of life and death.

• Fast-track facility project for getting infusion solutions fast to market

  Widatra Bhakti, Indonesia’s leading infusion solution manufacturer, is building a new large volume parenterals facility based on NNE Pharmaplan’s design. The project is expected to become yet another success story in the two companies’ long partnership history.

• From dietary supplement to prescription medicine

  Cardiovascular diseases claim 17.1 million lives a year worldwide – more than any other disease. Many of these lives could be saved with a healthier diet, in addition to life-saving therapies such as prescription omega-3 fatty acids. NNE Pharmaplan helped Pronova BioPharma double its production in a successful grand finale to the era of mega projects.

• GMP upgrade while maintaining full-scale production

  How can you ensure production remains smooth while revamping and upgrading a production facility? This is the challenge facing Merz Group Services in Germany – and NNE Pharmaplan’s engineering and construction management expertise is meeting the challenges.

• Groundbreaking plant received the Facility of the Year Award 2005

  Novo Nordisk A/S developed a drug for the treatment of spontaneous and surgical bleedings in haemophilia A and B patients with inhibitors against other replacement coagulation factors. These patients suffer from severe bleeding that is uncontrollable and life-threatening. Using this drug not only improves their daily lives, but it also allows them to undergo major surgery with a greatly reduced risk of haemorrhaging and complications, which is very common for haemophiliacs.

• High-containment facility in China with numerous production possibilities

  In 2005, Chinese company Hisun decided to build a new production facility for sterile and non-sterile dosage forms under high-containment conditions. The facility had to be fully cGMP- compliant and be able to produce a range of products.

• Holistic approach to process analysis boosts productivity of sterile production line

  When Fresenius Kabi Austria needed to increase the productivity and output of an existing production line, it looked for a technical consultant that shared its comprehensive take on problem solving.

• HSE management in action

  Our customers in the pharmaceutical and biotech industries often have ambitious HSE requirements. Through the application of OHSAS 18001 and ISO 14001 standards, we have developed an HSE management concept that can help you meet your HSE goals with cost-effective and efficient systems.

• Juggling an international team to revamp production facility

  Fresenius Hemocare CZ needed to revamp its existing production facility for blood bags. The company chose NNE Pharmaplan for compliance expertise, and received an added bonus of outstanding team management.

• Korean pharmaceutical company gains skills to execute own facility qualification

  Companies often want to carry out tasks using their own staff – but need the right support to make sure things are done correctly. That was the situation facing pharmaceutical company Kyung Dong when it decided to do its own qualification of a new facility.

• Local knowledge yields strategic, cost-effective Chinese enzyme facility

  On a competitive environment, enzyme production must be as cost efficient as possible. Thanks to its longstanding presence in China, NNE Pharmaplan was able to build a production facility within local cost constraints to supply enzymes to support the growing market.

• Long-term relationship supports an infusion solution facility

  Widatra Bhakti was running into capacity problems at its infusion solution facility. Based on its long-term relationship with NNE Pharmaplan, the company got the facility extension it needed while meeting the demands of new authority requirement.

• Meeting the need for vaccines in record time

  Although the infectious disease smallpox has been eradicated, governments are showing renewed interest in developing and stockpiling smallpox vaccines as a precaution against bioterrorism – in the US, this is being driven by its BioShield initiative. One of the world’s safest, multivalent vaccine vectors for the development of vaccines against smallpox is MVA-BN®, based on Bavarian Nordic’s patented technology.

• Meeting tight shutdown deadlines for qualification

  Every year, CSL Behring races against a tight schedule to complete qualification activities during the summer shutdown. Assisting with the qualification work, NNE Pharmaplan helps to make sure that production restarts right on time, every time.

• New pilot plant for SVPs within limited space

  The R&D division of the largest US based healthcare company located in the northern part of Switzerland needed a new facility for SVPs built onto its existing site. NNE Pharmaplan’s innovative and creative approach led to the successful development of an optimal new facility.

• New production facility for biomaterials under GMP conditions

  In 2004, the renowned company Geistlich Pharma in Wolhusen, Switzerland was faced with a substantial surge in demand for their biomaterials (“Bio-Oss”) used as bone implant in surgical operations.

