Polpharma Biologics is a division of Polpharma, an FDA-approved manufacturer of pharmaceuticals and a leader in the Polish pharmaceutical market. Polpharma Biologics opened full-scale operations in the new Science and Technology Park in Gdansk, Poland.

We are engaged in the development and manufacturing of biosimilars for global markets and have built an integrated organization with a leadership team with a proven track record of global biologics development, production, registration and commercialization including in the EU, US and Japan.

Based on our development and production experience we offer process and analytical development as well as GMP manufacturing services for mammalian products (biosimilars as well as originator molecules, especially monoclonal antibodies) to customers worldwide. We aim to provide fast and flexible development and manufacturing services with global quality standards, meeting FDA, European and Japanese requirements, accompanied by full regulatory support.

Our mission is to provide our customers with world class development capabilities and a capacity for industrial-scale supply, enabling them to advance their medicinal product and help patients in need.

We aim to provide:

  • A fast, flexible and responsive service to customers,
  • Focused expertise on mammalian cell based products and
  • Capabilities spanningthe the full range of process and analytical development to GMP manufacture of drug substance meeting international quality standards.

Polpharma Biologics is a division of an established pharmaceutical company licensed by the FDA to manufacture drugs for therapeutic use in humans. Polpharma Biologics’ core business focus of producing and selling Biosimilar drugs is now expanded by offering world class contract R&D services and cGMP production capability to external customers.

Hannes Teissl, Management Board Member

Gx & biosimilars executive with track record in financial, M&A, commercial and GM positions.

22 years at Sandoz, with top executive positions

  • Global Commercial Head for $1bn Anti-Infectives Franchise (API and outlicensing)
  • Head Business Unit Biopharmaceuticals, Member of Sandoz Executive Committee
  • CEO Sandoz Germany managing biosimilar hGH and Epo launch plus other branded Gx
  • Head Integration Office for global integration of Hexal, Eon Labs into Novartis
  • Global Head M&A, managed USD 8 bn Hexal acquisition plus 15 other transactions
  • Region Head for Asia Pacific
  • Region Head for Latin America and CEE

Master of Business Administration from University of Innsbruck

Klaus Martin, BD & Development Director

Broad biosimilars development and BD experience for highly regulated global markets

8 years at Sandoz Biopharmaceuticals,

  • Project Leader Filgrastim and Rituximab
  • Head of Global Pre-/Clinical Development
  • Head of BD&L and Portfolio Management

1999-2002: strategy consultant with OC&C

MSc in biochemistry from FU Berlin and PhD in Pathology from the University of Cambridge

Tomasz Góralczyk, Director Business Development and Alliances

Director Business Development and Alliances

15 years’ experience in Business Development, both in- and out-licensing

2000 – 2004: Head of Foreign Projects Department at Adamed
2004 – 2006: New Product Acquisition Manager at Polpharma
2006 – 2011: Head of Licensing-out Polpharma Group
2011 – 2013: Licensing-out Director Polpharma Group

MSc in Molecular Biology from Jagiellonian University in Cracow.

Piotr Zień, Technical Development Director

Polpharma Biologics‘ Technical Development Director

2006-2010: Project Manager for Adamed
2007: Project Management Associate Washington

Post-Doctoral Fellowship in the Department of Biochemistry at the Univ. of Western Ontario

Member of Program Board in the leading Polish university in Krakow

Graduated from UMCS in Lublin

Justin Lynch, Head of QC and QA

Qualified Person and Pharmacist with wide ranging experience in Pharma. manufacturing and Clinical operations within Quality and Technical roles.

15 year’s experience throughout the lifecycle of medicines from development through to patient administration and monitoring.

7 Years as a Qualified Person in Ireland at Fannin Healthcare and Astellas Ireland.

      • QP release of Non-sterile and Aseptically Produced Finished Medicinal Products
      • Management of QA/QC teams
      • 3rd Party vendor Management
      • QMS system development
      • Recruitment Training and Development of Quality Teams

8 Years experience in the UK National Health Service within London Teaching Hospitals

      • Clinical and Technical experience in Non-sterile, Aseptic and Oncology medicines
      • Quality Assurance and Quality Control experience including regulatory audit preparation.
      • Clean room build, Qualification/Validation and Project Management experience.

