Situated near Coimbra (Portugal) is Bluepharma, Indústria Farmacêutica SA, a state-of-the-art pharmaceutical manufacturing facility with an interesting history and an exciting prospect for the future.
Bluepharma’s management team attended Bio/PharMOS 2002, the event for contract manufacturing in Monte Carlo where the company exhibited its range of contract services and presented its research programme. As Bluepharma moves forward, Advances in Life Science discusses recent developments and future research with (pictured from right to left) Paulo Barradas Rebelo (CEO), Isolina Mesquita (Director of Operations) and Professor Sérgio Simões (Director of Research and Development).
Advances in Life Science: "How do you envisage the transformation of Bluepharma from its solid platform in contract manufacturing to emerge as a biopharmaceutical player?
Isolina Mesquita: "Just over two years ago, while I was plant manager for Bayer’s Coimbra site in Portugal, our parent company, made a business decision to consolidate production at its headquarters in Germany. Bayer announced plans to sell the Coimbra manufacturing site by advertising in an International magazine.
"Paulo read about the planned sale. His background is in management and logistics. Paulo contacted Sérgio, who worked in research locally as a professor at the Coimbra University. Paulo and Sérgio and I decided we would set up a new company, Bluepharma, with the aim of acquiring the Bayer plant and developing it as an integrated contract manufacturing business.
"It was important for Bayer, being a multinational company, that whoever acquired the plant would understand the manufacturing business, maintain employment within the company and also develop the business. It was essential for the acquirer to have a credible business plan as well as a sound financial position. Bayer wanted a number of interested companies from which to make a choice.
"It was a fair competition. Prospective buyers had to present a business plan for Bayer and discuss their strategy to develop the business. As a Bayer employee I had to take any interested party on a tour of the facilities. I wanted to be sure that whoever Bayer sold the plant to in the end the new owner would feel comfortable with our knowledge and experience and we in turn would feel comfortable working with them. As it turned out, the most credible business plan came from Bluepharma, because our team understood and knew how to set about growing the business.
Advances in Life Science: "What skills and experience have you brought into the business?
Paulo Barradas Rebelo: "I gained management, business skills and experience in logistics from a background as CEO of a major wholesaler and distribution company to about 500 pharmacy units within a co-operative. This accounted for 20% of all pharmacies in Portugal or 5% of the market. This experience made me realise that Bluepharma would be competent to go into the manufacturing business and to acquire the site as well as develop the business. We raised some capital ourselves to acquire the business. We believe in the business and are committed to making it successful.
Sérgio Simões: "I had been looking to acquire or set up a biopharmaceutical facility for research and development and providing pharmaceutical development services to capitalise on the strong knowledge and research environment that exists in the health scene in Portugal. We have several hospitals in Portugal one of which is a University Teaching Hospital. There are several research institutes, some of with an International recognition.
"An International consulting organisation conducted a study comparing biopharma research in Coimbra with that in Montpellier and Cambridge. They found the environment was very favourable for developing biotech projects in Coimbra. We were able to pre-empt this positive and favourable environment for developing projects including production in this field before the national government decided in 2001 to declare its intention to focus on biologics and pharmaceuticals business in healthcare as a priority.
"Coimbra is considered as Portugal’s ’Capital of Health’ because of the scientific community, the many centres focused on Life Sciences and the historical importance of the University. Several research studies initiated by the Government identified this area as a vector for economic growth in the region. Bluepharma may be considered an innovator within this new framework in the relationship between the University and the business sector.
Advances in Life Science: "Who else is involved in management of the business?
Sérgio Simões: "There are three others. Each owned a pharmacy business so they have experience and knowledge of the market. Our skills are complementary. When I had a permanent post at the University, I used to take students to visit production sites in Portugal.
"This site is one of the best that we have in Portugal, not only in terms of equipment and the design of the facilities but also the high standards of quality and the calibre of the people who work here. Most have degrees and some have post-graduate degrees (MSc and PhDs) as well. We see our team as Bluepharma’s most valuable asset. It’s a close, robust and strongly motivated group, with a high technical and scientific capacity
Advances in Life Science: "Please describe Bluepharma’s production capabilities.
Isolina Mesquita: "At this site we produce tablets, coated or uncoated, capsules, ointments, creams, granulates, powders, suppositories and liquid formultions. Last year, we produced about 200 million tablets (10 million packages) and 50 tonnes of ointment using one working shift per. We could double the quantities quite easily by carrying out another shift without any additional machinery or expansion of facilities. We have up-to-date equipment and automated packing lines for solids with strict in-process controls. We also carry out many different types of packing to the highest quality standards.