• NNE Pharmaplan assisted Pfizer in setting up the ’Validation of the Future’

  When Pfizer wanted to change their traditional approach to validation, NNE Pharmaplan’s in-depth knowledge of the new ASTM E2500 ‘Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment’ made us the obvious choice to help out.

• NNE Pharmaplan constructs large plant for AstraZeneca in Wuxi, China

  On 27 April 2011, the ground-breaking ceremony for AstraZeneca’s New Injection Solution Plant (NISP) was celebrated at the company’s Wuxi site. This is an important milestone for both AstraZeneca and NNE Pharmaplan.

• NNE Pharmaplan contributed to operational excellence

  In 2009, hameln pharma’s sterile production plant designed by NNE Pharmaplan was awarded the prestigious international ISPE Facility of the Year Award in the operational excellence category.

• NNE Pharmaplan supports UCB Pharma in fighting severe diseases

  The global biopharma company UCB Pharma has decided to build a cGMP biotechnological pilot plant including development laboratories on its site in Braine-l’Alleud in Belgium. The aim is to speed up availability of biotechnological drugs for serious illnesses in the central nervous system and immunological problems, concentrating on pilot projects and delivering products for clinical trial activities.

• Novo Nordisk puts PAT in place, from strategic planning to implementation

  Novo Nordisk Diabetes Finished Products needed a strategy for Process Analytical Technology (PAT), but had no formal PAT organisation in place or implementation plan for this part of the Novo Nordisk organisation. So the company turned to NNE Pharmaplan to ensure PAT was implemented successfully, quickly and economically.

• Outstanding team effort creates fast-track and future proof results

  LEO Pharma is an independent, research-based pharmaceutical company and one of the world’s leading companies within the treatment of dermatological diseases. In a joint effort with NNE Pharmaplan, the company recently modernised and optimised their API pr

• Pharmaceutical plant built in new record time

  Novo Nordisk is a healthcare company known for quality and innovation. So when the company had to expand its production capacity for a new insulin analogue, new suggestions were welcome – as long as the end result met its high expectations.

• Pioneering facility for safe production of sterile active pharmaceutical ingredients

  To meet new authority requirements, Baxter Oncology GmbH needed to provide safer operating conditions for its high-potent active pharmaceutical ingredients (APIs) production facility. NNE Pharmaplan was commissioned to design and implement a new facility that would be one of the pioneer projects within the high containment sector.

• Process simulation provides clear vision of future productivity

  Imagine being able to see into the future. Thanks to sophisticated process simulation tools, that’s exactly what Fresenius Kabi Brazil Ltda was able to do when it planned to expand and modernise an existing facility for the production of infusion solutions.

• State-of-the-art drug delivery device production in China

  A competitive cost level and the company’s overall internationalisation strategy of increasing presence in China were the motivational factors for Novo Nordisk’s decision to transfer the assembly and packaging of its NovoPen®4 from Denmark to China.

• State-of-the-art turnkey cleanroom for Swedish company

  SentoClone, a Swedish life science research company that develops and markets a cancer treatment method, needed a cleanroom and process unit to be constructed in a historically protected building in Stockholm. To deal with the challenges involved in the job, SentoClone turned to NNE Pharmaplan.

• Successful qualification through early planning

  Rentschler Biotechnologie needed to expand its existing manufacturing capacity with several production lines for biotechnological products. And it had to have consistent qualification documents in all areas to ensure the facility passed inspection. NNE Pharmaplan took over all qualification coordination to help ensure success.

• Turning yesterday’s traditional wisdom into tomorrow’s innovative health solutions

  Biotropics Malaysia Berhad merges top-class R&D with ancient knowledge of herbal medicine in facilities that comply with international ISO 17025 and Good Laboratory Practices (GLP) standards.

• Two-stage flow system improves quality control

  Novo Nordisk wanted to reduce transition time for the release of packing material by implementing a flow system. With a two-stage solution, the company has cut transition time from up to eight days to just one day.