Master of Pharmacy Robert Gordon University Aberdeen, Master of Science University of Leeds, Master of Business Administration from University College Dublin

Michael Trieb, Head of Regulatory Affairs

Regulatory expert with broad global (EU, US, JP) biosimilars and vaccines experience

2009-2014: Regulatory Compliance and Early Development positions in Novartis Vaccines
2004-2009: Head of Regulatory CMC at Sandoz

Building and leading different regulatory affairs teams in a global setting

PhD in natural sciences at Univ. of Innsbruck

Exec. MBA / Consortium of 6 EU Universities

Initiator of Innovation

May 2015

Polpharma was awarded in Newsweek’s Initiator of Innovation contest, whose aim is to promote innovativeness on the Polish market. The awards in the contest were given in four categories: Large Enterprises, Small & Medium-sized Enterprises, Start-ups and Innovative Project of the Year, i.e. a project implemented jointly by science and business. Polpharma won the award in the Large Enterprises category. The chapter of the contest recognized and awarded our activity contributing to the building of a culture of open innovation both inside and outside the organization. We owe our success to the extensive commitment to innovative social activities, to the building of collaboration with science & research, as well as to our organization’s continuous improvement. The award also represents an obligation and a challenge for us: as a role model for others, we need to keep up the hard work we have been doing so far.

Innovator for Polpharma Biologics

October 2014

Polpharma Biologics was awarded the 2014 Innovator by “Wprost” in the Science category. The second institution the receive this was the Medical University of Warsaw.

Our Company was awarded for creating a state of the art biotechnology center in Poland in the Gdańsk Science and Technology Center. It is the largest facility of its kind in Poland, and offers an opportunity to train and develop the brightest young scientists by working with experienced experts in the biotechnology industry. Conducting research on the production of biosimilars, Polpharma Biologics wants to offer patients cheaper alternatives to existing medicines and allow wider access to effective treatments. The company was represented by Piotr Zień, Polpharma Biologics Technical Development Director.

“Wprost” Innovators is an award given since 2011. This year, the basis for granting an award was the 2014 autonomous Innovation Research survey. Innovators Statues went to the best companies in the most dynamic sectors of the economy, among others, pharmacy, energy, industry, construction, telecommunications, finance and science.

Process Developement

A comprehensive development team, located in Gdansk, Poland, provides top class services in upstream and downstream process development. We develop and optimize processes or transfer existing ones according to regulatory and economic needs.

We offer:

Experienced R&D staff dedicated to develop:

  • Mammalian cell based processes at laboratory scale - using shake flasks, 15 ml microbioreactors up to a maximum scale of 10L
  • Antibody Purification Platform,
  • Design of Experiment (DoE) solutions to optimize both USP and DSP development,
  • Scale-up and transfer to large-scale production at 1000L,
  • Process characterization at laboratory scale.

Please contact us for full list of Process Development capabilities.

Analytical Development & Quality Control

With state of art analytical equipment and customer focused personnel we are ready to support comprehensive characterization of biomolecules both at physical-chemical and biological levels (cell based assays included). All methods will be developed and qualified by our Analytical Development group and then transferred to the Quality Control department for validation and GMP release testing.

We offer:

  • Analytical method development,
  • Qualification and Validation,
  • Stability testing,
  • Raw material, in-process and release testing.

Please contact us for full list of Analytical Development and Quality Control capabilities

Manufacturing

Polpharma Biologics has built a state of the art, multi-purpose GMP manufacturing facility in Gdansk, Poland.

This facility is designed to ICH standards and is dedicated to the manufacture of recombinant proteins, including biosimilars, based on mammalian cell culture technology using disposable technologies.

The GMP services offered can be customised to suit each client’s specific requirements and include:

  • Master and Working Cell Bank production, storage and characterisation,
  • Technology transfer and process scale-up in addition to
  • Producing GMP supplies up to 1000L.

We are able to supply GMP material for all phases of clinical studies as well as commercial use.

Our experienced, trained scientists follow the highest quality standards to generate bulk drug substance. Polpharma Biologics can also offer customised fill and finish services. Our GMP testing Laboratories support the testing of products at all stages of development and GMP manufacturing.

European approval of the biotech facilities is expected in early 2016. A second 1000 L fermenter will be installed in 2017 and further production expansion for 3 x 2000 L is in preparation and will be available in 2018.

High quality and innovative solutions tailored to the customers’ needs

We provide a comprehensive range of services tailored to each individual project, whether providing de novo process development, process optimization or transferring in your fully developed process.

We invite you to meet us and learn more about our new biologics division. We aim to provide fast and flexible development and manufacturing services with global quality standards, meeting FDA, European and Japanese requirements, accompanied by full regulatory support.

