Application Releases

September 26, 2017 | SIRION Biotech and Vibalogics partner to offer complete Adeno-Associated Virus (AAV) services

Munich, Germany - SIRION Biotech GmbH and Vibalogics GmbH, have signed a strategic partnership agreement designed to meet demand from gene therapy companies for a start-to-finish AAV service.

The new service offering, which will be available from the beginning of 2018, will allow the two companies to cater to virtually all customer needs for viral vector services, from initial vector engineering and development to GMP production.
As part of the collaboration, SIRION Biotech will provide specialist AAV technology, while Vibalogics will act as its production partner for customers ready to progress to clinical trials.
Dr. Christian Thirion, CTO and founder of SIRION Biotech said: “This step will allow us to offer one of the most versatile and complete AAV services packages in the world and meet demand for a more streamlined development and supply process. We are looking forward to a partnership that will empower gene therapy companies to make sure that ingenious new treatments get to the patient without delay.”
Along with the expanded service offering, the companies will also establish new stringent quality levels for pre-clinical virus batches that will emulate Vibalogics’ GMP production methods. This strategy will ensure that pre-clinical research can be conducted with fully scalable products at ‘GMP-like’ quality, while maintaining cost and time efficiency.
Dr. Stefan Beyer, Managing Director of Vibalogics said: “We are delighted to enter into this partnership and be in a position to offer our customers a broader service than we can offer alone. We believe that this is a great opportunity for companies in the AAV field to benefit from a seamless transition from pre-clinical activities to clinical manufacturing.”
SIRION Biotech, based in Munich, is a virus engineering expert specialising in viral vector technologies. Using its team of specialists and expertise in the biotech industry the company carries out complex development projects to customize AAV dynamics and improve vector tropisms, safety and productivity.
Vibalogics, based in Cuxhaven in Germany, offers GMP manufacturing and development services for the biopharmaceutical industry and specialises in the handling and manufacture of viruses and live bacterial products for therapeutic and prophylactic applications. The company is one of the few providers of GMP compliant Fill&Finish services dealing with live viruses and bacteria. In addition to GMP manufacturing, Vibalogics offers process development, assay development and release testing services along with QP release of the clinical batch to complete the chain of activities.

ENDS
For further information, images and interview opportunities, please contact Kate Hindhaugh at ramarketing: kate@ramarketingpr.com | 0191 222 1242 | ramarketingpr.com | Twitter: @ramarketingpr | Facebook: /ramarketingpr | Linkedin: /ramarketing
SIRION Biotech GmbH
Am Klopferspitz 19
82152 Martinsried/Planegg
Germany
+49 89 700 961 99 9
or
Vibalogics GmbH
Zeppelinstraße 2
27472 Cuxhaven
Germany
+49 4721 565 400

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January 12, 2016 | Breakthrough technology improves genetic stem cell therapies

SIRION Biotech and Helmholtz Center Munich find answer to pressing challenges for gene therapy with their “Munich Solution”

With the beginning of a new fiscal year SIRION Biotech GmbH, located at the Innovation and Start-Up Center for Biotechnology in Martinsried/Planegg near Munich, reports an annual growth of 140% to 4 million Euros in revenue, and profitability - just in time to celebrate its 10th year in the business. Decisive for this success ...download text ENGLISH - GERMAN

December 21, 2015 | Breakthrough for preclinical vaccine vectors

New adenovirus serotype exceeds all expectations in first preclinical vaccination tests.

Munich, 21 December 2015, Ad19a, the latest in adenoviral (AV) gene vector innovations, has generated first data in preclinical vaccination tests – with most promising results. It demonstrated its ability to elicit robust immune response against a genetically coded antigen in a rodent model...read more ENGLISH...more in GERMAN


October 28, 2015 | Progress made with novel breakthrough vaccines: new production cell lines cope with difficult to express toxic antigens

Novelty at upcoming Bio Europe in Munich: SIRION Biotech announces high production yields with toxic antigens for vaccine production

Munich, 28 October 2015, very soon will there be novel breakthrough vaccines in the market. Associating vaccines with just prophylaxis is a thought of the past, increasingly, vaccines will demonstrate therapeutic effects specifically in the field of so far difficult to address tumor diseases (immune therapies).

