Heidelberg
The Institute for Recombinant Protein Research & Development
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Octapharma Biopharmaceuticals (OBP) is Octapharma's pharmaceutical research and division, with sites in Heidelberg, Frankfurt and Berlin. The team is focused on producing recombinant drugs in the fields of haemophilia, immunology and critical care.
Various research platforms are used in lead discovery to explore and develop innovative biopharmaceuticals. These are used, for example, to produce natural and half-life extended coagulation factors, as well as in the development of specific, tailor-made biomolecules in our three therapeutic areas.
The development of our biotherapeutics is supported and accelerated by the application of the latest in-silico modelling and automated high-throughput processes.
Our history
Find out more details about the 10-year history of our Heidelberg site.
1997
Octapharma Biopharmaceuticals GmbH was founded in Munich in 1997. With the increasing importance of recombinant research, the original IZB site in Martinsried near Munich no longer offered the necessary space for future expansion.
Foundation of the research site Molecular Biochemistry Berlin.
2009 - 2010
Since the former location in Martinsried near Munich no longer met the requirements and although alternatives in Munich were also considered, founder, CEO and Chairman of the Board of Octapharma AG - Mr. Wolfgang Marguerre - as a native of Heidelberg, decided that his hometown was the ideal location for the new state-of-the-art research and development center. Thus, a plot of land was acquired in the Technology Park in 2009.
2010
On July 8, 2010, the foundation stone for the new research center of Octapharma Biopharmaceuticals GmbH in Heidelberg was laid on the outskirts of the Heidelberg Technology Park.
Here, after the move from Martinsried near Munich, basic research for the fields of hematology, immunology and intensive care medicine will continue to be pursued at the highest level.
2011
Life science meets construction
The new research center with an investment of 25 million euros will house office and conference rooms as well as laboratories for research and development and for the clinical production of new drug developments.
2012
The new research center, with an investment of 25 million euros, offers space for both offices and conference rooms, laboratories for research and development, and clinical production of new drug developments on a site area of 4,500 m² and a floor area of over 10,000 m².
2013
Development of a half-life-extended G-CSF (granulocyte colony stimulating factor).
First GMP inspection at the Heidelberg site.
2014 - 2016
In-depth biochemical characterisation of Nuwiq®, in particular its post-translational modifications for successful approval in 2014.
Approval and market launch of Nuwiq®, the first recombinant coagulation factor VIII from human cell lines.
Merger of the Frankfurt, Berlin and Heidelberg sites under Octapharma Biopharmaceuticals GmbH.
Manufacturing authorisation & GMP certificate from the Regierungspräsidium Tübingen.
2017 - 2018
Start of automation projects - installation of the first robot in R&D (Research and Development Department).
Canteen opening
2019 - 2020
Implement a cloud-based data management system that supports big data processing and manages the various requirements for large molecule therapeutics development workflows.
Conversion to green electricity
2021 - 2022
Successful GMP inspection by the Tübingen Regional Council and the Paul Ehrlich Institute.
Development of a recombinant blood coagulation factor VIII for subcutaneous administration 2021.
Establishment of two research platforms to be operated in parallel, 2021
Establishment of robot-based high-throughput screening procedures 2021.
2021 - 2022
10th anniversary of Octapharma Biopharmaceuticals GmbH in Heidelberg.
Introduction of in-silico modeling methods for the development of specific biopharmaceuticals 2022.
Übrigens…
“Freu dich, du bist in Heidelberg!”
Heidelberg is a picturesque and charming city in southwestern Germany known for its rich history, stunning architecture and natural beauty. The city is nestled in the Neckar River valley and has been a popular destination for tourists and locals alike for centuries.
Heidelberg is home to several historic sites, including the impressive Heidelberg Castle, the Old Bridge, and the Church of the Holy Spirit. The charming cobblestone streets and architecture of the Old Town invite visitors to explore it on foot. Heidelberg's is surrounded by rolling hills and dense forests and offers numerous opportunities for outdoor activities.
Heidelberg is a melting pot of different cultures and ideas, and despite this, or perhaps because of it, an international city of research and science.
Founded in 1386, the Ruperto Carola is the oldest university in modern Germany and one of the most research-intensive in Europe.