Quality is an integral part of our activities. Our staff are trained to ICH cGMP standards and our Quality Assurance group benefits from the long regulatory history at Polpharma and can offer product release services if required.

It’s good to work with us

Working at Polpharma Biologics offers a broad spectrum of opportunities for highly experienced professionals as well as young graduates who have just began their career.

What are the benefits of working at Polpharma Biologics?

Contributing to projects which will improve people's lives - through development of biotech medications our Company aims to improve patients' lives by giving them access to new therapies, and to innovative methods of treatment for life threatening diseases.

Contributing to the success of a modern Polish biotechnology company - using science to introduce innovative technologies will allow Poland to become not only a consumer but also a world class manufacturer of biological drugs.

Learning new technologies - the R&D center which is located in Gdansk Science and Technology Park, guarantees a unique atmosphere emphasizing self-improvement and provides it’s employees with unparalleled opportunities to learn modern biotechnology.

With the stability of 80 years of experience - Polpharma, a leader in the Polish generic drug market, has always aspired to achieve ambitious goals especially when developing it’s biotech capabilities.

Polpharma is always in search of excellence in delivering safe and effective medicines to meet patient's needs.

Hiring process

Polpharma Biologics is a dynamic environment very well suited for creative and flexible individuals with innovative thinking, who can rapidly start new research programs in biopharmaceuticals, and equally quickly bring them to successful conclusions. The unit employs experienced professionals as well as promising graduates in biotechnology, pharmacy, medicine and other related disciplines. Recruitment is ongoing internally at Polpharma and its affiliates, as well as externally.

Recruitment process involves:

Application analysis:

We will determine the level of match between the qualifications of a candidate, and the requirements for the position he/she applied for. All applications will be processed and selected candidates will be invited for an interview.

Interview:

During the interview process the applicant will meet with a senior member of the management team and a Human Resources representative. This will allow more precise assessment of each candidate’s key competences required for the position.

Questionnaire and/or knowledge assessment as well as practical skills test:

Candidates may be asked to take part in a laboratory practical test which will determine the ability of the applicant to solve typical experimental problems, at the difficulty levels commensurate with the position the candidate has applies for.

Successful applicants will receive job offers, while all other candidates who participated in the recruitment process will receive appropriate feedback.

Job offers

There is no vacant job position at the moment. Please check again later.

news

Polpharma Group enters into partnership with EPIRUS

16 July 2015

In July 2015, Polpharma Group and EPIRUS entered into a multi-product, multi-region, profit-sharing collaboration to advance select biosimilars, including BOW015, BOW050 and BOW070, in EU, Middle East, Turkey Russia and CIS territories.

In July 2015, Polpharma Group and EPIRUS entered into a multi-product, multi-region, profit-sharing collaboration to advance select biosimilars, including BOW015, BOW050 and BOW070, in EU, Middle East, Turkey Russia and CIS territories. Both parties will jointly fund clinical development and collaborate on regulatory filings in the specified territories. EPIRUS will also be responsible for process development, scale-up and manufacturing, with Polpharma Group overseeing commercialization across the territories. Clinical development costs and eventual operating profit will be split 51 percent Polpharma Group and 49 percent EPIRUS.

“Partnering with EPIRUS allows us to combine their technical expertise with our commercial strength” - said Jerzy Starak, Chairman of the Supervisory Board, Polpharma Group. “We are pleased to join the experience of both teams and the potential of these markets to provide patients with more affordable access to modern treatment.”

EPIRUS retains the commercial rights to Switzerland and Norway along with select EU countries including Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands and Sweden.

A joint management board will oversee the collaboration.

EPIRUS Biopharmaceuticals is a biopharmaceutical company focused on building a pure-play, sustainable, profitable biosimilar business. As such, EPIRUS will be able to improve patient access to important, cost-effective medicines worldwide. EPIRUS' current pipeline of biosimilar product candidates includes BOW015 (infliximab, reference biologic Remicade®), BOW050 (adalimumab, reference biologic Humira®) and BOW070 (tocilizumab, reference biologic Actemra®). The reference products for these candidates together generated $23 billion in global sales for 2014, according to EvaluatePharma®. EPIRUS has developed distinct strategies to penetrate the global market, leveraging partnerships to optimize value retention over the long-term. 

For more information visit EPIRUS' website at www.epirusbiopharma.com.


