Successful IND Submission and Market Authorization Rely on Robust Protein Characterization for Every Stage of Development
Biologics manufacturers must have an in-depth understanding of their therapeutic protein in terms of structure, physicochemical properties, and biological activity. With an increasing number of complex therapeutics based on multiple mechanisms of action, the identification and characterization of proteins have become equally complex. Identifying and linking the attributes of a protein to clinical performance are required through development, but those essential characterization activities also serve as the basis for program acceleration, reducing risk of delays down the line.
Sartorius’ protein characterization services are scaled to each phase of drug development. These services include development, qualification and validation of product characterization assays, such as cell-based potency assays, binding assays and physicochemical tests. Our panel of assays have been pre-qualified with commercial monoclonal antibodies and can shorten analytical development timelines.
The range of analytical testing services Sartorius offers is backed by a team of scientists with years of technical and regulatory experience.
Data-rich Orthogonal Techniques to Meet ICH Q6B Guidelines
Sartorius offers a comprehensive range of protein characterization methods, including carbohydrate profile, post-translational modifications, and impurities. Our ready-to-use assays utilize state-of-the-art techniques to ensure the ICH Q6B scientific guidelines are met, resulting in an efficient, streamlined development process.
Our orthogonal methods for key physicochemical properties include:
- Intact and reduced mass, size exclusion chromatography, and capillary electrophoresis SDS to assess molecular weight and size
- Ion exchange chromatography, capillary isoelectric focusing, and reverse-phase LC/MS profiling for assessing isoform patterns
- Capillary electrophoresis SDS and capillary isoelectric focusing for electrophoretic patterns
- Size exclusion chromatography and ion exchange chromatography for liquid chromatographic patterns
Advance Protein Characterization with High-resolution Analyses
Protein-based therapeutics have an inherent degree of structural heterogeneity. Characterizing this is an essential requirement for the development process and a critical part of the IND submission. Post-translational modifications can affect in vivo stability, resulting in loss of biological activity and cause unwanted immune effects.
Sartorius offers methods to characterize and confirm protein sequence and identity, carbohydrate profile, and post-translational modifications.
Our state-of-the-art methods can cover the following ICH Q6B requirements:
- Glycan analysis offers a range of methods tailored to your stage from CLD integrated Labchip and UHPLC methods to high resolution LC/MS for in-depth characterization
- Amino acid sequence, peptide mapping, and post-translational modifications – peptide mapping with single or multi-enzyme digest for up to 100% coverage, along with intact mass for preliminary protein identity
- Sulfhydryl group(s) and disulfide bridges – non reduced peptide mapping
Detailed Insights into Your Protein Products Biological Interactions
Detailed Insights into Your Protein Products BiCharacterization is a critical part of the development of protein-based therapeutics. Our mix of ready-to-use and customizable binding assays contribute to the comprehensive characterization of your product. Sartorius applies a range of cutting-edge technologies to ensure each platform suits your needs, including surface plasmon resonance (SPR), enzyme-linked immunoassays (ELISA), electrochemiluminescence (ECL), and mesoscale discovery (MSD). We also offer a full range of ready-to-use Fc characterization assays to assess the potential of your biologic to elicit an immune response.
Our range of ready-to-use and platform binding assays include:
- Fc Binding Characterization
- Binding kinetics
- ELISA binding assays
- Cell based binding assays
De-risk Analytical Development with Sartorius Cell Based Assay Expertise
Sartorius offers ready-to-use and customizable cell based assays, allowing you to save time while still fully characterizing your molecule’s biological activity and potency. Our platforms measure your molecule’s effector functions, induction or inhibition of secondary and tertiary activities (including immune interactions such as ADCC, ADCP, and CDC), and antibody internalization. With full GMP capabilities, Sartorius is positioned to take your assay from development to validation and lot release.
Our expertise covers:
- Custom potency assays – development, phase 1 GMP qualification, and phase 3 GMP validation
- Immune cell assays
- Cell based binding assays
- Fc functional characterization assays – Total PBMC ADCC, lymphoid enriched ADCC, NK cell ADCC, reporter ADCC, ADCP, reporter ADCP, and CDC
Ready-to-use and Platform Assay Solutions for Immuno-oncology
Checkpoint inhibitor drugs require extensive characterization, including assays that help elucidate the mode of action on immune cells. Our new immuno-oncology assay toolbox brings together ready-to-use assays with platform methodologies to fast-track assay development and protein characterization.
- 50% reduction in assay development time
- IgG1 and IgG4 pre-developed assays
- Standalone characterization package or integrate with our CHO platform services from CLD to cell banking
- Link physicochemical and structural analyses with binding and functional assays to fully understand your molecule and speed up development
- Platform complex functional assays, including T cell exhaustion, ADCC/ADCP, Fab arm switching, and potency assays ready to optimize for your molecule
Immuno-Oncology In Vitro AssaysPDF | 451.9 KB
Development and Qualification of a Complex Potency ELISAPDF | 1.5 MB
Proven Experience and a Comprehensive View
Since 2007, our experienced team has established a range of platform methodologies available for quick development of critical bioassays. During clinical phases, a qualified potency bioassay is generally required for lot release, while at commercial phase, this assay must be fully validated. Leveraging a functional bioassay alongside structural and physicochemical analyses at early phases of development allows developers to make key decisions early on, minimizing delays in costly clinical phases.
Because characterization runs concurrently throughout clinical and commercial phases, it’s possible to inform decisions on pool and clone level, analyze critical quality attributes and get a head start on complex bioassay development needs. Plus, our protein characterization forms an integral part of our platform of services for protein-based therapeutics. This includes cell line development featuring the high-performing Cellca cell line and optimized media, as well as fully compliant cell banking and cell bank characterization services to ensure a seamless progression from DNA to MCB.
Webinar – Critical Steps for Protein Potency Assay Development
Learn from a Sartorius expert the process of assay development, qualification, and validation for potency assays and how Sartorius supports customers through this vital step.
How a Single Provider Can Reduce Protein Biologic Development Risk
In this webinar, Sartorius and Sonnet BioTherapeutics discuss the benefits of the Sartorius CHO Platform of integrated products and services.