A critical hurdle has in the past been making enough of the vaccine vector material. This is especially difficult if not impossible when critical antigens are toxic because they are of viral or bacterial origin as is the case for HIV envelope proteins and bacterial virulence factors. This occurs in the majority of cases.more...more in German....


August 07, 2015 | Progress Published in Screening for New Cancer Compounds in Context of Radiation Therapy

Helmholtz' Institute of Radiation Biology, SIRION Biotech an InSphero publish novel cell-based phenotypic assay

Munich, 07 August 2015, a recent publication by BMC Cancer discusses a comfortable 3D cell-based phenotypic assay enabling high throughput screening of compounds with radiation therapy modulating capacity, opening the field to drug discovery.

Radiation resistance presents a challenge to the effective treatment of cancer. If therapeutic compounds were capable of resensitizing resistant tumours then a concurrent chemo-radiation treatment could be used to overcome radiation resistance. more... more in German....


August 19, 2014 |Tissue specific optimized AAV Plasmids are now available to make research & therapy more targeted

Gene Therapy development progresses with tissue specific AAV Plasmidsdeveloped by Europe’s leading commercial supplier of viral vectors, SIRION Biotech in Munich.

Munich, 19 August 2014, viral vectors are a new class of biologics that help treat diseases caused by defective gene function / proteins (“gene therapy”). More than 20 companies worldwide the majority of which originate in the United States are applying viral vectors to conduct clinical studies.

A key hurdle when applying viral vectors is to limit the transduction (gene transfer) to the appropriate cells of a specific tissue without affecting their surrounding environment. But, how can an expression system differentiate between tissue or even cell type? SIRION Biotech, in cooperation with U of Munich (LMU) and U of Cologne, has developed a line of viral vectors with specific promotors that are only active in a specific set of targetetd cells to initiate the desired gene expression. Using this method, the gene of interest is only being expressed in the targeted tissue which is relevant for the desired therapy. This improves the effectiveness of the therapy and also addresses safety concerns by reducing the likelihood of side effects. more...


June 12, 2014 | Adenovirus Vectors meet critical FDA requirement regarding risk of contamination with infectious agents; a critical hurdle on their way to clinical studies can be overcome

SIRION Biotech has its viral vectors tested by SGS Vitrology for replication competent adenovirus (RCA)

Viral vectors present themselves as a new class of biologics that help treat diseases caused by defective genes / proteins (“gene therapy”). About 20 companies worldwide the majority of which originating in the United States are applying viral vectors to conduct clinical studies.

A key safety concern is the risk of transmission of infectious agents by inadequately tested products, specifically any replication competent adenovirus (RCA) still being administered to the patient. RCA comes from working with the most common production cell line used for replication defective adenovirus vectors, HEK293. Besides ethical concerns around HEK293, the cell line may complement the critical E1 replication gene that is lacking in the vector. The concern that RCA could lead to adverse events in patients led FDA to recommend limits on RCA levels in clinical lots of adenovirus vectors. more...


March 25, 2014 | Overcoming hurdles of HCMV vaccine development: Munich researchers claim progress

Recent patent publication introduces a viral vector that is both infecting endothelial cells and is eliciting an immune response

Munich, Infections by Human Cytomegalovirus (HCMV) are among the medically most significant herpesvirus infections. About 30 – 40.000 infants p.a. are born already infected in the USA alone, millions when including countries less developed. Individuals with a competent immune system cope with such infection, less so individuals that have experienced organ transplants or HIV. Such individuals then suffer life-threatening inflammatory diseases over and over again. The National Vaccine Committee of the US Institute of Medicine made an effective HCMV vaccine a highest level priority due to society costs in both morbidity groups.

