Biopharmaceuticals

SYNLAB Pharma is a highly qualified CRO for the pharmaceutical industry, providing a full service for all kinds of analytical tasks. Our main focus deals with biopharmaceuticals (innovator products, biosimilars, and biobetters) in pre-clinical, clinical and post-marketing studies, as well as in stability and release studies, and comparability studies. 

Our wide range of services supports our clients in the clinical development and the manufacturing process like:

  • Pharmacokinetic, Pharmacodynamic (GLP, GCP)
  • Biomarker Determination (GLP, GCP)
  • Immunogenicity (ADA, NAB), (GLP. GCP)
  • Release and Stability Testing, including storage (GMP)

The quality of our services is secured by highest standards, scientific expertise and a highly motivated team with excellent background in science, bioanalytical technologies, with regulatory competencies and excellent communicational skills.

The analyses are carried out in accordance to customer’s procedures and international pharmacopoeias (e.g. EP, USP, etc.) and recommendations from experts in the field. We deliver data of outstanding quality in requested customized formats and adhere to timelines. This is proven by long-term relationships with clients worldwide fulfilling their expectations and requirements.

Services are performed according to the relevant guidelines (e.g. ICH Q2(R)).
 

Our Services:

  • Cell based assays
  • Biochemical assays 
  • Immunological assays
  • All common read out systems and technologies
  • Transfer – Optimization – Validation
  • Storage facilities (-20°C; -75°C, 2-8°C, N2)
  • Storage under remote control
  • Storage under GMP and GLP
     
  • Qualified software tools
  • PLA 3.0
  • Customized data transfer
     
  • Reporting according to clients requests
  • Standard report formats available
  • Scientific, technical and regulatory consultation
     

For more information

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