GEA presents pharmaceutical GEA ASEPTICSD® spray dryer at ACHEMA 2024 in Frankfurt

GEA continues to expand its portfolio of pharmaceutical spray dryers. At ACHEMA in Frankfurt (June 10-14, 2024, Hall 4.0, Stand G66), GEA will present the new GEA ASEPTICSD® spray dryers. They are specially designed for pharmaceutical spray drying applications. From antibiotics, vaccines, hormones and allergens to monoclonal antibodies, therapeutic peptides and proteins, blood products and powders for parenteral infusions, the spray dryers offer versatile solutions. The spray dryers can also be designed to handle organic solvents, allowing the use of a variety of carriers within the formulation. The new models are based on many decades of spray drying expertise and over 10,000 GEA spray dryers supplied and designed worldwide, as well as testing for customers in the high five-figure range.

GEA standards have set the benchmark for spray drying in the pharmaceutical industry.

Aseptic spray drying can convert a sterile solution into sterile particles of the desired size in a single step, without the risk of introducing impurities. Over the past three decades, spray drying has become the preferred technology for producing powder formulations with defined critical quality characteristics. Small molecule active ingredients are combined with excipients, typically in organic solvents, and spray dried. The resulting spray-dried dispersions (SDD) usually exhibit improved bioavailability compared to conventional powder formulations. GEA’s previous spray dryer models, the Pharma Spray Dryer (PHARMASD®) and GEA standards, have set the benchmark for spray drying in the pharmaceutical industry.

GEA ASEPTICSD® spray dryer as a consistent development of the pharmaceutical GEA standard spray dryer PHARMASD®.

The new GEA ASEPTICSD® aseptic spray dryers have the same functions, the same sizes and capacities, the same design and the same chamber geometry as the standard GEA PHARMASD® pharmaceutical spray dryers. This allows an efficient process transfer from non-sterile to sterile spray drying and optimizes time and costs. However, the new GEA ASEPTICSD® spray dryers are equipped with an advanced cleaning system, steam sterilization functions, multiple sterile filters and filter integrity testing before and after aseptic processing. Process data obtained during the preclinical research and development (R&D) phase can be used to successfully develop a robust, regulatory compliant process to produce sterile powders for clinical trials and commercial production.

Trials at the Drying Test Center in Denmark to develop customized solutions

At the Drying Test Center in Denmark, GEA's pharmaceutical spray drying specialists work with customers to develop the optimum system for their processes and products. All details are taken into account, including the customer's existing equipment and budget. GEA offers comprehensive spray drying support, from single drop drying kinetic studies to evaluate possible formulations, feasibility testing and scale-up. The process design can then be transferred from the technical pilot plant to the GEA ASEPTICSD®
spray dryer.

Background information:

What are the advantages of spray drying compared to freeze drying?

While freeze drying (lyophilization) is traditionally used to dry large molecules (often biologics) in aqueous solutions, spray drying offers numerous advantages:

• Lower capital investment
• Lower operating costs (less energy consumption)
• Minimal system footprint
• Continuous process with rapid drying times
• Simplified scale-up
• Particle technology to control the physical properties of the powder (particle size, shape, density)
• Powder with increased surface area and dissolution rate
• Non-frozen state, stable powder without salts or cryoprotectants
• Evaporation of organic solvents and easy solvent recovery in larger aseptic spray dryers

Can heat sensitive biologics be spray dried?

Many interested parties ask GEA if heat sensitive biologics can be spray dried? Yes, this is possible. During spray drying, the product is briefly exposed to hot gas temperatures of over 100 °C, but evaporative cooling ensures that the product remains below this temperature range - typically 60 °C to 80 °C, sometimes lower, especially for non-aqueous feeds. This brief exposure of a few seconds ensures product integrity and activity retention. In several cases, spray-dried products have shown higher activity than freeze-dried products, due to less exposure to phase changes during freezing and shorter residence times in spray dryers.