LaborDr.Merk - Labor Dr. Merk in Ochsenhausen, Germany
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Welcome at Labor Dr. Merk & Kollegen GmbH
As a CRO and CDMO we offer comprehensive know-how for the pharmaceutical industry and for medical device manufacturers.
Whether you are looking for services in contract manufacturing, biosafety testing, vaccine retesting for the European market, testing of efficacy of disinfectants, bioassay development or a strong partner for your R&D project – we’ve got you covered! Relying on over 40 years of experience, our GMP approved facilities and our expert teams we will support you.
Besides our services in contract manufacturing, Labor Dr. Merk & Kollegen GmbH offers a wide range of testing services in the fields of virology, microbiology, immunology and toxicology.
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As a full CDMO with end-to-end process development, manufacturing with analytical characterization and regulatory support, Labor Dr. Merk & Kollegen GmbH also offers process GMP manufacturing of viral gene therapeutics, oncolytic viral therapeutics and vaccines.
Read more
Besides our services in contract manufacturing, Labor Dr. Merk & Kollegen GmbH offers a wide range of testing services in the fields of virology, microbiology, immunology and toxicology.
Read more
As a full CDMO with end-to-end process development, manufacturing with analytical characterization and regulatory support, Labor Dr. Merk & Kollegen GmbH also offers process GMP manufacturing of viral gene therapeutics, oncolytic viral therapeutics and vaccines.
Read more
As a CRO and CDMO with more than 40 years of relevant experience, Labor Dr. Merk & Kollegen GmbH is a strong partner for your R&D projects.
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Since 1971, Labor Dr. Merk & Kollegen GmbH has evolved into a diversified testing laboratory and CDMO. We provide process development and GMP manufacturing of viral gene therapeutics, oncolytic viral therapeutics and vaccines, as well as testing services in virology, microbiology, immunology.
Read more
As a CRO and CDMO with more than 40 years of relevant experience, Labor Dr. Merk & Kollegen GmbH is a strong partner for your R&D projects.
Read more
Since 1971, Labor Dr. Merk & Kollegen GmbH has evolved into a diversified testing laboratory and CDMO. We provide process development and GMP manufacturing of viral gene therapeutics, oncolytic viral therapeutics and vaccines, as well as testing services in virology, microbiology, immunology.
Read more
Do you enjoy working in small project teams with flat hierarchies? We are always looking for motivated people to join our team!
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Do you have a question or want to work with us? Then please don’t hesitate to contact us via phone, email or using the form below. We will be in touch as soon as possible!
Read more
Do you enjoy working in small project teams with flat hierarchies? We are always looking for motivated people to join our team!
Read more
Do you have a question or want to work with us? Then please don’t hesitate to contact us via phone, email or using the form below. We will be in touch as soon as possible!
Read more
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"Since many years Labor Dr. Merk & Kollegen GmbH and Institut Virion\Serion GmbH enjoy a trustful collaboration to provide to its customers high-quality reagents for Complement Fixation Tests. The collaboration is designed with the aim to combine Labor Dr. Merk`s expertise in manufacturing erythrocytes and Institut Virion\Serion`s experience in manufacturing high grade serological antigens. Working with Labor Dr. Merk was always professional, friendly and goal-oriented."
Head of International Sales
February 2016
Frederic Paquet
"The Labor Dr. Merk & Kollegen GmbH performed several studies for virucidal efficacy of disinfectants according to European Standards and German guidelines of the DVV (German Association for the Control of Virus Diseases). With their excellent expertise all our studies were successfully completed with great reliability within the timelines. Service, reporting and communication was outstanding."
February 2016
Dr. Jörg Götz
"At Labor Dr. Merk & Kollegen I supervised the virus validation of a monoclonal antibody as a consultant. The virological and technical support by Labor Dr. Merk & Kollegen was impressive and contributed significantly to the success of the study. Furthermore, the Quality Assurance under GLP and the ample available space were outstanding. Considering the broad spectrum of established Class 2 test virus systems I can strongly recommend the Virus Validation Facility at Labor Dr. Merk & Kollegen in Ochsenhausen for further studies."
2014
Herbert Dichtelmüller, Ph. D.
"The laboratory of Dr. Merk & Kollegen GmbH tested the virucidal activity of some of our disinfectants according to the European Standard EN 14476. Due to their experience, the results were absolutely reliable and demonstrated that the method was controlled. Communication, documentation and reporting were of high Quality."
2014
Peter Goroncy-Bermes
Pressemitteilung englisch
In August 2019 LMK successfully passed an inspection by the competent authority Regierungspräsidium Tübingen which ended now in the permission to manufacture an oncolytic virus with immune-stimulatory cargo. So LMK holds now a Manufacturing Authorization for a Drug Substance in the context of ATMPs („Advanced Therapy Medicinal Products“) according to the German Drug Law § 15 Abs. 3a S.1 Nr.6.
In September 2018 LMK successfully passed an extensive inspection by the FDA. We owe this success to our highly competent and professional staff. The authority’s expectations were met in full, after assessing LMK’s laboratory facilities and quality assurance system against strict cGMP standards. In the closing meeting the FDA inspector emphasized his appreciation for LMK’s comprehensive and coherent data as well as for our well established procedures to secure data integrity.
Labor Dr. Merk & Kollegen GmbH holds long lasting excellent expertise in biosafety testing of products from pharmaceutical industries or medical device manufacturers. Especially in the fields of virological and microbiological testing as well as cell based bioassays a wide range of GMP and GLP compliant methods for preclinical and clinical studies or quality control of final products are available.
The company is expanding their business by offering R&D services for process development and GMP manufacturing of oncolytic viruses, viral vaccines and viral vectors. This expansion is supported by the European Regional Development Fund (ERDF).
Manufacturing Authorization
In August 2019 LMK successfully passed an inspection by the competent authority Regierungspräsidium Tübingen which ended now in the permission to manufacture an oncolytic virus with immune-stimulatory cargo. So LMK holds now a Manufacturing Authorization for a Drug Substance in the context of ATMPs („Advanced Therapy Medicinal Products“) according to the German Drug Law § 15 Abs. 3a S.1 Nr.6.
In September 2018 LMK successfully passed an extensive inspection by the FDA. We owe this success to our highly competent and professional staff. The authority’s expectations were met in full, after assessing LMK’s laboratory facilities and quality assurance system against strict cGMP standards. In the closing meeting the FDA inspector emphasized his appreciation for LMK’s comprehensive and coherent data as well as for our well established procedures to secure data integrity.
Labor Dr. Merk & Kollegen GmbH holds long lasting excellent expertise in biosafety testing of products from pharmaceutical industries or medical device manufacturers. Especially in the fields of virological and microbiological testing as well as cell based bioassays a wide range of GMP and GLP compliant methods for preclinical and clinical studies or quality control of final products are available.
The company is expanding their business by offering R&D services for process development and GMP manufacturing of oncolytic viruses, viral vaccines and viral vectors. This expansion is supported by the European Regional Development Fund (ERDF).
