Biologics Testing Services

Biologics Testing Services - Sartorius Croatia

Development, qualification, and validation are essential for creating and launching a high-quality product. In collaboration with our partner Sartorius, we provide our clients with fully integrated biological development services - from cell line development to commercial production, carried out in Sartorius' state-of-the-art laboratories in this part of Europe. A comprehensive, fully compliant portfolio of biosafety tests helps to generate the data needed to establish specifications and support the efficient release of product.

Reliable Partner for Biological Testing

When producing biological products from mammalian cell lines and viruses, there is an inherent risk of introducing microbial- and viral-based contaminants. Compliance with regulatory pharmacopeia guidelines is demonstrated through biological testing, so it is important to choose a reliable partner with methodical solutions, analytical testing, and biotherapeutic characterization. Following global pharmacy standards, Sartorius conducts biological testing in FDA, MHRA, and EMA-accredited facilities for testing biological drugs, gene therapies, viral vectors, cell therapies, viral vaccines, new biological drugs, and biosimilars. Sartorius' comprehensive portfolio of test methods enables:

  • in-depth characterization studies of biologically active substances
  • rapid decision-making and test planning tailored to the appropriate regulatory guidelines based on the development stage
  • GMP, GLP and GDP regulation compliance
  • testing for clinical batch release or fully validated tests required during clinical phase III and final regulatory submission

Cell Line Characterization

Sartorius, with over 200 biosafety tests, has extensive experience in characterizing cell banks used in the production of biologic drugs for protein- and virus-based therapies. QC testing plans meet the requirements for the release of mammalian cell banks and are designed to comply with ICH Q5A regulations with tests validated according to GMP standards.

cGMP Cell Bank Manufacturing and Characterization

Product characterization

Successful approval of biological drugs depends on robust product characterization — an analytical data package that defines the characteristics and structure of the biotherapeutics and demonstrates safety, efficacy, purity, quality, and potency. Ensure successful approval of biological drugs with a comprehensive product characterization solution.

Protein Characterization and Biosafety Testing Services

Lot release testing

Collecting appropriate data and submitting documentation to relevant regulatory authorities is one of the biggest challenges when launching a product on the market. The safety profile assessment is conducted through thorough testing aimed at detecting any contaminants in the production process. Once contamination has been ruled out, further processing to generate the drug substance and final drug product can continue. Release testing at these final stages is a regulatory requirement for all marketed products to confirm the identity, purity and potency of the drug substance and final drug product.

Support for Your Program, From Preclinical to Commercial Phase

Sartorius' unique set of integrated services enables the outsourcing of your biological development program from cell line development to commercial batch release. With the early-stage characterization test package, all future GMP qualification and validation needs are anticipated, while preparation for future analytical development eliminates costly delays in later stages. Combined with a comprehensive, fully compliant portfolio of biosafety tests, Sartorius helps generate the data needed to establish specifications and support the efficient release of products to the market.

Speed & Capacity

  • save time and resources with pre-validated cGMP analyses and QC testing plans that shorten the time required to obtain results
  • enable additional internal analytical capacities for development and focus on the developmental goals of processes and drugs
  • rely on a partner fully compliant with cGMP and with excellent audits from the FDA, EMA i MHRA

Expertise & support

  • enabled access to Sartorius's extended team of experts — technical and regulatory teams
  • experience and knowledge of regulatory requirements for market release in Europe, the USA, Japan, and South Korea
  • Sartorius is a partner for Bulk Harvest Testing, which is primarily tested for biosafety parameters that prove the absence of viral and microbial contaminants, genetic stability, and the identity of cell banks, as well as the issuance of the final product batch