No vaccine is commercially available, the therapy of choice is a single hit chemotherapy with known severe side effects. Searching for an effective HCMV vaccine has become a #1 priority in vaccine research.

more...


25. März 2014 | Fortschritte bei der Entwicklung eines Zytomegalieimpfstoffs: das Patent Münchner Forscher ist publiziert

Die jüngste Veröffentlichung eines Patents beschreibt einen viralen Vektor, der zugleich Endothelzellen der innersten Wandschicht befällt und die gewünschte Immunantwort auslöst.

München, Infektionen des humanen Zytomegalievirus (HCMV) gehören zu den medizinisch bedeutendsten Infektionen des Herpesvirus. Etwa 30 – 40.000 Neugeborene im Jahr allein in USA sind hiermit infiziert, Millionen bei Einbeziehung der weniger entwickelten Welt. Menschen mit einem gut ausgeprägten Immunsystem wehren eine solche Infektion ab, Menschen mit HIV oder Organtransplantationen weniger. Solche Menschen leiden immer wieder an lebensbedrohenden Entzündungskrankheiten. Das Nationale Impfstoffkomitee des Amerikanischen Institute of Medicine hat der Entwicklung eines wirksamen Impfstoffs gegen HCMV oberste Priorität eingeräumt.

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March 20, 2014 | Human Taste Sensation can now be investigated on a molecular level with stably proliferating Human Taste Cells

SIRION Biotech provides adenovirus to transduce proliferating-promoting genes to viable human taste cells from fungiform papillae

Munich,Chemical Senses by Oxford University Press posted a publication this week regarding stably proliferating taste bud cell lines for the study of the molecular mechanism of taste sensation. Researchers from near Frankfurt and Munich identified HTC-8 cells expressing bitter taste receptor genes. Bitter tastants triggered functionally distinct signaling pathways in such HTC-8 cells. SIRION Biotech was critical in generating adenovirus that helped transducing human taste cells such that they proliferate and maintain taste cell-specific properties and authentic responsiveness to taste stimuli.

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20. März 2014 | Menschliches Geschmacksempfinden jetzt im Labor erforschbar dank stabiler Modelle von Geschmackszellen

SIRION Biotech stellt entsprechende Zellmodelle bereitAmerikanische Diabetes Assoziation veröffentlicht neue Forschungsergebnisse zum BACH2 Wirkmechanismus bei Diabetes

München,Chemical Senses, ein Journal von Oxford University Press, veröffentlicht diesen Monat eine Publikation zu stabil wachsenden Geschmackszellen in vitro. Wozu? Zum nun möglichen Studium des menschlichen Geschmacksempfindens im Labor. Forscher aus Südhessen und München identifizierten sogenannte HTC-8 Zellen, die Gene exprimieren für bitteren Geschmack. Oder umgekehrt: bittere Geschmacksstoffe lösen einen entsprechenden Signalmechanismus aus.

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March 13, 2014 | SIRION Biotech’s adenovirus platform technology allows for overexpression of BACH2: BACH2 plays role in type 1 Diabetes by regulating pancreatic β-cell apoptosis

American Diabetes Association posts publication presenting clarification on the BACH2 mechanism to contribute to diabetes

Munich, SIRION Biotech provided successfully recombinant adenovirus containing the human BACH2 mRNA (GenBank: NM_021813) in a study meant to clarify an unexpected and relevant mechanism by which BACH2 may contribute to diabetes. The human BACH2 coding region was amplified by PCR from cDNA clone BC166613 purchased from Source Bioscience (Berlin, Germany). The BACH2 coding region was then transferred via recombination into plasmid pADCMV-DEST containing the genome of a replication deficient Ad5-based vector deleted in E1/E3 genes. The results by this study group around leading European scientists from Belgium, Italy & Spain is now being published by the American Diabetes Association, find link to publication here. More...


