Manufacturability Assessment
Early evaluation of biologic candidates is essential for minimizing development risks and accelerating successful commercialization. Protheragen offers manufacturability assessment services that encompass in-depth characterization of molecular properties, stability profiles, expression potential, and process-related behavior, aiming to support data-driven candidate selection and optimize downstream development strategies.
Overview of Manufacturability Assessment
Selecting the optimal biologic candidate requires more than evaluating biological activity. Molecule properties such as structural stability, aggregation tendency, expression performance, and purification behavior can significantly impact downstream development, manufacturing scalability, and product quality.
Our Manufacturability Assessment platform enables early-stage evaluation of biologic candidates through comprehensive analytical characterization and developability studies, helping clients identify potential risks and select candidates with improved manufacturing potential.
By integrating molecular analysis, stability evaluation, and process compatibility assessment, we support informed decision-making before advancing into cell line development, process optimization, and clinical manufacturing.
Fig.1 The development process for antibody therapeutics is being improved by early assessment of antibody developability using emerging high-throughput experimental and computational methods. (Makowski, E. K., et al., 2021)
Our Services
A multi-dimensional evaluation framework covering post-translational modifications, physicochemical properties, and molecular stability - providing a complete picture of candidate developability.
Post-Translational Modification (PTM) Assessment
Post-translational modifications can significantly influence the safety, efficacy, stability, and manufacturability of therapeutic proteins. Early identification of PTM liabilities supports rational candidate selection and molecular optimization.
Services include
- Identification of potential PTM hotspots through comprehensive sequence analysis
- Experimental confirmation using advanced mass spectrometry technologies
- Assessment of common PTMs, including:
Deamidation
Isomerization
Oxidation
Glycosylation
Other critical modification sites
- Evaluation of the impact of PTMs on product quality and manufacturability
Physicochemical Characterization
A thorough understanding of molecular properties provides essential information for downstream process development and quality control.
Evaluate recombinant protein expression levels using transient transfection systems to estimate production feasibility.
Analyze protein integrity and common molecular modifications using mass spectrometry.
- Molecular Size Heterogeneity
Characterize aggregation, fragmentation, and size variants using: SEC-HPLC, CE-SDS
Assess charge heterogeneity and isoelectric point using: Cation Exchange Chromatography (CEX), Imaged Capillary Isoelectric Focusing (iCIEF)
Evaluate protein conformational stability using Differential Scanning Fluorimetry (DSF).
Molecular Stability Assessment
Stress studies are performed to evaluate molecular robustness under conditions commonly encountered during manufacturing, storage, and transportation.
Stability Studies Include:
- Accelerated thermal stability (40°C)
- Photostability
- Agitation (shaking) stability
- pH stability under acidic and alkaline conditions
- Oxidative stability
- Freeze–thaw stability
These studies help identify degradation pathways and support formulation and process development.
Workflow
Why Choose Us
- Early Risk Identification
Detect molecular liabilities before significant development resources are invested.
- Comprehensive Experimental Characterization
Evaluate critical quality attributes using advanced analytical technologies.
- Data-Driven Candidate Selection
Support objective selection of lead candidates with improved manufacturability.
- Reduced Development Risk
Minimize downstream challenges in cell line development, process optimization, and manufacturing.
- Seamless Transition to CMC Development
Assessment results directly support subsequent Cell Line Development, Process Development, and Analytical Development activities.
A comprehensive manufacturability assessment provides the critical insights needed to make informed development decisions at the earliest stage. By identifying potential molecular liabilities and evaluating key developability attributes, Protheragen helps you select candidates with the greatest potential for successful manufacturing and commercialization. The assessment results also provide a strong scientific foundation for subsequent cell line development, process optimization, analytical development, and large-scale manufacturing. Contact us to evaluate manufacturability early, reduce development risks, and build a strong foundation for successful biologics manufacturing.
Reference
- Makowski, E. K., et al. "Discovery-stage identification of drug-like antibodies using emerging experimental and computational methods" mAbs, 2021, 13(1).
