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Biologics Analytical Quality Control

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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).

When the Highest Level of Regulatory Compliance is Required

Laboratories involved in pharmaceutical drug development and manufacturing must meet GxP (GLP/GCP/GMP) regulations. Computer controlled analytical systems used in GxP applications must be validated and properly maintained. With the optional Octet® GxP Package, several instruments including Octet® R8, RH16 and RH96 can be operated in compliance under current GxP regulations. The comprehensive package has been specifically designed with a high level of in-built GLP/GCP/GMP:

  • Installation and Operational Qualification (IQ/OQ) Kit and Services
  • Performance Qualification (PQ) Kits
  • Octet® 21 CFR Part 11 Software
  • Software Validation Package Support
  • Biosensor Validation Service
Validated Software with 21 CFR Part 11 Technical Controls

Protecting the security and integrity of electronic records (ER) is essential for compliance. This includes ensuring the reliability and trustworthiness of ER used to support critical decisions.

Features in Octet® GxP Software include:

  • Details on Octet® CFR Software features for implementation of FDA 21 CFR Part 11-compliance requirements
  • Instructions for installation qualification of the Sartorius FB Server Monitor software and Octet® CFR Software
  • Detailed operational qualification sections with:
    • Instructions and templates for testing routine calculations and important curve fits
    • Test files for result confirmation in .xlsx (Excel), .pzm (Graph Pad Prism), .efrd (Octet® analysis settings) and frd files (Octet® data)
Benefits of Fluidics-Free Biolayer Interferometry

Using the label-free optical technique of Bio-Layer Interferometry (BLI), the Octet® platform provides real time analysis of biomolecular interactions. It relies on a robust and easy to use fluidics-free format thereby minimizing the complexity in analyte detection compared to fluidics-based technologies like SPR. It provides high-throughput analysis, with the option of analyzing up to 96 samples in parallel. The BLI technology has high tolerance to different sample types, lending itself compatible with in-process testing during drug substance manufacturing. In addition, the samples analyzed on an Octet® system can be reused for other analysis, minimizing depletion of precious samples and maximizing process economy. All Octet® systems are easy to use and in combination with the high-throughput capability allow for enhanced productivity of up to 40X and 16X over ELISA and the majority of SPR instruments, respectively.

Biologics Analytical Quality Control Features
Titer and Protein Quantitation graph

Titer and Protein Quantitation

Traditional protein concentration determination techniques such as HPLC and ELISA are being supplanted by more robust Octet® BLI assays in both upstream and downstream bioprocesses. Accurate and fast assays that measure protein concentration and that can be used to determine potency are easy to develop on the Octet® platform and can be transferred hassle-free to QC and manufacturing.

  • Analyze a full plate (96-samples) of IgG titer in as little as two minutes
  • Assay directly in crude and unpurified samples
  • Optional automation for walkaway high throughput analysis

Read Application Note

protein contaminant diagram

Impurity Testing

Quickly detect and monitor potential process induced impurities such as host cell proteins (HCPs) and protein A residues with better precision and robustness than traditional ELISAs.

Sartorius provides ready to use Octet® kits for the detection of residual protein A and CHO based HCPs.

The Residual Protein A kit is designed to detect recombinant protein A constructs and MabSelect SuRe™ (Cytiva) down to 100 pg/ml.

The Anti-CHO HCP detection kit using Anti-CHO antibodies (Cygnus Technologies) can detect as low as 0.5 ng/ml of HCPs with precision of 5 - 10% CVs.

Fc Receptor Binding Assays diagram

Fc Receptor Binding Assays

Antibodies are often engineered to achieve desired properties that include binding to FcγRs. The safety and efficacy of a therapeutic monoclonal antibody can be greatly impacted by its binding to both the target and to the FcγR.

Octet® systems offer high throughput and sensitive methods for Fc receptor binding analysis, with a variety of biosensor surfaces available for rapid and flexible assay development.

Read Application Note

Ligand Binding Potency Assays diagram

Ligand Binding Potency Assays

Reproducible ligand binding assays can be used to develop methods for the accurate evaluation of drug potency. The methods can in turn be used to assess manufacturing lot-to-lot variability by monitoring either the drug binding response or the binding kinetics and the affinity of the biomolecular interaction.  

The Octet® platform:

  • Readily accommodates the use of different designs of experiments (DOEs) to rapidly develop robust potency measurement methods
  • Provide relative affinity constant or response signals for potency measurements and comparability studies

Read Application Note


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