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EIB supports pharmaceutical research and development in Poland with EUR 45m loan to Polpharma

03 June 2015

The European Investment Bank (EIB) is lending EUR 45m (around PLN 185m) to Polpharma, for its research into and development of biosimilar drugs – more affordable alternatives to current treatments. This is the first EIB operation in Poland supported by the new generation of financial instruments for innovative and growth companies, “InnovFin – EU Finance for Innovators”, with the financial backing of the European Union under Horizon 2020.

The aim of the project of Polpharma is to provide patients with wider access to modern biological drugs and also to address unmet medical needs in the area of severe and life-threatening diseases such as cancer, Crohn’s disease, multiple sclerosis and rheumatoid arthritis.

Europe’s long-term lending institution is strongly committed to supporting fast growing, innovative and expanding Polish companies like Polpharma and encourages innovative research in the healthcare sector. Both development and manufacturing of biosimilar drugs requires strong research and development efforts, such as optimising production in a sensitive cell culture and extensive clinical trials proving therapeutic equivalence to the original biological drugs. For projects of this nature and risk profile, it is the diversification of funding sources, long maturities and favourable terms offered by the EIB that companies like Polpharma find attractive.

Pharmaceutical research into and the clinical development of new therapeutics are one of the most costly and risky areas of knowledge creation. The “InnovFin Large Project” facility is specifically dedicated to improving access to risk finance for research and innovation projects originating from larger firms in the European Union. Through its research, development and innovation activities, Polpharma will contribute to increasing patient access to essential drugs in Europe in areas that are crucial for the improvement of its citizens' health. The project will be implemented in the company’s facilities in Poland, safeguarding and creating employment opportunities for the skilled workforce in the country. Given Polpharma’s collaboration with universities, the knowledge acquired through the research activities will also be widely disseminated across Europe.

László Baranyay, EIB Vice-President responsible for lending in Poland, said, “We are pleased to be partnering with Polpharma in this breakthrough operation as it will enable the EIB, the bank of the European Union, to support innovative research and development of more affordable healthcare treatments in Poland. Polpharma is a role model for our support for fast growing, innovative and expanding companies in Poland. Projects such as this strengthen the competitiveness and boost the innovative capacity of European health-related industries and businesses.”

Jan Faryaszewski, Vice-President of Polpharma Pharmaceutical Works, added: “Development in biotechnology requires huge investment and the building of long-term partnerships. Polpharma's business goals are in line with the EIB’s strategy of supporting innovative projects over the long term. As a Polish innovation leader we are happy to collaborate with such an important and solid partner. We believe that our partnership will contribute to faster development of biological drugs that are important for patients.”


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Bioinnovation International Summit 2014

29 October 2014

On 20th and 21st October the Bioinnovation International Summit 2014 conference was held in Gdańsk Science and Technology Park.

Polpharma Biologics was the expert partner of this international event. During the conference experts in biotechnology, chemistry, pharmacy and medicine met with representatives of the business and with students. The program included lectures, inter alia, on: GMP, technology transfer, technical development of biosimilar medicines, clinical trials and projects funded with grants. During the conference the speakers from Polpharma were Dr. Monika Lamparska Przybysz, Dr. Tomasz Kosieradzki, Dr. Piotr Zień and Mrs. Emilia Łoś.

More information on Bioinnovation International Summit 2014 can be found at LINK


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Innovator for Polpharma Biologics

29 October 2014

Polpharma Biologics has been awarded the 2014 Innovator by “Wprost” in the Science category. The second awarded institution was the Medical University of Warsaw.

Our Company was awarded for creating a state of the art biotechnology center in Poland in Gdańsk Science and Technology Center. It is the largest facility of its kind in Poland, and offers a chance of development for the brightest young scientists who have the opportunity to work with experienced experts in the biotechnology industry. Conducting research on the production of biosimilars, Polpharma Biologics wants to offer patients cheaper alternative and allow wider access to effective treatment. The company was represented by Piotr Zień, Polpharma Biologics Technical Development Director.

“Wprost” Innovators is an award given since 2011. This year, the basis for granting an award was the 2014 autonomous Innovation Research survey. Innovators Statues went to the best companies in the most dynamic sectors of the economy, among others, pharmacy, energy, industry, construction, telecommunications, finance and science.


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Polpharma is a partner of Academic Career Fair

16 October 2014

Polpharma is a partner of Tri-City Academic Career Fair which will be held on Oct 23rd at the University of Gdansk.

The organizers of the fair are Career Offices of Pomeranian Universities: University of Gdansk, Gdansk University of Technology, Academy of Physical Education and Sports, Medical University of Gdańsk, Naval Academy, Maritime University.

We warmly welcome students and university graduates to visit Polpharma’s stand, where you will be able to check current vacancies, available programs, practices and internships, and learn more about the company.

