Production & preservation of drugs
Patient safety is critical to the pharmaceutical and biotech industry. The business is often complex and manufacturing of medicines is governed by rigorous regulations. Traceability and careful quality and process control are therefore required for the gases used in products.
Our solutions for the production and preservation of drugs
API (Active Pharmaceutical Ingredients) manufacturing
Air Liquide offers gas solutions for the manufacture of active pharmaceutical ingredients, API (Active Pharmaceutical Ingredients). The gases are produced and delivered according to GMP (Good Manufacturing Practice), GDP (Good Distribution Practice) and the specifications in the European Pharmacopoeia. We supply a range of different gas applications, e.g. for cell cultures, inerting, temperature control, pelletisation and particle size reduction.
Biomanufacturing - Cell culture
Upstream bioprocessing applications require a mixture of oxygen (O2), nitrogen (N2), and carbon dioxide (CO2). This mixture is sparged through the cell culture media to provide replenishment of oxygen during cell growth.
In addition, carbon dioxide is used for pH control, while nitrogen is used to strip excess carbon dioxide out of solution and balance the overall flow rate.
With Air Liquide, you can be confident in the reliability and quality of the gas supply for your controlled atmospheres.
Cryogenic pelletizing
Many scientific studies highlight the role of the gut microbiome in human health and the potential benefits of probiotics. Efficient pelletizing of live microbial strains, such as probiotics, often requires very low temperatures. Air Liquide provides cryogenic solutions and tailored equipment to meet your needs.
Inerting, protective atmosphere and purification
Raw materials, API and excipients can be sensitive to oxygen and moisture in the air. Therefore, they must often be protected with an inert gas to avoid unwelcome reactions, so that the active properties of the drug can be preserved. Inertization, protection and purification with nitrogen also contribute to reducing the risk of ignition and explosion when, for example, storing flammable solvents and milling powder. Air Liquide's solutions, which include gas, equipment and services, give you optimized nitrogen consumption and precise control.
Reduction of particle size
Reducing the particle size of the API and excipients plays an important role in the properties and quality of the final product, i.e. solubility, uniform content and stability. Air Liquide offers a cryo-milling application where the material is cooled to low or very low temperatures with a cryogenic liquid, usually liquid nitrogen, so that the particles have a dense size distribution.
Process temperature control
Certain steps in the manufacture of API, such as chemical reactions at low temperatures, require low or very low temperatures. Liquid nitrogen can be used to cool the process, either directly or indirectly as it is vaporized and heated.
Freeze drying is often the process of choice for stabilizing therapeutic proteins or vaccines. Cryogenic freezing is an environmentally friendly alternative to conventional refrigerants (CFCs) in freeze drying, as the production cycle can be reduced.
Pharmaceutical formulation, packaging and distribution
Air Liquide offers solutions that can help you protect sensitive products from exposure to oxygen, optimize the composition of the drug and maintain a cold chain for your clinical and biological samples. In collaboration with you, we design the gas installation and ensure that you get the gas supply that best suits your requirements and needs.
Logistics for the cold chain
Temperature variations can affect the stability of a medicine and thus its healing effect. Temperature-sensitive pharmaceutical and diagnostic products must be kept stable during distribution and arrive at their final destination without damage.
Air Liquide offers solutions that include cold chain logistics with dry ice or liquid nitrogen. Even very sensitive deliveries of e.g. clinical samples, vaccines, diagnostic and biological equipment can be stored and transported without damage.
Packaging
Some medicines are sensitive to oxygen and moisture in the air. Therefore, they often have to be protected with an inert gas in order for them to maintain their healing effect. Some therapeutic proteins are packaged in a nitrogen atmosphere during fill-finish operations to extend shelf life.
As the gas comes into direct contact with the final pharmaceutical product, it is important that the gas supply is reliable and complies with current regulations.
Analysis and quality control
Analysis and quality control are performed on raw materials and final products to detect traces of impurities or to determine quantities of various components.
Air Liquide supplies a number of analytical gases commonly used for laboratory and analytical instruments. We offer ALPHAGAZ™ pure gases used as carrier gases.