13. März, 2014 | SIRION Biotech ermöglicht die Überexpression von BACH2 mithilfe ihrer Adenovirus-Plattformtechnologie: BACH2 spielt eine Rolle bei der Entstehung von Typ 1 Diabetes

Amerikanische Diabetes Assoziation veröffentlicht neue Forschungsergebnisse zum BACH2 Wirkmechanismus bei Diabetes

München, SIRION Biotech entwickelte einen rekombinanten Adenovirus, der das humane BACH2 mRNA (GenBank: NM_021813) enthält und so eine Überexpression dieses Gens für Forschungszwecke ermöglicht. BACH2 ist ein mögliches Risikogen in Sachen Typ 1 Diabetes: BACH2 reguliert den Zelltod der Insulin produzierenden Beta-Zellen in der Bauchspeicheldrüse. Für die Überexpression wurde die humane BACH2 kodierende Region amplifiziert mit PCR vom cDNA-Klon BC166613 bezogen von Source Bioscience (Berlin). Im nächsten Schritt wird die Region mithilfe Rekombination transferiert in ein Plasmid, das das Genom eines ‚kastrierten‘ Adenovirus 5 basierten Vektors enthält. Die Ergebnisse dieser überwiegend europäischen Studie aus Belgien, Italien und Spanien wurden nun auf der Internetseite der Amerikanischen Diabetes Assoziation veröffentlicht. Der Link zu der Publikation befindet sich hier. Mehr....

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March 04, 2014 | German Helmholtz Zentrum Munich reports on Gene Transfer Optimization in 'Biomaterials' in cooperation with SIRION Biotech

Systematic improvement of lentivirus transduction protocols by antibody fragments fused to VSV-G as envelope glycoprotein

Neuherberg near Munich, Controlled gene transfer into different target cells by means of specific surface markers is significantly more efficient than gene transfer without this assistance. Gene therapies using lentiviral transfer of genetic information can thus be optimized. These findings were reported by scientists of Helmholtz Zentrum München in the ‘Biomaterials’ journal.

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04. März, 2014 | Helmholtz Zentrum München berichtet in 'Biomaterials' über die Optimierung von Gentransfer in Zusammenarbeit mit SIRION Biotech

Systematische Verbesserungen der Lentivirus-Transduktion mit Antikörperfragmenten gekoppelt an ein Glykoprotein

Neuherberg / München, Der gesteuerte Gentransfer in verschiedene Zielzellen erfolgt mittels spezieller Oberflächenmarker deutlich effizienter als ohne diese Hilfsmaßnahmen. Dadurch können Gentherapien – bei denen Lentiviren genetische Informationen transferieren - optimiert werden. Dies berichten Wissenschaftler des Helmholtz Zentrums München im Fachjournal ‚Biomaterials‘.

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December 19, 2013 | Viral vectors made in human expression system allow for safer and more efficient production of novel vaccines and gene therapy

SIRION Biotech licences rights to CEVEC Pharmaceuticals' immortalized suspension cells derived from primary human amniocytes for its range of viral vectors

Munich,Cologne,SIRION Biotech announced today it is now providing viral vectors for preclinical use to be expressed in CEVEC’s CAP®-Technology. CAP®cell lines are designed for stable and transient protein production and achieve highest protein yields with authentic human glycosylation patterns. Adenovirus and AAV vectors expressed in CAP®cell lines not only allow for higher yields, they also meet most stringent safety requirements when it comes to material to be used for clinical trials.

Press release in English and German


Sep 19, 2013 | Video illustrates principles of adenovirus transduction enhancement

Follow SIRION Biotech's latest release


May 8, 2013 | All critical types of viral vectors now from one competent source, both ready-to-use and custom made

SIRION Biotech GmbH adds lentiviral vectors to its vector portfolio

Munich,Germany, SIRION Biotech has taken a critical step in the company’s development towards a viral vector Center of Competence: all three major types of viral vectors used for sophisticated drug discovery are now available, either ready off the shelf or custom made.

