The production of pure crystals is a method that is normally used for the determination of the spatial structure of a protein using X-ray defraction. Crystalline proteins have a very regular structure, meaning that contaminations can to a large extent be excluded. Therefore, protein crystals only contain a small number of foreign substances, which makes them a lot more stable in solution than proteins are. Due to the aforementioned properties, crystallisation opens up a broad range of applications in industrial protein purification processes. For example, the method can be used for the purification, formulation or storage stabilisation of proteins.
SYMBIOSIS, the new business unit of Heidelberg-based Biopharm GmbH, offers a wide range of analytical services, including tests, detection methods and methodological innovations related to the development of classical pharmaceuticals and biopharmaceuticals. SYMBIOSIS is a GMP- and GLP-certified provider of analytical services with long-standing experience and know-how that combines high-quality, state-of-the-art methods and solutions for its life sciences industry clients under one roof.
Vetter Pharma Fertigung a Ravensburg-based specialist in the production of aseptically pre-filled injection systems is strengthening its commitment to the North American market. Laupheim-based Rentschler Biotechnologie a contract research organisation that has been continuously expanding since 2006 has further investment plans.
On September 25th Vetter a specialist of aseptically pre-filled application systems officially opened its new Ravensburg South Mariatal production plant. 2800 guests were invited to the official launch and the company also publicised further important financial highlights over the last five years Vetter has been able to increase its sales volume by 70 million euros to 250 million euros.
On 1st December 2009, the Ravensburg-based contract manufacturer Vetter dedicated its new production facility which will focus on early clinical projects. At the new site in Chicago, Vetter Development Services USA, Inc. will fill very small quantities of product required for pre-clinical through Phase IIb projects. Phase III projects and commercial large-scale production will in future be conducted by the company’s German facilities in Baden-Württemberg. The company estimates that its new facility in the "Illinois Science and Technology Park" will start clinical filling by the end of 2010.
Amgen Inc. and Boehringer Ingelheim today announced they have signed an agreement under which Boehringer Ingelheim will acquire Amgen’s rights in substantially all assets at Amgen’s Fremont California development and manufacturing facility.
Atoll GmbH has developed a miniaturised chromatography platform that facilitates and accelerates complex biopharmaceutical production processes. Process developers from research and development laboratories around the world appreciate the time and cost savings that can be achieved with Atoll’s chromatography tools as well as the technology’s ability to specifically isolate sought-after compounds. The current huge demand for this technology means that the Weingarten-based company’s 15-member team can now move onto the next stage of development by investing in new cleanrooms.
BioRegionUlm recently announced the launch of BioPharMaXX at a meeting held in Ummendorf castle (close to Ulm). The acronym refers to a cluster focusing on biotechnology, pharmacy and medical technology that was selected as one of twelve regional clusters in a state-wide contest in Baden-Württemberg in 2008. Company representatives and researchers presented projects to improve the time-consuming and costly protein purification process used in biopharmaceutical production. The projects that were selected for funding were all representative of the BioPharMaXX cluster’s mission, namely to systematically reinforce the region’s strength.
The goal of many projects focusing on the purification of recombinant proteins is to rapidly and effectively remove substances and side products that would compromise the quality and quantity of biopharmaceutical compounds. A consortium of industrial and scientific partners is currently focusing on a different step in the biopharmaceutical production process: the goal is to keep as many as possible of the drugs’ ‘attachments’. The project focuses on sialic acids attached to the sugar residues of drugs.
The 2nd Laupheimer Zelltage conference organized by Rentschler Biotechnologie GmbH in Laupheim on 11th and 12th June 2012 focused on “Bioprocess light”. Twelve experts from applied research institutions and biotech companies from Germany and abroad provided the 200 or so guests with information on how modern bioproduction methods can be made simpler, more robust, cheaper, more reliable and hence more competitive.
The Laupheim-based contract manufacturer Rentschler Biotechnologie GmbH is greatly expanding its production capacities. The company is investing €24 million in the construction of two 3,000 litre stainless steel bioreactors, which should be operational in early 2017 and will more than double the production capacities for cell culture-derived proteins. Rentschler also announced recently that it was adding a new 2,000 litre single-use bioreactor that will be operational at the end of the first quarter of 2015. Dr. Christoph Winterhalter, Vice President Business Development & Sales at Rentschler Biotechnologie, talked with Walter Pytlik (BioRegionUlm) about the company’s investment and production plans.
