Pharmaceuticals

SYNLAB Pharma has a long-term expertise not only for compendial testing of small molecule drugs and biologics under GMP conditions, but also for special analytical tasks, e.g. method development, potency assays, impurity characterization and biomarker analyses. The combination of those preclinical capabilities together with SYNLAB´s clinical trial support offers a broad variety of services to our customers from early drug development beyond market approval.  

SYNLAB Pharma holds certifications for GMP, GLP, GCP and GLCP to cover the whole range from batch release to clinical trial support.   
 

Our Services:

  • Compendial (USP, EP) & non-compendial testing
  • EU batch release
  • Physico-chemical testing of small molecule drugs (NCEs) and biologics (NBEs)
  • Stability storage and testing
  • Cleaning validation
  • Elemental analysis
  • Particle testing
  • Spectroscopic testing (IR, UV, NMR)
  • Regulatory support
  • Check of identity, content, purity, and robustness
  • Customized method development for NCEs and NBEs
  • Validation in accordance with ICH Q2(R1) or based on client demands and equipment (assay and identification)
  • Accuracy, precision, specificity, LOD/LOQ, linearity and range
  • Limit test and quantification
  • Validation protocol and report
  • Method transfer
  • Testing of Drug Substances, Drug Products and Excipients
  • In use stability testing
  • Method development, -validation and -verification
  • Sterility and bacterial endotoxin testing
  • Microbiological contamination testing and identification of microorganisms
  • Microbial assays of antibiotics
  • Environmental monitoring
  • Extractables studies, simulation studies, toxicological evaluation, leachables studies
  • Studies are carried out in our GMP laboratory according to the most recent guidelines
  • Stress tests and compatibility studies of packaging materials are included
     
  • Analysis of genotoxic and highly potent substances, narcotic agents and chemotherapeutic agents
  • Analysis of substances with unknown biological and toxicological effects
  • Analysis of contaminants in Drug Substances / Drug Products and degradation products during stability studies
  • Preparative isolation of contaminants
  • Risk analysis and toxicological assessment (PDE-Data)
  • Elemental impurities screening (ICHQ3D)
  • Synthesis of non-compendial reference standards, including complete characterization
  • Preparative isolation of impurities with complete characterization
  • Storage, packaging and shipping of reference standards
  • Submission of a Certificate of Analysis (GMP) for reference standards
  • Storage of stability and stress samples under controlled ICH-conditions
  • Analysis of samples using state-of-the-art equipment according to the established stability protocol
  • Quantification of biopharmaceuticals
  • Bioassays for release and stability testing (potency assay)
  • Quantification of drugs and metabolites in various matrices
  • Immunogenicity strategy (ADA, neutralising assays)
  • Analysis of biomarkers
  • Developing and implementation of strategies for the analysis of innovative products, biosimilars and biobetters
  • Toxicokinetic and PK analysis
  • Analytical support in DDI and BE / BA studies
     
  • Analytical services for phase I - IV
  • Real-time safety analysis (phase I)
  • Routine lab testing
  • PK/PD incl. method development and validation
  • Biomarkers: Identification and assay development
  • Various matrices including serum, plasma, urine, stool, CSF, sputum, tissue, etc.
  • Immunogenicity strategy: ADA, NAB, including characterization
  • Support of multi-national or global clinical trials
  • Visit-specific kits and study-specific lab manuals
  • Transportation logistics for ambient, cooled and frozen samples
  • Customised project and data management

For more information

contact us