The three important types of viral vectors are adenovirus (AV), adeno-associated virus (AAV) and lentivirus (LV): AV for transient gene expression, AAV for long-lasting in vivo expression, LV for stable genomic integration.

Press release in English and German


February 18, 2013 | Adenovirus Serotyp-Vektoren des Typs Ad19a für neuartige Gentherapien und Impfstoffentwicklungen sind jetzt breit zugänglich für Forschungszwecke

München,Adenovirusvektoren (Ad) repräsentieren ein neuartiges Wirkschema für eine Reihe von Anwendungen in Gentherapie, bei Impfstoffen und Virotherapie. Ihre klinischen Möglichkeiten waren in der Vergangenheit eingeschränkt durch bereits im Organismus gegen sie vorliegende Antikörperkonzentrationen. Dies gilt im Besonderen für die meistverwendeten Vektoren der sogenannten Serotypen Ad2 und Ad5, Variationen innerhalb der Subspezies der Viren.

Press release in German


February 18, 2013 | Ad19a adenovirus serotype vectors are now available for novel gene therapy and vaccine applications

Munich, Germany: Adenovirus (Ad) vectors are highly attractive for a wide range of gene therapy, vaccine and virotherapy applications. Vector efficacy in the clinical context, however, is limited by humoral response due to pre-existing titers of neutralizing antibodies against the vector itself. This applies particularly to the commonly used adenovirus serotypes 2 and 5.

Press release in English


December 04, 2012 |Adeno-associated virus now easily available for research and preclinical studies

Munich, Bielefeld, Heidelberg (Germany), SIRION Biotech and PlasmidFactory agreed to actively promote adeno-associated virus (AAV) vectors for advanced preclinical research. Dr. Oliver Mueller, University of Heidelberg, will serve as scientific advisor. AAV vectors have been identified as most promising gene delivery candidates for curative therapy of gene defects that need long-term treatment.

Press release in English


July 19, 2012 |European Patent Office publishes patent for the recombinant generation of adenoviral vectors paving the way for breakthrough gene therapies and novel vaccines

Munich, Germany, The European Patent Office published on 4 July 2012 a ground-breaking patent describing the cloning of adenovirus vectors of all serotypes.

The underlying technology applies bacterial artificial chromosomes (BAC) that allow cloning of rather large genome sequences. BAC’s are highly stable which is of specific interest to therapeutic applications. With the newly created cloning platform for all human and non-human adenovirus vectors it is now possible to easily modify all adenovirus serotype vectors and keep them stable.

Press release in English


March 21, 2012 | More effective drug screening now possible with in vitro cell models that come with their own reporter genes

SIRION BIOTECH launches SenCELLTMat Bio-Europe Spring in Amsterdam

Munich, Germany,SIRIONBiotech presents its new line of products under the new SenCELL™ brand for functionality testing in stable in vitro cell systems.

An example is SenCELL LifeActTMrepresenting a range of First in Class Sensor Cell Lines with sensor molecules that identify actin dynamics and at the same time show no interference with dynamic processes during cytoskeleton rearrangements. In detail, SenCELL LifeActTMexpress a small actin binding protein domain coupled to a fluorescent protein. This way, live cell imaging and high content analysis are now applicable to a wide variety of assays including migration assays using chemoattractants. The cell lines are functionally validated, available in bulk and shipped in frozen cell stocks. Applicable in a matter of days.

Press release in English


March 18, 2012 | Munich experts to discuss novel in vitro cell models

Munich, Germany:More than 20 scientists met in early March at IZB Martinsried near Munich to discuss ways of further improving in vitro cell models. Modern preclinical research would not anymore exist without them.

Key issues remain with regard to predictivity as there continues to be a lack of advanced cell lines resembling in vivo conditions. Instead, easy to handle cancer cell lines are often being used. Also, there are limitations with traditional 2D cell cultures.