Heidelberg site
Expertise and creativity
“We are firmly integrated in Octapharma's strategy for the future and develop recombinant proteins with various platforms. Our dedicated, motivated colleagues pool their expertise from a wide range of specialist departments for this purpose. Our focus is always on our patients.”
Torben Schmidt, General Manager
Training & development
“I am very glad that I got the chance to start my career here at Octapharma. I really appreciate that there is a special focus on training and development here. I really like the easy cooperation between the different departments and the general atmosphere in my working environment at Octapharma.”
Iva Pavicic, Production Specialist USP
Encourage and challenge
Since joining in 2018, I have had the opportunity to grow at our Heidelberg location through the encouragement of my supervisors. Our direct communication, wide range of tasks and close cooperation between departments makes our location an exceptional workplace full of innovations.
Dr Jan Caspar, Head of QC Incoming
Goods & Microbiology
Family values
“My responsibilities as HR Manager are very varied and diverse. I am happy to take on responsibility at Octapharma and to be able to actively help shape the company's path. It is simply fun to work in a team with motivated colleagues and to make a difference together. I appreciate the pleasant working atmosphere and the open, trusting and appreciative interaction within the company.”
Dorothee Schaupp, HR Manager
The goal firmly in sight
“For scientists, it is a very special privilege to be able to contribute to patient well-being with their own research. As part of Research and Development, I am committed to bringing together the ideas, expertise and skills in our team in a targeted and deliberate way so that patients can benefit from innovative approaches.”
Dr. Thomas Güttler, Head of R&D
What we offer
As a successful and employee-oriented company, we offer our employees a collegial working environment and various social benefits, such as an employer-funded company pension plan, employer-funded accident insurance, a job ticket, company bike leasing, health benefits, free drinks and fruit, a modern canteen with a discounted and diverse selection of freshly cooked food, and employee events.
The steady growth of our research and development site in Heidelberg offers our employees a wide range of opportunities. These can include taking on management tasks or working as a specialist.
Extensive training opportunities are part of Octapharma's corporate philosophy and round off the offer.
Our departments
Our departments work in compliance with Good Manufacturing Practice (GMP) guidelines and thus meet the highest quality and safety requirements. We operate research and development laboratories, production of clinical trial material (drug substance) in a GMP pilot plant and quality unit. Currently, the total building area is 10,000 m².
To give you an idea of what this means exactly, we have briefly summarized the tasks of each department.
Research and development
Our R&D unit researches and develops recombinant proteins for use as new active substances in the fields of hematology and immunotherapy. Together with our colleagues at the Berlin site, eight R&D teams in Heidelberg are working towards the goal of offering innovative drugs to our patients.
Research and development
Our focus is on the continuous improvement of patient-critical product properties, such as half-life extension of the drug or the development of mimetic products with improved immune tolerance. Here, we rely on state-of-the-art technologies supported by our high-end robotic platforms.
Research and development
In addition to lead discovery - the search for initial drug candidates and their further development - our R&D unit also covers all other steps of preclinical research and development. This includes cell line development, process development both upstream and downstream as well as the development of formulations and analytical methods.
Research and development
The fact that pilot production is also located in-house also expands the range of tasks of the R&D unit. The processes and methods developed are therefore tested for GMP suitability and then transferred to colleagues in pilot production and quality control - an essential prerequisite for starting material production of the final drug candidate for clinical trials.
Research and development
In close cooperation with pilot production, the R&D unit continues to support with accumulated knowledge from process development and continuous generation of additional data to ensure a smooth upscaling of the production process.
Research and development
Furthermore, the unit is involved in the preparation of regulatory documents for submission to EMA and FDA and also offers its scientific support to other parts of the Octapharma Group, for example in the life cycle management of already approved recombinant products.
Project Management
Project Management coordinates activities in recombinant research and development projects. In managing our projects, we focus on co-creating project plans and timelines with all stakeholders, sharing information, bringing people and ideas together, facilitating collaboration and decision-making, as well as engaging external stakeholders with an active project role.
Project Management
Our goal is to drive projects forward together to develop new products and ensure their safe and effective use. Our pipeline is broad and includes both the further development of current products and the application of new classes of active ingredients.
