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BSL BIOSERVICE

BSL BIOSERVICE Scientific Laboratories is an internationally recognised contract research organisation (CRO) and a member of an international laboratory network.

BSL BIOSERVICE – Your partner for biological safety and activity testing

BSL BIOSERVICE Scientific Laboratories GmbH is an internationally active Contract Research Organisation (CRO) and preferred partner of Eurofins, a world leader in analytical testing. The laboratories are part of a global scientific network offering services from discovery and preclinical testing to market approval.

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Experience in biological safety and activity testing

BSL BIOSERVICE has the proven experience, a wide range of services and the necessary expertise to initiate preclinical drug development by designing, performing and documenting biological safety and activity tests that meet the appropriate regulatory requirements.

A high degree of customer orientation, high quality and flexibility are core values of the company’s corporate philosophy.

A highly experienced team of scientists has designed and performed biological safety and activity programs ranging from acute through chronic toxicity and carcinogenicity studies and guarantees acceptance by national and international authorities. The specialists of BSL support customers from early research until finalisation of preclinical studies.

Testing services for different industries

Addressing markets like (Bio-)pharmaceuticals, chemicals, medical devices, agrochemicals, cosmetics and food, BSL BIOSERVICE offers a broad range of biological safety and activity testing, including:

  • Preclinical assessment
  • Pharmacology
  • Toxicology
  • Immunoanalytics
  • Bioanalytics
  • Dose formulation analytics
  • Biocompatibility
  • Microbiology
  • In vivo / in vitro bioassays

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GMP- & GLP-certified

The company’s emphasis on quality ensures that all practices are compliant to regulatory guidelines which is proven by various accreditations and certifications.

BSL BIOSERVICE has been accredited with DIN EN ISO 17025 for biocompatibility testing of medical devices and has been certified in accordance with Good Laboratory Praxis (GLP) and Good Manufacturing Praxis (GMP). The company is listed by the World Health Organisation (WHO) and has already successfully been audited by the US Food and Drug Administration (FDA).

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General information

BSL BIOSERVICE was established in 1995 and is preferred partner of Eurofins since 2008. Headquartered in Planegg near Munich, the company currently employs around 200 members of staff on approximately 3,800 square meters laboratory and office space. Around 30% of the employees have a PhD.

Contact details:
BSL BIOSERVICE

Scientific Laboratories GmbH
Behringstraße 6 / 8
82152 Planegg / Munich
Germany
Tel: +49 89 96 50-0
Fax: +49 89 96 50-11
Email: info@bioservice.com
URL: www.bioservice.com

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Bioanalytics

The Bioanalytics group of BSL BIOSERVICE serves as a high quality and professional service provider both in support of pre-clinical and clinical trials and for in vitro studies that demand specialized analytical services.

In this group of dedicated and experienced scientists a routine to working with challenging compounds and methods exists. Handling of samples is done with professionalism and in full compliance to relevant guidelines.EquipmentHPLC-MS / MS (triple quadrupole)HPLC-UVTitratorGC-MS/FIDAnalysis MethodsFormulation AnalyticsBioanalyticsMethod establishment for novel compoundsValidation in compliance with ICH Q2 (R1) and relevant EMA and FDA guidelinesComplete set…

Bioassays

For more than 25 years BSL BIOSERVICE have provided the scientific and experimental know-how to design and perform tailor-made bioassays in close collaboration with their clients.

Their development, validation and performance of bioassays / potency assays is US FDA approved and can be offered according to GLP and GMP regulations. BSL BIOSERVICE conducts the testing of about 350 batches of client material per year using a diverse range of bioassay types (in vitro and in vivo bioassays).In Vitro BioassaysAssay TypesCell proliferationCell…

Biocompatibility

Whether your need is the biocompatibility testing according to ISO 10993 or microbiological testing within development, production and finished product testing, BSL BIOSERVICE will support you with individual testing strategies and study designs to fulfill your needs. In addition, BSL BIOSERVICE offers further testing strategies for medical devices as well as for raw materials and semi-finished products.