Polpharma employees will also inform students and graduates in biotechnology and related fields about opportunities to participate in the recruitment for a year internship in Polpharma Biologics laboratories in Gdańsk Science and Technology Park. For those already interested in the internship:

Apply

The fair will take place on October 23rd form 9 AM till 5 PM at the Faculty of Law and Administration of University of Gdansk, Gdańsk-Oliwa, Bażyńskiego 6.


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Press conference

10 July 2014

Polpharma completed the phase II of Polpharma Biologics labs. In relation to this event, Polpharma organized press conference held on 24th of June. We invite you to watch video summarizing the meeting with journalists.

The opening of the II phase of the investment

03 July 2014

Polpharma completed the phase II of its Biologics labs, located in Gdansk Science and Technology Park. In these world class biotech laboratories the company is developing biosimilars, which will provide more affordable drugs for modern treatments of patients in Poland, and around the world.

The Polpharma Centre located on a 2.600 m2 area, includes development laboratories and installations for the production of biosimilars in accordance to GMP standards (Good Manufacturing Practice). It employees currently 40 high class specialists and is further growing.

Biopharmaceuticals - as opposed to drugs obtained by chemical synthesis - contain substances produced by living organisms (bacterial, yeast, mammalian cells). Their greatest strengths are breakthrough mechanisms of action, favourable safety profile and high efficiency, especially in the case of serious illnesses, such as cancer or immune-mediated diseases (rheumatoid arthritis, psoriasis, multiple sclerosis). The main obstacle to widespread their use is their high price (25+ times higher than chemical drugs). For this reason, biological drug therapy remains unavailable to many patients.

"Biologics are undoubtedly the future of medicine and as a result we decided to develop biosimilars. We are already developing three products of this type. We will provide a broader access to modern therapy to more patients" - explains Jerzy Starak, the Chairman of Polpharma's Supervisory Board.

In comparison to the chemically synthesized drugs, development of biosimilars is a long, complicated and expensive process. It lasts 7 to 9 years and costs $100 to 200 mio. Therefore we took an opportunity to join forces and form a strategic partnership with the German pharmaceutical group belonging to Thomas Strüngmann, a pioneer ans successful entrepreneur in the pharmaceutical industry.

Polpharma is also committed to build scientific consortia and biotech hubs, which will contribute to the development of innovation and Pomeranian region's economy. It is intended to create an industry-academia cooperation with the support of EU funds thererby leveraging knowledge and network of the Gdańsk scientific community.


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Polpharma expands its investment in biotechnology

11 June 2014

Polpharma has signed an agreement to jointly develop and commercialize biosimilar products. The company's partner in the joint venture is Neuraxpharm Group owned by Strüngmann family.

In order to speed up the work on high quality biosimilars and open up the possibilities for additional development, manufacturing and global commercialisation, Polpharma teamed up with a strategic German partner, the Strüngmann Group, which has vast experience in the field of biological drugs. Within the framework of this collaboration, both partners will share the costs and risks related to the development of biosimilars, and have equal rights to future products.

"This is a very important step for our company as it will speed up our development and, more importantly, it will give many gravely ill patients access to efficacious treatment with biosimilar products. The founding of the joint venture is also a starting point for possible extended cooperation with the Strüngmann Group in the field of innovative biological products," says Jerzy Starak, Chairman of the Supervisory Board of Polpharma.

Polpharma, a leading Polish pharmaceutical company specialised in branded generic products, took the strategic decision to enter the biosimilars market. Biosimilar products are considered to be the future of modern pharmacotherapy due to their high efficacy and safety profile, particularly in the treatment of cancer and immune system disorders. In December 2012, the company opened Poland's largest research and development centre at the Gdansk Science and Technology Park where it already develops various biosimilar products.


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Poland’s largest Biotechnology Centre

25 February 2013

Polpharma SA has completed Stage 1 of the construction of Polpharma Biologics, a state-of-the-art research and development centre in the Gdańsk Science and Technology Park.

Based in the new centre, the company will work on biotechnology, biosimilar and bioimproved drugs with a view to increase the access of patients who suffer from immune system and nervous system diseases and cancer to efficacious therapies.

Laboratories have been established in part of the centre which is ready with an area of 600 m2 to develop and optimise protein production processes from the original concept through the laboratory phase to the pilot plant scale. Furthermore, analytical laboratories opened in which product quality control can be ensured during production processes and finished drug forms can be evaluated. The most modern equipment is available in the Centre, necessary to ensure efficient work with complex high-molecular weight proteins, such as monoclonal antibodies. The whole investment with an area of 2,300 m2 will include pilot plant installations in the cGMP system (current Good Manufacturing Practice).