"Our Quality Control facility consists of three laboratories - two for physico-chemical analysis and one for microbiological analysis of raw materials, packaging materials, semi-finished and finished products in order to comply with GLP and GMP. The microbiological laboratory also monitors the environment of demineralised and potable water, air, equipment surfaces, overcoats and gloves of operators who are in contact with the products.
Advances in Life Science: "How do costs compare with other manufacturers?
Isolina Mesquita: "In the case of active pharmaceutical ingredients (APIs), depending on what the potential client wants, he may ask for a quotation and specify his request for suppliers according to his Company’s registration dossier. It may only include the APIs, which enables us to use our own suppliers.
"Portugal isn’t a major producer of APIs unlike some countries in the AsiaPacific region. Therefore we source our raw materials not only in Portugal but anywhere in Europe, as long as they are certified suppliers with good quality production. Thus, we may compete with other European contractors, which use the same suppliers. In the case of raw materials for packaging, which among the more expensive manufacturing costs, we use Portuguese suppliers. We find them very cost competitive in comparison to other European suppliers.
"Labour rates are competitive as the cost of living is lower in Portugal than most countries in Europe even though standards of living are similar. In Coimbra, operators are prepared to work at a reasonable and competitive wage. We are near the Universities for recruiting qualified staff. Coimbra is a beautiful place. We are fortunate to be located in a residential area, which is well developed and not an industrial estate as with many manufacturing sites elsewhere in Europe.
Advances in Life Science: "What about the impact of your location on distribution logistics?
Isolina Mesquita: "We have no difficulty distributing our clients’ products anywhere in the world. As plant manager for Bayer for 18 years, I made sure our products were produced and delivered in time.
"Coimbra enjoys a privileged location - two hours from Lisbon airport and one hour from Oporto airport by car. It is a 20 minutes drive from the harbour at Figueira da Foz. We have excellent roads, which are not congested with traffic, and trains, which usually travel on time.
"Our warehouse complies with all the requirements of Good Distribution Practice, with controlled temperature and humidity and a cold chamber. We have capacity to store and deliver large volumes of pharmaceutical products including pre-wholesaler distribution. Last year we distributed seven million packages to other countries.
"We invest in the facilities to ensure the quality of the products we manufacture and distribute and to safeguard the working conditions of our employees through implementation of a Quality, Environment, Hygiene and Safety system. This is in accordance with ISO 9000, IISO 14001 and OHSAS 18001, GMP and other relevant legislation. We have a surgery for a doctor to visit weekly to check the health of any employees needing treatment or medical advice. We invest in training our employees.
Advances in Life Science: "Do you plan to expand?
Paulo Barradas Rebelo: "Our buildings occupy about 12,000 sq m at several levels on land of 18,700 sq m. The buildings have had several improvements, the most significant being in 1989 and 1998. We have land to expand. We plan to build a laboratory between our two main buildings to do more research and development work.
Advances in Life Science: "What is planned for research and development?
Sérgio Simões: "Pharmaceutical development services offered by contractors are becoming very important as more and more companies outsource their development work after they have discovered a new molecule. Small biotech start-ups are also developing new entities and require clinical trial samples or even just to formulate compounds.
"We will collaborate with research centres and the University where I still lecture. Hence we are expanding our pharmaceutical development facilities. We have the expertise to work on formulation development, pilot scale and scale-up, controlled release forms, drug delivery forms and biotech materials. I worked on this research at the University in collaboration with the manufacturing plant at Coimbra until our Bluepharma venture took over the site.
"Our site is built in a green area of natural gardens and woods, creating a harmonious environment perfectly integrated with its surroundings. We are concerned about the environment so our handling of solid and liquid industrial residues is subject to the strictest controls.
"Industrial effluents are treated in a modern, waste-water treatment system in compliance with applicable legislation and with recommendations of NP EN ISO 14001. We received an award for "Good Practice in Workplace - Healthy Employees in Healthy Organisations" by Workplace Health Promotion in Europe.
Advances in Life Science: "What is your vision for Bluepharma?
Paulo Barradas Rebelo: "Our mission is to market the highest quality products at competitive prices. It fits the Government’s objective of rationalising expenses in the health sector while simultaneously improving the quality of life. To achieve this, our vision is to be the leading contracting manufacturing organisation in Portugal.
Click for further information about Bluepharma
Related article - EC award for biotech innovation
Contact: imesquita@bluepharma.pt
Keywords : Contract pharmaceutical manufacturing Portugal Bayer Management Buy-out (MBO)
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