Spray Drying Process Screening and Scale-Up
Spray Drying Process Screening and Scale-Up
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Spray Drying Process Screening and Scale-Up

Biopharmaceutical Drying

Accelerate your biopharmaceutical drying pipeline from lab-scale feasibility through pilot optimization to industrial production.

  • Comprehensive excipient pre‑formulation and compatibility screening
  • Lab‑scale feasibility testing with active client participation
  • Pilot‑scale optimization with ≈ 5–6 L/h evaporative capacity
  • Microencapsulation and controlled‑release particle engineering
  • Seamless scale‑up support to production‑grade equipment

Why Choose Our Spray Drying Service?

Accelerate your spray drying development from lab to production with our dedicated equipment and hands‑on process development expertise. Our stepwise approach ensures that each decision is data‑backed and reproducible, reducing risk as you move from pre‑formulation to industrialization. We provide state‑of‑the‑art lab‑ and pilot‑scale spray dryers equipped with bag‑filter collection for high yield, and deliver detailed reports with process parameters and quality recommendations. Real‑time decision‑making during processing days allows you to actively guide the development of your formulation.

  • End‑to‑end development path from pre‑formulation to industrialization
  • State‑of‑the‑art lab‑ and pilot‑scale spray dryers with bag‑filter collection
  • Real‑time decision‑making during your processing days
  • Detailed reports with process parameters and quality recommendations
Integrated
Scalable
Qualified
Our Methodology

A Stepwise Spray Drying Development Path

We combine systematic formulation screening, process parameter optimization, and analytical characterization to deliver robust, scalable spray‑dried products.

Formulation and Process Development

We evaluate excipient compatibility, conduct lab‑scale feasibility tests, and optimize atomization and drying parameters to achieve target particle properties.

  • Excipient pre‑formulation and compatibility studies
  • Lab‑scale testing (L/h evaporation capacity)
  • Process parameter optimization with two‑fluid or rotary nozzle

Scale‑Up and Technology Transfer

Successful lab‑scale formulations are transferred to pilot‑scale equipment (≈ 5–6 L/h) to simulate production conditions and refine parameters before full‑scale industrialization.

  • Pilot‑scale runs on food‑grade, bag‑filter equipped dryer
  • Thermodynamic and atomization scaling rules
  • Production‑grade equipment support (≈ 8 kg/h evaporative capacity)

Quality Management

Each batch is characterized for particle size, morphology, crystalline state, residual solvent, and stability to meet project‑specific acceptance criteria.

Process Optimization

We apply design‑of‑experiments and model‑based methodologies to systematically map the effect of inlet temperature, feed rate, and atomization pressure on product attributes.

Analytical Characterization

Comprehensive solid‑state analysis (XRD, DSC, SEM, particle size distribution) supports informed decisions on formulation and process robustness.

What You Receive

Comprehensive Deliverables Across the Development Continuum

From feasibility reports to scaled batches, every project delivers actionable data and physical samples tailored to your program goals.

Development Deliverables

  • Spray‑dried powder batches from lab and pilot runs
  • Process parameter documentation (temperature, feed rate, atomization pressure)
  • Particle size distribution and morphology data
  • Residual solvent and moisture content analysis

Reporting and Support

  • Detailed study report with experimental design and results
  • Recommendations for formulation and process optimization
  • Scale‑up risk assessment and industrialization roadmap
  • Ongoing consultation for technology transfer (subject to project scope)
Service Scope

Parameter‑Driven Development Tailored to Your Molecule

Each project is scoped individually based on your drug substance properties, target product profile, and development stage. The table below outlines typical capabilities.

ParameterTypical Project Scope
Excipient screeningUp to 10 excipients in compatibility panels; results guide formulation selection
Lab‑scale evaporative capacityL/h (water); suitable for gram‑scale sample production
Pilot‑scale evaporative capacity≈ 5–6 L/h (water); produces kilogram‑scale quantities for application testing
Atomization optionsTwo‑fluid nozzle or rotary atomizer; selected per viscosity and target particle size
Drying gasHot air or nitrogen; closed‑loop inert option for solvent‑based feeds
Particle collectionBag filter (standard) or cyclone; yields > performance scoped per project
Process optimizationDesign‑of‑experiments (DOE) on inlet temperature, feed rate, atomization gas flow
Analytical suiteXRD, DSC, SEM, laser diffraction particle sizing, Karl Fischer moisture
Scale‑up supportThermodynamic scaling rules are used to transfer process parameters across scales, and a dedicated production‑grade unit with 8 kg/h evaporative capacity is available for scale‑up runs.
Regulatory complianceSuitable for non‑clinical development
How It Works

Five‑Stage Spray Drying Development Workflow

We follow a structured, iterative path from formulation through industrialization, ensuring each decision is data‑backed and reproducible.

Feed Solution Preparation

Your active ingredient is dissolved or suspended with selected excipients (polymers, surfactants, stabilizers) in a suitable solvent system to create a homogeneous feed.

Atomization and Drying

The feed is atomized into fine droplets via a two‑fluid or rotary nozzle inside a chamber with controlled hot gas flow. Solvent evaporates rapidly, forming dry particles.

