Downstream Process Development
Our Downstream Process Development (DSP) workflows are designed to deliver manufacturable, high-purity biologics and peptides through a structured and scalable approach. From early-stage development to commercial readiness, we integrate Quality by Design (QbD), scale-down models, and advanced optimization strategies to ensure robustness, regulatory compliance, and seamless scalability.
Core Capabilities
Early stage Process Development
- Establish proof-of-concept purification strategies using platform technologies (e.g., Protein A affinity capture).
- Design and evaluate key unit operations, including
- Clarification (cell lysis, centrifugation, depth filtration, enzymatic treatment, refolding)
- Capture chromatography
- Polishing techniques (IEX, HIC, SEC, RP)
- Conduct smallS-scale feasibility studies for rapid process selection and screening.
QbD-Driven Process Design
- Implement a Quality by Design (QbD) framework to ensure process understanding and control.
- Perform risk assessments using Failure Mode and Effects Analysis (FMEA).
- Identify:
- Critical Quality Attributes (CQAs)
- Critical Process Parameters (CPPs)
- ApplyDesign of Experiments (DoE) to establish a robust design space.
High-Throughput Screening
- Screen chromatography resins and membrane systems using:
- Micro-scale columns
- Automated and parallel screening platforms
- Evaluate performance based on:
- Binding capacity
- Selectivity and resolution
- Resin lifetime and reusability
Scale-Down Model Development (SDM)
- Develop predictive lab-scale models that accurately represent manufacturing conditions.
- Optimize key process parameters, including:
- Chromatography cycle performance
- Viral clearance efficiency
- Mass transfer and flow dynamics
- Validate scale-down models to ensure reliable scale-up.
Process Characterization
- Conduct detailed DoE studies to define operating ranges
- Establish a regulatory-compliant design space for process flexibility
- IntegrateProcess Analytical Technology (PAT) tools for:
- Real-time monitoring of yield and purity
- Tracking impurities such as HCP, DNA, and aggregates
Process Optimization & Robustness
- Perform multi-cycle and stress testing of unit operations
- Optimize critical steps, including:
- Viral inactivation and removal
- Ultrafiltration/Diafiltration(Uf/DF) and buffer exchange.
- Demonstration process consistency, robustness and reproducibility across batches.
Late-Stage Development & Validation
- Execute Process Performance Qualification (PPQ) studies
- Prepare Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory submissions (IND, BLA)
- Support comparability studies and biosimilar development programs.
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