The Centre is the largest facility of this kind in Poland. The Staff currently includes 13 specialists with the target number being approximately 50 and possibly more. The Centre is an opportunity for the best young researchers who will work together with experienced biotechnology experts. Furthermore, the Company emphasises the importance of co-operation with academic centres both with respect to scientific activity (Medical University of Gdańsk) and to training future biotechnology experts to work in Poland’s businesses (funding a new Business in Biotechnology post-graduate programme at the Jagiellonian University).


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Recruitment to a postgraduate course “Business of Biotechnology”

31 July 2012

Do you want to start or are you already running a business in life science? Do you want to have a career in this field? Jagiellonian University and the Jagiellonian Centre of Innovation are now recruiting students to a new, elite postgraduate course “Business of Biotechnology”.

Polpharma Biologics is a program partner of the course and it offers paid internships to the best students.

The purpose of the course is to educate a group of managers and scientists prepared to run companies dealing with life science business, with particular emphasis on biotechnology. Therefore, the classes will focus on topics related to organization and management of a company and implementation of technology transfer processes and innovation management.

Participants will work in small groups mainly on case studies, so that they can learn practical ways to solve problems. An important asset of this course is an opportunity to gain valuable contacts. 80% of lecturers are practitioners, managers and members of senior management, including Piotr Lassota, R&D Director at Polpharma Biologics and Piotr Zień, R&D and Project Manager at Polpharma Biologics. Additionally, three best students will be offered 1-year paid internships by Polpharma Biologics in its newly established R&D centre in Gdańsk.

Recruitment will continue until 24 September 2012. Classes will start in October and they will last until July 2013. Detailed information about the course www.jci.pl/studia


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Polpharma Biologics at the BIO International Convention in Boston

22 June 2012

Polpharma Biologics, along with the Gdańsk Science and Technology Park and the Pomeranian Special Economic Zone, represented the Pomerania region at the BIO International Convention in Boston, USA.

Representatives of science and business spent three days at the Polish Pavilion presenting their potential in the biotechnology area.

The biotechnology sector is one of the leading industries in the Pomerania province. This is evidenced by dynamic enterprises and medical institutions, alongside three institutions of higher learning forming the biotechnologists of the future. An important role in the development of biotechnology in the region is also played by the Gdańsk Science and Technology Park GSTP, which has become a true port for companies in the biotechnology sector. It is here that Polpharma Biologics is constructing its Research and Development Center. The Center's total area will be over 2000 sq. m. It will employ 50 specialists in areas such as molecular biology, analytics, protein production process development, and other areas of biotechnology.

BIO International Convention was a unique opportunity to show the potential of Polish biotechnology on international markets, as well as to establish valuable contacts with potential investors, scientific and technological partners. The conference was preceded by Welcome to BIO-Poland, during which Piotr Lassota, R&D Director of Polpharma Biologics, participated as a representative of the Polish biotechnology sector in a discussion panel where he spoke about the challenges facing Polish pharmacy and biotechnology.

“During the conference we attended a lot of meetings and discussions with potential partners from around the world,” said conference participant Krystyna Giełdon, Head of Strategy and External Partner Cooperation at Polpharma Biologics. “Because of the conference's location in the capital of Massachusetts, for years one of the homes of American biotechnology, our attention was naturally drawn to companies located in that region. We conducted an all-day discussion with one of them in the company's headquarters. There were also many Chinese companies, which are the subject of our intense interest as we are seeking cooperation models that would give Chinese society access to our products fulfilling the high quality standards of the European Union,” adds Krystyna Giełdon.


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Biotechnology grants have been assigned

23 May 2012

Within the framework of a competition organised by the Polpharma Scientific Foundation, 2 research projects in biotechnology have received grants for implementation.

Every year, the Polpharma Scientific Foundation announces a competition for funding research projects in pharmaceutical and medical sciences. The subject of the last year’s 10th edition was "Biotechnology: the innovative methods of synthesis and drug dosage and analysis of its effectiveness". By the decision of the Foundation Management Board, as recommended by the Scientific Council, two grants for project implementation were assigned in that edition.

The winning projects are:

1. Dr Krzysztof Milewski, American Heart of Poland SA
Project title: "Development of an everolimus delivery system based on biodegradable nanospheres in order to limit neointimal hyperplasia following implantation of a coronary stent".