Particle Collection

Dried particles are separated from the exhaust gas using a bag filter or cyclone. The collection system ensures high yield and protects product from contamination.

Process Optimization

Key parameters – inlet temperature, feed rate, atomization pressure, gas flow – are systematically varied to tune particle size, morphology, and amorphous content.

Scale‑Up and Verification

Optimal lab parameters are transferred to pilot‑scale, then to production‑scale equipment. Batches are tested for consistency, and a scale‑up report is delivered.

Applications

Where Spray Drying Adds Value in Biopharmaceutical Development

Our service supports a broad range of drug delivery strategies and stabilization challenges across pharmaceutical, nutraceutical, and cosmetic industries.

Enhance Solubility and Bioavailability

Spray drying is a leading technology for manufacturing amorphous solid dispersions (ASDs), converting poorly soluble crystalline drugs into a high‑energy amorphous state within a polymer matrix.

  • Improves dissolution rate and oral bioavailability
  • Enables continuous manufacturing with process analytical technology

Protect Sensitive Ingredients and Control Release

Multiple microencapsulation techniques tailored to your active – from taste masking to extended release – can be integrated into the spray drying workflow.

  • Encapsulates probiotics, enzymes, and volatile oils
  • Provides moisture and oxygen barrier for stability

Engineered Particles for Pulmonary Delivery

Spray drying generates particles with controlled aerodynamic diameter (1–5 µm), ideal for dry powder inhaler (DPI) products targeting deep lung deposition.

  • Tunable particle morphology (spherical, porous, corrugated)
  • Compatible with carrier‑free and carrier‑based DPI systems

Improve Long‑Term Stability Without Freezing

Low‑temperature spray drying with stabilizing excipients can produce stable dry powders of proteins, replicon‑NLC vaccines, and other biologics, extending shelf life.

  • Eliminates the cold chain for logistics flexibility
  • Demonstrated for nucleic acid vaccines and lipid nanoparticle complexes
Frequently Asked Questions

Objections and Clarifications About Spray Drying Services

Answers to common questions regarding feasibility, equipment, scale‑up, and regulatory suitability.

  • We process solutions, suspensions, and emulsions of small molecules, biologics, probiotics, and nucleic acids dissolved or dispersed in water or volatile organic solvents. The feed must be pumpable and stable under process conditions. A preliminary compatibility test is recommended for novel formulations.

  • Typical lab‑scale runs require a few grams of active ingredient per condition, depending on the evaporative capacity and target particle size. Exact minimum quantities are confirmed during the scoping phase to ensure meaningful results with your available material.

  • Yes, our pilot‑scale spray dryer can be operated in closed‑loop mode with nitrogen as the drying gas. This is recommended for oxygen‑sensitive APIs or when using flammable organic solvents. The bag filter collection system maintains containment.

  • We apply thermodynamic scaling rules (constant drying potential / constant atomization energy) to maintain product quality attributes across lab, pilot, and production scales. Key parameters such as droplet size and drying temperature profile are validated by sampling at each stage.

  • Yes, we provide a complete analytical package including X‑ray diffraction, differential scanning calorimetry, scanning electron microscopy, particle size distribution, residual solvent analysis, and moisture content. Additional assays can be included per project scope.

  • Low‑temperature spray drying is available with controlled inlet temperatures down to ambient levels. We also use glass‑forming excipients that protect the active during drying and storage. Compatibility and stability are evaluated in the pre‑formulation phase.

  • We provide a comprehensive scale‑up report including process parameters, performance data, and risk assessment to facilitate technology transfer. The specific support level is defined in the project SOW.

Scientific Literature

References

  1. Baumann JM, Adam MS, Wood JD. Engineering Advances in Spray Drying for Pharmaceuticals. Annual review of chemical and biomolecular engineering. 2021;12:217-240. View on PubMed
  2. Qiao F, Wang S, Xuan S, et al. Nontargeted Lipidomics Reveals Key Membrane Lipids in Three Bifidobacterium animalis Strains with Different Spray Drying Resistance. Journal of agricultural and food chemistry. 2025;73(24):15443-15458. View on PubMed
  3. Hibbard T, Shankland K, Al-Obaidi H. Preparation and formulation of progesterone para-aminobenzoic acid co-crystals with improved dissolution and stability. European journal of pharmaceutics and biopharmaceutics: official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V. 2024;196:114202. View on PubMed
  4. Block M, Sieger P, Truenkle C, et al. Miniaturized screening and performance prediction of tailored subcutaneous extended-release formulations for preclinical in vivo studies. European journal of pharmaceutical sciences: official journal of the European Federation for Pharmaceutical Sciences. 2024;196:106733. View on PubMed
  5. Qu J, Jia C, Chen Y, et al. Design and Optimization of Indomethacin Nanocrystals using Machine Learning and Molecular Dynamics Simulations. AAPS PharmSciTech. 2026;27(3). View on PubMed
  6. McClary WD, Chen JZ, Wang H, et al. A spray dried replicon vaccine platform for pandemic response. International journal of pharmaceutics. 2025;680:125777. View on PubMed

Please kindly note that our products and services are for research use only.