At Veranova, we offer a wide range of API separation, isolation, and processing techniques, including crystallization, filtration, drying, lyophilization, milling (wet and dry), and spray drying. Veranova can spray dry APIs and amorphous solid dispersions (ASDs), including small molecule APIs, lipids, antibody-drug conjugates (ADCs), peptides, and oligonucleotides.

Our spray-drying team collaborates closely with our in-house experts in solid form, analytical, modeling, and chemical development to offer a fully integrated approach, positioning us as the partner of choice. Veranova can support you from the feasibility of spray drying on a small scale up to our GMP kilo-scale spray dryer in our Devens facility.

Our capabilities include:

  • Büchi B-290 (0.5 g – 20 g scale)
  • ProCepT 4m8-Trix (0.5 g – 100 g scale)
  • Fluid Air PolarDry® Model 01 (GMP up to kilogram scale)

Screening and Method Development Solutions

We specialize in a comprehensive suite of techniques for API separation, isolation, and processing. Our capabilities include crystallization, filtration, drying, lyophilization, as well as both wet and dry milling, and spray drying. We excel in spray drying APIs and amorphous solid dispersions (ASDs), encompassing a range of compounds such as small molecule APIs, lipids, antibody-drug conjugates (ADCs), peptides, and oligonucleotides.

Spray Drying Scales

Veranova has the capability to spray dry APIs from small-scale (500 mg) to multiple kilo-scale in our spray drying facilities in the UK and the USA.

Solvents – Aqueous or Organic

Water can be used to spray dry some APIs, but other APIs require the use of an organic solvent. However, organic solvents require special considerations due to their flammability, toxicity, and environmental impact. Veranova can handle organic solvents using an inert loop for spray drying. The solvent content in the inert loop is managed below the lower explosion limits (LEL) using built-in sensors and system interlocks.

Spray Analysis

HELOS Sympatec-based laser diffraction is used to characterize the nozzles for your API. We have developed a machine learning (ML) model to help with nozzle selection for your product.

Sympatec QICPC (left) and Sympatec HELOS RODOS (right) to analyze, monitor and measure particle size and shape

 

Product Characterization

Veranova utilizes a full suite of material characterization technologies, including the Phenom Scanning Electron Microscopy (SEM, Phenom Pharos) equipped with a Leica K3C camera, to analyze spray-dried materials in pharmaceutical products, particularly active pharmaceutical ingredients (APIs) and amorphous solid dispersions (ASDs). SEM provides high-resolution images that reveal the surface morphology and particle size distribution of spray-dried powders. This detailed visualization helps assess critical properties like particle shape, surface texture, and porosity, ensuring optimal solubility, stability, and bioavailability of the final product. In addition to SEM, Veranova employs a comprehensive array of analytical techniques for characterizing spray-dried materials:

  • Particle Sizing (Malvern 3000)
  • Polarized Light Microscopy (Leica, Nikon)
  • Hot-stage Microscopy (Mettler Toledo)
  • X-ray Powder Diffraction (XRPD) (Empyrean) with X-ray transparent tape-covered samples
  • Thermogravimetric Analysis (TGA) using double-lidded pans
  • Differential Scanning Calorimetry (DSC) using double-lidded pans
  • Nuclear Magnetic Resonance (NMR)
  • High-Performance Liquid Chromatography (HPLC) for purity and solubility testing
  • Single Crystal X-ray Diffraction (SCXRD)

Piroxicam-Plasdone Amorphous Solid Dispersion Observed with Scanning Electron Microscopy

Piroxicam-Plasdone Amorphous Solid Dispersion Observed with Scanning Electron Microscopy

 

Spray Characterization

Veranova leverages expert know-how in spray analysis, for instance, with the advanced SprayScan mPT system, to capture detailed spray pattern characteristics, including size, shape, and distribution, enabling rapid verification of uniformity and coverage. By assessing the effects of different operating conditions, and documenting spray performance over time, the system facilitates process optimization and early detection of potential issues. This ensures Veranova’s spray-dried formulations achieve optimal solubility, stability, and bioavailability.

We use the SprayScan mPT that utilizes a laser and frame to illuminate the spray pattern for visualization

 

Controlled Substances

With 50 years of experience, Veranova specializes in supplying controlled substance APIs, including Schedule I-V compounds. We have extensive experience in manufacturing a wide range of controlled substances and opioids, ensuring reliable access to these regulated products and maintaining a secure supply. Our licenses for handling Schedule I-V compounds allow us to spray dry controlled substances at the kilo scale.

Highly Potent API Spray Drying

Veranova combines extensive technical expertise with specialized equipment to safely produce and handle highly potent APIs (HPAPIs). We utilize in-house isolators designed for effective containment practices that meet SafeBridge category 4 standards. Our isolator suites achieve an occupational exposure limit (OEL) as low as 0.01 μg/m³, and our small-scale manufacturing plants achieve a low OEL of 1 μg/m³. Our stringent adherence to low OEL levels ensures the safe and efficient production of HPAPIs, particularly for spray drying applications, leveraging our advanced technology and deep expertise.

 

Setup for HPAPI spray drying at Veranova

GMP

Veranova can manufacture spray-dried materials at the kilo scale under GMP conditions, demonstrating our capacity to meet large-scale production needs and establishing us as a reliable and trusted partner in the industry.

PolarDry® Fluid Air (left) and ProCepT Spray Dryer (right)

Model-Driven Approach

Spray drying is a complex process that requires optimization and control. It often leads to high variability in yield and particle size. We use mathematical models in gPROMS FormulatedProducts and CFD to define and optimize conditions across scales.

Time-Saving – Step Reduction Isolation from Solid from Solution

Traditional processes such as lyophilization and filter drying are usually time-intensive and variable in quality and yield. Spray drying is a promising alternative to these conventional processes, offering significant timesaving and quality improvement potential.

Oligonucleotide and Peptides

Lyophilization is a traditional method used for isolating oligonucleotides and peptides. However, it is time-intensive, requires significant space and capital expenditure (CAPEX), and can result in poor-quality products that necessitate reprocessing. Veranova’s experts in spray drying can help you evaluate spray drying as a more efficient alternative for peptides and oligonucleotides.

Amorphous Solid Dispersion

Amorphous solid dispersion is a promising solution for solubility and permeability issues in new APIs. Veranova experts can guide you through the process of selecting polymers, solvents, and equipment throughout the drug development lifecycle.

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