The German biopharmaceutical industry has come through 2009 without experiencing too many major slumps. The roaring growth of the biopharmaceutical industry in previous years has been replaced by more moderate growth. This is the result published by the 4th Medical Biotechnology report in 2010 compiled on behalf of the biotech interest group of the vfa bio Association of Research-Oriented Pharmaceutical Companies by the Boston Consulting Group.
Dr. Aziz Cayli knows CHO (Chinese hamster ovary) cells so well that he decided to establish his own company in 2005. Prior to establishing CellCa GmbH in the city of Laupheim, Cayli held posts at Roche in Penzberg and Boehringer Ingelheim in Biberach. CellCa is a specialist in upstream processing and with its current total of 15 staff, the company achieved revenues of around two million euros in 2009. We talked with Dr. Aziz Cayli who did his doctorate on the metabolism of CHO cells.
A symposium on “Cell Factories of the Future” was held at the Laupheim-based company Rentschler Biotechnologie on 14th and 15th October 2010. The event attracted around 70 scientists from academia and industry and will now take place every two years. The symposium focused on new biomanufacturing developments and technologies, and included lectures on (animal) cells, cell factories and the future of recombinant protein production.
The young Swiss company Kenta Biotech will work with the Laupheim-based contract manufacturer Rentschler to develop a fully human monoclonal antibody against methicillin-resistant Staphylococcus aureus (MRSA).
Vetter, a leading provider of aseptic prefilled drug-delivery systems, announced that its Chicago facility is accepting client projects. Located at the Illinois Science + Technology Park in Skokie, Illinois, the site supports preclinical through phase II products.
According to a recent announcement by the Bavarian patent exploitation agency of universities and higher education institutions, the pharmaceutical company Boehringer Ingelheim has acquired the rights for a therapeutic antibody development and manufacturing process.
Biopharmaceuticals are one of the best selling drugs. The majority of successful biopharmaceutical ingredients are produced in CHO cell lines. Strong competition forces biopharmaceutical producers to continuously improve the drug development process and the production methods, which requires highly qualified experts.
As blockbuster biopharmaceuticals go off patent, biosimilars are increasingly competing with them for a market share. However, the production of biosimilars is rather complex and costly. The approval of biosimilars is also subject to many hurdles. Their introduction to the very expensive biopharmaceuticals market is often associated with marginal price reductions.
Before electronic solutions existed lorries were needed to ship new drug applications which often comprised 500000 or so pages. Thanks to IT this is no longer necessary. IT-based procedures and solutions are playing an increasing role in all areas of the pharmaceutical industry. Markus Roemer CEO of Ravensburg-based comes compliance services supports companies in implementing legal guidelines in this area. In the following interview Roemer talks about new developments related to paperless production processes and the challenges that these developments represent for companies.
The speed dating format is no longer just a popular and simple dating method for lonely hearts, but has also become a rewarding way for establishing new business contacts and connections quickly and efficiently. BIOPRO Baden-Württemberg chose speed networking, as speed dating is called in the corporate world, for its recent Meet & Match event on pharmaceutical process technology, which took place on 15th March 2016 with the support of Bosch Packaging Technology in Crailsheim.
A festive atmosphere in the life sciences research building on the Ulm University Campus: on Wednesday 19th October, Ulm University and Boehringer Ingelheim signed a research cooperation agreement. The cooperation between academia and industry is also being supported by the Baden-Württemberg government. The new alliance is called “Boehringer Ingelheim Ulm University Biocenter” (BIU) and the funding volume is around 4.5 million euros for an initial period of three years.
Europe is the leader in the global biosimilars business. The prospects are excellent as the patents of many innovator biopharmaceuticals, including therapeutic antibodies, have reached or are about to reach patent expiry. The profitable, though difficult biosimilars market, is increasingly dominated by a handful of financially strong companies.
Merck Serono, a division of Merck, Darmstadt, Germany, announced on 10th Oktober 2012 during the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) congress in Lyon, France, that the company has initiated a new global research award to improve understanding of multiple sclerosis for the ultimate benefit of patients.
The Hannover Medical School (MHH) and Rentschler Biotechnologie GmbH have signed a licensing agreement for the commercialization of a vector system for gene therapy that promises significant therapeutic and economic advantages over conventional technologies. Rentschler, an experienced specialist in the development of cell culture-based manufacturing processes and the production of relevant biopharmaceuticals, attains the right to develop packaging cell lines containing the novel vector and to use these commercially for the contract manufacturing of gene therapeutics.