Controlled lyophilization nucleation system for drug development
Achieve consistent freeze-drying outcomes with precise nucleation control, enhancing product uniformity and stability while streamlining drug development processes.
Controls Nucleation in Freeze-Drying Processes
The ControLyo® Nucleation Technology from SP is a leading-edge solution in the realm of lyophilization systems. It uniquely manages the nucleation phase of freeze-drying, allowing pharmaceutical and biologics manufacturers to specify nucleation at precise times and temperatures. This controlled process transforms traditionally passive freeze-drying into an efficient, consistent operation, enhancing product uniformity and optimizing drying times. Commonly applied in the production of vaccines, monoclonal antibodies, and lyophilized powders, ControLyo® excels in supporting both R&D and large-scale manufacturing with seamless scalability. Its integration into existing freeze dryers eliminates the need for additional equipment, conforming to Quality by Design (QbD) standards without requiring formulation changes. The system’s energy efficiency contributes to reduced primary drying durations, translating to lower operational costs and enhanced throughput. Crafted from durable materials suitable for harsh processing conditions, ControLyo® ensures long-term reliability while adhering to pharmaceutical industry regulations.
Benefits
- Ensures consistent product quality by controlling nucleation, reducing variability in lyophilization.
- Accelerates production cycles with 3% reduction in primary drying time per 1˚C increase in nucleation temperature.
- Enhances protein formulation stability by minimizing stress-induced protein aggregation.
- Facilitates straightforward scale-up across different freeze dryers, improving operational efficiency.
- Incorporates seamlessly into existing systems, avoiding costly equipment upgrades and maintaining QbD compliance.
- Applications
- Liquid formulations,Pharmaceutical powder,Biopharmaceuticals,Drug development,Protein formulations
- End products
- Injector pen solutions,Vaccines,Insulin,Monoclonal antibodies,Lyophilized biologics,Liquid medications,Lyophilized powders,Protein therapeutics
- Steps before
- Drug Development,Formulation,Heterogeneous ice nucleation
- Steps after
- Primary drying,Scale-up,Quality inspection,Product uniformity verification
- Input ingredients
- biologics,protein formulations,vials,lyophilization process inputs
- Output ingredients
- lyophilized products,enhanced product uniformity,improved cake appearance
- Market info
- SP Scientific is known for manufacturing high-quality freeze dryers, laboratory thermal control systems, and aseptic processing equipment, catering primarily to the pharmaceutical, biotech, and life sciences sectors with reputation for precision engineering and reliable performance.
- Nucleation Temperature Increase
- 3% reduction in drying time per 1 ˚C increase
- Freezing Consistency
- Uniform nucleation across all vials
- Protein Stability
- Reduced protein aggregations
- Compatibility
- Retrofits into most existing commercial freeze dryers
- Automation
- Control of nucleation process
- Process Input Control
- Enables Quality by Design (QbD)
- Equipment Requirement
- No additional freeze-drying equipment needed
- Working Mechanism
- Controlled Nucleation
- Integrated Steps
- Freeze-drying
- Batch vs. Continuous Operation
- Batch
- Temperature Control
- Customizable nucleation temperature
- Reproducibility
- High across different freeze dryers
- Compact footprint
- Yes
- Control panel type
- Integrated
- Uniform freezing
- All vials
- Retrofit compatibility
- Most existing dryers
- Retrofit compatibility
- Integrates into most existing commercial dryers