Pilot production
Our task is the GMP-compliant, biotechnological production of active ingredients for the supply of clinical studies as well as the development and establishment of new, innovative production techniques.
The tasks change depending on the project status. Each project begins with process transfer from development, associated with scale-up, process design creation and implementation, and GMP cell bank manufacturing.
Pilot production
The production of APIs for process and material characterisation and - later on - GMP-compliant API production for clinical trials is an essential aspect of our work.
We have about 500 m² of class C and D clean rooms at our disposal. For different projects, bioreactors of different sizes, hard-piped stainless steel and "single use" can be used. Purification is carried out using various biochemical and process engineering methods.
USP – Upstream Processing
Cultivation of mammalian cells in production volumes up to 100 liters is performed in bioreactors that can be operated in perfusion, batch or fed-batch modes.
Cultivation includes:
Preparation of GMP cell banks
Cultivation of cells and propagation
Cultivation of cell cultures with the aim of material production
DSP – Downstream Processing
Downstream processing of biopharmaceutical active ingredients refers to the recovery and purification of the drug substance (DS) from the cell-free cell culture supernatant. Generally, this involves a combination of different process steps.
DSP – Downstream Processing
"Harvest" and "Capture" step: separation of the cell supernatant from the cells and initial concentration and reduction of impurities.
Purification and removal of impurities and by-products.
DSP – Downstream Processing
Purity is increased with each successive method while retaining as much product as possible.
Concentration of the active pharmaceutical ingredient to the target concentration and re-buffering of the active pharmaceutical ingredient into the formulation buffer.
QC Analytics
The aim of quality control is to ensure product integrity, process accuracy and patient safety. In the quality control laboratory, samples from all stages of the manufacturing process are analyzed. For this purpose, modern and largely automated equipment is used, which is operated by specially trained and instructed employees. These tests, evaluation of the results, and trending ensure that irregularities are detected as early as possible and countermeasures can be initiated.
QC Raw Materials & Microbiology
The QC Raw Materials & Microbiology group in Heidelberg is dedicated to the quality control of raw materials and process media (e.g. water) used in Octapharma's biopharmaceutical production.
QC Raw Materials & Microbiology
In addition, we take care of the logistical processes related to incoming goods and warehousing in accordance with GMP. Furthermore, we monitor the production environment and maintain the hygiene concept in Heidelberg to play our part in the production of safe biopharmaceuticals.
Quality Assurance - QA
The aim of Quality Assurance (QA) is to ensure that GMP guidelines and applicable laws regarding drug manufacturing are adhered to in order to always be able to guarantee product quality and patient safety.
QA always works closely with the other departments.
Quality Assurance - QA
QA is responsible for supplier qualification, conducting (internal) audits, change and deviation management, and document management. It also ensures that all employees are adequately trained for the work in their area.
Technical Unit
The Technical Unit team, consisting of technicians and engineers, is responsible for looking after and ensuring the availability of facilities, utilities and process technology at the Heidelberg site.
In addition to planning and implementing maintenance and repair work on GMP and non-GMP facilities, this also includes the conceptual design, coordination and implementation of technical investment, replacement and optimisation projects.
Technical Unit
The Technical Unit is responsible for ensuring that all technical equipment complies with GMP guidelines and for preparing change control applications and deviations.
In addition, qualification tasks (DQ, IQ, OQ) are also performed within the scope of technical projects and optimisations.
Administration & IT
Accounting has the task of recording all changes in value in the company. It provides the basis for determining balance sheet ratios, cost of sales or other operational statistics.
Controlling has the task of supporting management in the implementation of corporate goals by means of a reporting system.
Administration & IT
The task of purchasing is to meet an existing demand at the best price, in the desired quality, in the appropriate quantity, at the specified time and in the right place.
IT is responsible for the maintenance and further development of the ongoing operation of our information technology and communications systems.
Administration & IT
The HR department is responsible for operational personnel management (payroll/salary accounting, time management, recruiting) and personnel development.
Contact:
Octapharma Biopharmaceuticals GmbH
Im Neuenheimer Feld 590
69120 Heidelberg
Tel.: +49 6221 1852 500
Fax: +49 6221 1852 510
E-mail address: info-heidelberg@octapharma.com