2. Dr Katarzyna Oszajca, Medical University in Łódź
Project title: "An assessment of prokaryotic addiction modules in the context of the search of novel immunotoxins".

For more information about the Polpharma Scientific Foundation and the competition for funding research projects in pharmaceutical and medical sciences, see http://www.polpharma.pl/en/scientific-foundation/.

The Polpharma Scientific Foundation was founded by Polpharma SA Pharmaceutical Works in Starogard Gdański in 2001. The Foundation’s mission is expressed by the slogan – We Help People of Science. The funds for the Foundation’s statutory activity originate in total from the Polpharma’s budget. The competition for funding research projects in pharmaceutical and medical sciences is the most important programme implemented by the Foundation.

More than 500 applications for research projects have been already received in ten editions of the competition. Fifty-seven research teams originating from both university centres and research institutes have received the grants. Implementation of 44 projects has been completed and their results have been published in renowned scientific journals.


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Dr Katarzyna Oszajca, research grant laureate, about her project

23 May 2012

The author of the winning project in the 10th edition of the competition of the Polpharma Scientific Foundation for funding research projects talks about the benefits from the studies implemented within the framework of this project.

Author: Dr Katarzyna Oszajca of the Medical University of Łódź
Project title: "An assessment of prokaryotic addiction modules in the context of the search of novel immunotoxins".
Grant value: PLN 96,000

Treatment of cancer with cytostatic agents is the mainstay of treatment in disseminated cancer and an adjunctive method of treatment in limited cancers with metastases. The currently used chemotherapeutic agents are still not perfect despite their clinical success. The main problem associated with chemotherapy is its low specificity, which means that most antineoplastic agents are non-selective and therefore damage rapidly-proliferating healthy tissues, such as the bone marrow, epithelial cells, immune cells and gametes. The resulting injuries lead to such abnormalities as haematological disorders, mucosal ulcerations, alopecia, immunosuppression, reproductive toxicity, and may also cause de novo mutations, which may potentially induce the development of further tumour cells. Immunotoxins are an important class of drugs that is being extensively investigated. Immunotoxins are hybrid proteins composed of cytotoxic fragments and a part responsible for selective binding to tumour cells. In our project, we will be testing a novel class of immunotoxins, whose catalytic components are made up of small prokaryotic toxins of addiction systems (toxin-antitoxin). In nature, these systems are responsible for negative selection of cells characterised by a damaged or incomplete genotype. Additionally, these modules possess a natural and highly specific inhibitor, antitoxin, which protects healthy cells.

The study will be a starting point for the development of novel antineoplastic drugs characterised by a higher specificity. Due to the size of the toxins intended to be tested we also expect them to be less immunogenic. Additionally, the cytoprotective component may reduce the side effects of the immunotoxin used.


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Dr Krzysztof Milewski, research grant laureate, about his project

23 May 2012

The author of the winning project in the 10th edition of the competition of the Polpharma Scientific Foundation for funding research projects talks about the studies on a new method of preventing restenosis after metal stent implantation.

Author: Dr Krzysztof Milewski of the American Heart of Poland SA
Project title: "Development of an everolimus delivery system based on biodegradable nanospheres in order to limit neointimal hyperplasia following implantation of a coronary stent".
Grant value: PLN 391,520

The most common treatment for ischaemic heart disease is percutaneous transluminal coronary angioplasty combined with implantation of coronary stents, particularly stents that release antiproliferative drugs (drug-eluting stents [DES]), which effectively reduce the risk of recurrence of artery narrowing (restenosis). Unfortunately, numerous studies have shown that DES, particularly first-generation DES, may impair healing of the arterial wall, mainly in response to the stable polymers on the stent surface whose role is to store drugs and control their release over time.

The aim of the project is to develop a new method to prevent restenosis following a bare-metal stent implantation based on intramural delivery of everolimus, the antiproliferative drug. Experimental and clinical studies have unequivocally demonstrated the efficacy of everolimus in reducing the risk of restenosis accompanied with the maintenance of a good safety profile. In order to further increase the safety and efficacy of the method everolimus will be packaged into nanospheres, or special bubbles made from a biodegradable polymer that dissolves over a prespecified time. The nanospheres will be delivered to the artery using a special transporting catheter whose efficacy and safety have been confirmed in experimental and clinical studies. This method will ensure an appropriate and time-controlled drug concentration in the coronary arterial wall and, as is the case with DES, will reduce the risk of restenosis. The delivery of the biodegradable nanospheres directly into the arterial wall will eliminate the adverse long-lasting reactions to the stable (non-biodegradable) polymer, theoretically reducing the risk of adverse clinical events by facilitating arterial healing. The project consists of a preliminary phase during which the nanospheres will be prepared and an experimental phase which will assess the pharmacokinetics of everolimus delivered into the artery in the form of nanospheres and its biological effects.

