Trade press release

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

May 29, 2024

Sterile filter arrangement for process gas inlet. (Photo: GEA)

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.

Sterilization using pure steam is the preferred and proven method within the pharmaceutical industry. For complex designs and where the product is in contact with the equipment surface, air pockets must be removed by applying vacuum. These demanding requirements are met by the new generation of GEA ASEPTICSD® Spray Dryers (patents pending). (Graphic: GEA)

Sterilization using pure steam is the preferred and proven method within the pharmaceutical industry. For complex designs and where the product is in contact with the equipment surface, air pockets must be removed by applying vacuum. These demanding requirements are met by the new generation of GEA ASEPTICSD® Spray Dryers (patents pending). (Graphic: GEA)

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.

Dr. Michael Golek

CONTACT

Phone: +49 211 9136 1505

About GEA

GEA is one of the world’s largest suppliers of systems and components to the food, beverage and pharmaceutical industries. The international technology group, founded in 1881, focuses on machinery and plants, as well as advanced process technology, components and comprehensive services.

With more than 18,000 employees, the group generated revenues of about EUR 5.4 billion in more than 150 countries in the 2023 fiscal year. GEA plants, processes, components and services enhance the efficiency and sustainability of customer’s production. They contribute significantly to the reduction of CO2 emissions, plastic usage and food waste. In doing so, GEA makes a key contribution toward a sustainable future, in line with the company’s purpose: ”Engineering for a better world“. GEA is listed on the German MDAX the European STOXX® Europe 600 Index and is among the companies comprising the DAX 50 ESG, MSCI Global Sustainability as well as Dow Jones Sustainability World and Dow Jones Sustainability Europe Indices.
 
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