Pharma QC Solutions Designed to Meet GxP Requirements
Sartorius specializes in delivering innovative QC instruments and consumables for microbiological, physicochemical, and biological analyses, supporting accurate and reliable results.
With a focus on efficiency and compliance, Sartorius empowers laboratories worldwide to streamline their Quality Control (QC) processes and maintain the highest standards in product safety and potency.
Our portfolio includes products:
Pharmaceutical Microbiology Quality Control
In a pharma QC microbiology laboratory, the primary objective is to identify viable microorganisms at every stage of the production process: in the air, raw materials, water and finished products. This enables lot release with the assurance of safety, efficacy and purity. To achieve this, regulatory compliant equipment and consumables are required and help to promote safe handling while minimizing the risk of false positives and false negatives.
Sartorius supports your contamination control strategy (CCS) with consumables and hardware for:
Biologics Analytical Quality Control
All drug products have to be QC tested using robust methods that are appropriately qualified and validated under GxP conditions.
Since biologics are more complex than small molecule drugs, analytical systems designed with simple workflow steps such as the Octet® instrument allow QC labs to implement straightforward methods which greatly simplify the testing process.
Sartorius offers a comprehensive GxP package that includes tools such as IQOQ, PQ and software validation support that make Octet® instruments ideal for regulated quality control (QC) labs. QC labs typically use the Octet® BLI platform for lot release assays and for in-process testing for ligand binding, concentration and impurity (host cell proteins (HCP) and residual protein A (RPA)) detection. Octet® instruments are routinely used for amongst others, potency analysis of drug-target and drug-Fc receptor(s) (FcyRI, FcyRIIa, FcRIII and FcRn) interactions and to develop stability indicating methods that assess changes in activity through stressed and forced degradation assays. The high-throughput capability and flexibility of the Octet® RH16 and RH96 systems allow for design of experiments (DOE) that enables rapid development of robust assay methods for assessing critical quality attributes (CQAs).
Sample Preparation Essentials for QC
Sample preparation is a critical step in Quality Control (QC) laboratories, particularly in GxP-regulated environments, where the accuracy and reliability of analytical results are non-negotiable. The process of preparing samples directly impacts the ability to detect and quantify analytes accurately, making it essential for laboratories to employ tools that ensure consistency and precision.
The QC lab is responsible for ensuring that products are free from contaminants that could harm patients or compromise the quality of the final product. This necessitates the use of sample preparation tools that can detect contaminants at the lowest possible levels while ensuring the highest level of reproducibility.
Main Regulations for QA/QC Labs
Regulations are changing quickly to improve patient, consumer, and environmental protection. QC and QA managers need to stay informed about these changes and understand their impact on laboratory equipment, even with busy schedules and administrative tasks.
Sartorius breaks down the key regulations affecting QA/QC labs and provides easy-to-follow guidance for adapting to and implementing these changes.
Lab Connectivity & Data Integrity
Modern laboratories face challenges with inefficiencies in data management and compliance. Manual processes often lead to errors and delays, putting data integrity at risk. Ensuring GxP compliance and data security, while overcoming productivity bottlenecks and decision-making obstacles, is essential to improving lab efficiency and accuracy.
Enhance your lab's efficiency and accuracy with Sartorius' comprehensive lab software solutions. Our digitalization tools enable paperless workflows and seamless connectivity across your lab.
Tailored for QC Lab Managers and Lab Automation Specialists, these solutions deliver reliable test results, validated data systems, and robust data integrity. With built-in compliance for GxP regulations, our software safeguards against unauthorized access and data manipulation, ensuring accuracy and consistency.
Boost productivity, streamline data handling, and make confident decisions with Sartorius' advanced lab solutions.
Biologics Testing
A Comprehensive Biologics Testing Service Supports Drug Developers and Commercial Biologics Manufacturers From Discovery Through Commercial Manufacturing
When producing biologic products from mammalian cell lines and viruses, there is an inherent risk of introducing microbial- and viral-based contaminants. Regulatory bodies such as the European Medicines Agency (EMA), Medicine and Healthcare Products Regulatory Agency (MHRA) and Food & Drug Administration (FDA) ensure the safety and test of new protein-based biologics, biosimilars, viral vector gene therapy and viral vaccines. These guidelines are determined by the nature of the cell line or virus and the intended use of the product – and compliance is demonstrated through biologics testing.
Sartorius provides comprehensive biologics testing solutions for all stages of drug development, from discovery to commercial release.
Our global cGMP-compliant testing facilities are FDA- and MHRA-approved for biologics testing of viral vector gene therapies, cell therapies, viral vaccines, new biologics and biosimilars.
Outsourcing biologics testing to Sartorius expedites analytical development and lot release timelines with immediate access to highly specialized ready-to-use or custom assays, platform methods and complex analytical equipment – ultimately expanding your quality control workbench.