Press release in English


February 03, 2012 |AdenoONE™ makes working with adenovirus a standard procedure

Adenovirus vector cloning and production still remain tricky with rather low yields and limited success. The brand new AdenoONE™ line of support kits turns cloning & production into an easy to schedule project step of less than 4 weeks. AdenoONE™ comprises 2 discrete kits: AdenONE™ Cloning Kit and AdenoONE™ Purification Kit. The latter allows for reliable purification within just 20 minutes. Soon will SIRION BIOTECH, also referred to as Munich’s “Cell Competence Center”, launch the AdenoONE™ Purification Kit in vivo.

Press release in English


October 24, 2011 |InSphero AG and SIRION BIOTECH GmbH announce Development & Marketing cooperation on 3D-based cell models

InSphero AG and SIRION BIOTECH GmbH, two privately-held biotech com-panies based in Zurich and Martinsried near Munich, respectively, announced today an agreement allowing for a close cooperation on the development and the promotion of most innovative cell models in the form of three-dimensional (3D) microtissues.

Press release in English


JUNE 24, 2010 | TET Systems and SIRION BIOTECH GmbH sign a commercial license agreement

TET Systems (TET) and SIRION BIOTECH GmbH, two privately-held, German biotech companies based in Heidelberg and Martinsried near Munich, respectively, announced today that they have signed a commercial license agreement. Under the terms of the agreement, SIRION BIOTECH offers customized services to its clients using the Tet Technology to generate cell lines and to generate and manufacture recombinant viral vector products.

Press release in English
Press release in German


MARCH 25, 2010 | Helmholtz Zentrum München and SIRION BIOTECH Initiate Research Cooperation to Develop New Anti-Cancer Gene Therapy Approach Using Lentiviral Vectors

Helmholtz Zentrum München has launched a new cooperative project with SIRION BIOTECH GmbH in Martinsried to develop new therapeutic approaches against lymphoid tumors. With a two-year grant from the Federal Ministry for Economics and Technology, the two partners will seek to further develop lentiviral vector systems to better understand the disease mechanisms of this cancer form and to devise approaches for treatment.

Press release in English
Press release in German


Jan 2010 | SIRION BIOTECH and Sigma-Aldrich entered into a service agreement

under which SIRION BIOTECH provides custom shRNA knockdown cell lines, utilizing validated The RNAi Consortium (TRC) shRNA RNAi libraries from Sigma Life Science. First of all the offer is limited to the German research community.


Jan 2010 | SIRION BIOTECH becomes industry partner of the FORPROTECT „Neue Genom-basierte Diagnostikverfahren und Therapieansätze zur Bekämpfung von Infektionskrankheiten“ with Dr. Christian Thirion, CSO of the company, being the speaker of this new alliance to fight infectious diseases

By identifying the antigen profiles in the natural in vivo milieu of infectious bacteria the alliance will develop new diagnostic and immunization strategies. Part of the project is also to develop more sophisticated T-Zell analysis for improved epitope maps of viral deseases.


Jan 2010 | SIRION BIOTECH successfully completes a test phase with more than 80 test sites for its new product TransMAX, an enhancer of adenovirus uptake, and launches TransMAX

The test customers detected up to 50 fold enhanced expression rates depending on the cell type. In addition, TransMAX has been shown to now enable gene transfer to human dendritic cells, mouse embryonic stem cell or skeletal muscle cells having a wide impact on the corresponding scientific areas.


Oct 2009 | SIRION BIOTECH together with Helmholtz Zentrum Munich (HGMU) receives funding from BMWi for finding new therapeutic approaches in leukemia

In the two years cooperation project funded with approx. 300 tEUR SIRION BIOTECH will facilitate viral delivery of siRNAs to hematopoietic cells which HGMU will use for target validation in leukemia research.


FEB 2007 | Contract research business for biotech and pharma started.


JUN 2006 | SIRION GmbH filed patent

SIRION GmbH filed patent for its proprietary Q-tech technology.


APR 2006 | SIRION GmbH signed license agreement with CCS GmbH

SIRION GmbH signed license agreement for storage and shipment technology with CCS GmbH, Hamburg.