Positive results of the study will allow to test the method in clinical studies. It is being assumed that similarly to the DES technology, the method of local delivery of everolimus-containing nanospheres will significantly reduce restenosis rate and ensure a rapid and correct healing of the artery and shorten the duration of mandatory dual antiplatelet (“blood-thinning”) therapy that is required following these types of procedure.


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Polpharma Biologics on Bioconnect

11 May 2012

On 15-16 May the Bioconnect conference will be held in Poznań, at which entrepreneurs and experts from the industry of biotechnology and Life Science will discuss the condition of Polish biobusiness.

A lecture by Piotr Lassota from Polpharma Biologics will inaugurate the conference.

In his lecture on the cooperation between biotechnology and the pharmaceutical industry, Piotr Lassota, Director of R&D Polpharma Biologics, will evaluate the expectations of stakeholders and actual conditions of fulfilment of those expectations.

Other speakers invited, experts from the Western and Central European countries, will talk among other things about the latest scientific and business trends in personalised and regeneration medicine, development of new drugs, bioinformatics, or nanobiotechnology. More information about the conference may be found at www.bioconnect2012.pl.


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Polpharma Biologics at BioForum 2011

17 May 2011

The Biotechnology Unit of Polpharma partnered with Bioforum 2011, the largest biotechnological event in central Europe, which took place in Łódź on May 11th and 12th of 2011.

During this event representatives from Polpharma Biologics discussed partnership opportunities in pharmaceutical R&D with biotech companies and academic research centers.

A great number of students and graduates of biotechnology programs visited our stand and filled applications forms for joining our R&D Center in Gdańsk.

The director of the Polpharma Biologics, Dr. Piotr Lassota, together with other members of participating business took part in a jury of the BioCompetition. This was a contest for young scientist where contestants shared their innovative ideas by delivering short presentations, and answering questions from the Jury. The most promising project was presented by Mr Łukasz Orzechowski who won the first place in the competition.


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Completion of the conceptual planning phase of the Research and Development Centre

06 May 2011

The Research and Development Centre of Polpharma Biologics, planed to be fully operational in the first quarter of 2012, has just completed the conceptual planning phase.

What it means, is that the architects are now working together with our engineers on a detailed execution plan which will guide the contractors building our Labs. This process is scheduled to be completed by June 15.

The Centre is located in a brand new building of the Gdansk Science and Technology Park (GPN-T) in Gdańsk. It occupies 2,000 m2, what constitutes basically the entire ground floor of the building. It will support all Polpharma activities related to discovery and development of biological medicines, from innovative approaches based on current cutting edge science, to biobetters and biosimilars (follow-on biologics). It will also include process development as well as a cGMP scale-up facility, which will allow manufacturing of clinical batches of biological products.

In the meantime Polpharma Biologics have already begun the recruitment process for key positions there. “These are very exciting times for all of us at Polpharma, and we invite you to share that excitement with us by joining our R&D Efforts in Biologics.” says Dr. Piotr Lassota, Member of the Polpharma Trade Office Management Board, responsible for scientific supervision, development and project management for biotechnology based products at Polpharma.


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Polpharma Biologics

Gdansk Science & Technology Park
Trzy Lipy 3 building A
80-172 Gdańsk / Poland
T: +48 58 770 95 00
E: office.biologics@polpharma.com

Media Contact
Magdalena Rzeszotalska
rzecznik@polpharma.com

Polpharma Group

Pharmaceutical Works
Pelpinska 19
83-200 Starogard Gdański/ Poland
T: +48 58 563 16 00
F: +48 58 562 23 53
www.polpharma.pl

Media Contact
Magdalena Rzeszotalska
rzecznik@polpharma.com

We would like to encourage all companies as well as academic research centers interested in collaborating with Polpharma Biologics, to contact us.

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Zapytanie ofertowe 01/03/2014
03 marca 2014
dot. Oferty cenowej na rezerwację powierzchni i budowę stoiska firmowego na targach Bio International Convention 2014



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Location – Gdańsk, Poland

10 km from Gdańsk international airport
5 km from a Gdańsk City Center
30 km from a major Polish seaport in Gdańsk and Gdynia