Service Overview

• Bioanalytical capabilities to support the analysis of both large and
   small molecules

• Bioanalytical method development and validation following the most recent
   international guidelines

• Bioanalytical method adaption and cross-validation of existing methods

• Bioanalytical services for toxicology studies under full GLP compliance

• Bioanalytical support for all types of Phase I studies
   (FIM, PK, PD, Interaction etc.)

• Bioanalytical services to support large Phase II-IV multicenter studies 
   (>50000 samples; >3 years duration)

• Biomarkers

• Highly flexible transfer of bioanalytical data in different formats

• Customized reports (eCTD) to meet individual sponsor needs

 

YOUR BENEFIT

• Over 30 years of experience in Bioanalytics

• Well trained and highly motivated staff with an average of
   > 15 years of practical experience

• GLP certified since 1994

• Frequent inspections by clients and excellent regulatory standing with
   a variety of regulatory agencies, including EU, U.S.A. and Brazil.

• High flexibility for smaller sponsors and big pharma

• One face to the sponsor (personnel continuity)

• Low employee turnover (<3%)

 

METHOD DEVELOPMENT,
VALIDATION AND SAMPLE ANALYSIS

• Greater than 500 non proprietary methods developed and validated in
   a large variety of matrices (plasma, urine, feces, saliva, bile,
   semen, cerebrospinal fluid (CSF), and a variety of solid tissues)
   Validated Assay List

• Validation criteria follow FDA (May 2001), Workshop/Conference report
   of Crystal City (February 2007) and EMA 2011 guidelines

• Special expertise in steroid hormone analysis (LC/MSMS, GC/MS)

• Development, validation, and utilization of dried blood spot assays

• Experience in the development and validation of peptide assays
   via LC/MS/MS

• Special expertise in trace element analysis by ICP-MS, pioneer in
   elemental analysis as a CRO service: 15 years of quantitative
   analysis e.g. iodine, platinum, lithium

• Extensive experience in the analysis of organic nitrates (GC/MS)

• Special expertise in prostaglandin analyses (LC/MS/MS)

• In-depth experience in the analysis of biphosphonates (LC/MS/MS)

• Substantial bioanalytical expertise to support
   Biopharmaceutical Development (ELISA, RIA, Flowcytometry)

• Biomarkers

• Method Transfer, Adaptation, and Revalidation

• Cross Validation

• Protein-Binding

• Routine analysis of light-sensitive, unstable, or endogenous analytes

• Numerous assays with lower limits of quantification (LLOQ) between
   1.0 and 10.0 pg/mL

• Flexible organization of instruments and staff to include the capability
   to process large sample batches in a short time.

• > 250 000 samples analysed per year

• Approximately 300-400 projects per year from early toxicology phase
   and clinical phase I - IV studies

• A comprehensive sample logistics service with a dedicated logistics 
   manager is available to ensure the safe transit of frozen samples from
    investigator sites

 

QUALITY STANDARDS

• GLP certified since 1994 (German regulatory authorities)

• GCP – Good Clinical Practice

• Detailed internal audit program 

• License for handling narcotics

• ANVISA (Brazil) Inspected and Approved

• FDA (frequent BIMO inspections)

• Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit 
   (GLP, Local Agency)

• ZAB, Regierung von Oberbayern (GCP, local Agency)

• QM Service for Clients / Customers

• 100% internal QC check

• EMA reflection paper

 

FACILITY

• One of the largest bioanalytical single site laboratories in Europe

• 2500 m² lab space arranged over several floors, state of the art facility

• Temperature monitoring using Rees-system 24 hours a day and
   7 days a week

• Large capacity for storage at 5°C, -20°C and -70°C

• Validated CFR Part 11 compliant oracle-based Laboratory Data 
   Management System

Contact

Business Development
Please send us an Email!



Exhibitions

CURIOUS 2018
Future Insight Conference
16.07. - 18.07.2018
Darmstadt / Germany


CPhI Korea
Mix the world of Pharma products, People & solutions
28.08. - 30.08.2018
Seoul / South Korea


BioFit
7th edition
Fostering Innovation & Transfer
04.12. - 05.12.2018
Lille / France