Biocompatibility Test PanelCytotoxicitySensitizationIrritationSystemic ToxicitySubchronic ToxicityGenotoxicityPyrogenicityImplantationHaemocompatibilityChronic ToxicityMicrobiology Test PanelTest for SterilityEndotoxinsBioburdenTest for Specified Microorganisms / Microbial Limit TestTest for Antimicrobial PreservationValidation of Test MethodsIdentification of MicroorganismsTest for Antimicrobial EfficacyEvaluation of Reusables for the intended Reprocessing Procedure (Cleaning, Disinfection, Sterilization)Environmental MonitoringProcess Water TestingAnalysis of BioindicatorsSterilization ProcessesValidation of Depyrogenation ProcessesAdditional ServicesFunctional Implantation Studies (ISO 10993-6)Identification and Quantification of…

Dose Formulation Analytics

The Dose Formulation Analytics group of BSL BIOSERVICE primarily focusses on the accurate and precise quantification of test substance concentration in the application solution from toxicity studies.

Samples derive from in vivo and in vitro experiments conducted in-house whereby close collaboration between experimenter and analyst ensures the highest quality of results combined with adequate timelines.The scope of any dose formulation study entails method setup or development, validation and sample analysis. Through the extensive knowledge gained by dealing with a multitude of diverse…

Immunoanalytics

In support of preclinical and clinical trials the Immunoanalytics department of BSL BIOSERVICE contributes to biomarker analyses, pharmacokinetic studies, and the assessment of immunotoxicity and immunogenicity.

BSL BIOSERVICE provides expertise in immunoassays such as Enzyme-linked Immunosorbent Assays (ELISA), ligand binding tests, professional isolation and cryopreservation of human peripheral blood mononucleated cells (PBMC) and custom made cell-based assays.Additionally, BSL BIOSERVICE possess expert knowledge in flow cytometric (FACS) analyses such as identification and characterisation of immune cell populations in different species.The company's equipment…

In Vivo / In Vitro Bioassays

The team of BSL BIOSERVICE performs the testing of approximately 450 batches of client material per year using a diverse range of bioassay types. Batch release testing is performed for both EU and US market.

For more than 25 years BSL BIOSERVICE has provided the scientific and experimental know-how to design and execute custom bioassays in close collaboration with its global clients. BSLs expertise in establishing cellular in vitro bioassays and experience in performing non cell-based and in vivo bioassays is at your disposal in this sophisticated service.In addition to…

Microbiology

The Microbiology Department of BSL BIOSERVICE offers a comprehensive range of microbiological studies in support of facility and product monitoring of Medical Devices and (Bio-)Pharmaceuticals. Additionally BSL BIOSERVICE helps to fulfill special requirements either by standardized test designs or tailor-made studies. Long-term experience and a highly skilled team is available for the customers’ needs.

The well-equipped facility of BSL BIOSERVICE is covering all microbiological test systems for the quality control of raw materials, bulk ware, final products and stability as well as the validation of the production process. Furthermore, a broad range of studies for the product development is available.Whether your demands are small or complex - an external…

Pharmacology

BSL BIOSERVICE offers a wide range of services from early pharmacological screening studies in tissue culture, cellular assays accompanying clinical trials as well as a broad based portfolio of in vivo services.

They accelerate your candidate's development from tailor-made proof-of-concept studies, like infection and vaccination test designs under bio-safety level 2, pharmacokinetics to IND-enabling safety pharmacology. In vitro StudiesIn cooperation with leading research groups BSL BIOSERVICE have established several tests using different tissue culture models for quality control of pharmaceuticals. This offers you the opportunity to investigate a…

Quality Control

Whatever your range of demand is – in process controls or batch release testing BSL BIOSERVICE will help you as external microbiological and in vitro laboratory or as back up for a bottleneck situation – they are prepared to meet your requirements.

Toxicology

BSL BIOSERVICE performs toxicology studies and has been establishing a wide range of in vitro and in vivo study designs to evaluate the safety of substances.

In Vitro Toxicology StudiesOver the past BSL BIOSERVICE has offered a broad scope of in vitro tests resulting in a fundamental pool of historical data. Test systems are conducted under GLP compliance and meet the regulatory requirements for the safety testing of new drugs or chemicals. Furthermore, the company is well prepared to approach safety…
Quick Contact BSL BIOSERVICE
Quick Contact BSL BIOSERVICE
Quick Contact BSL BIOSERVICE


Quick Contact BSL BIOSERVICE
Quick Contact BSL BIOSERVICE
Quick Contact BSL BIOSERVICE


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