Commercialising product development in the pharmaceutical industry is a complex task. After years of research, companies need to make sure that their products are effective, cause minimal side effects and are environmentally friendly in order to be commercially viable. The drive to reduce risks associated with pharmaceutical treatments, coupled with minimising its carbon footprint are huge challenges.
A silent partner, The Linde Group is a leading supplier of gases and applications to the pharmaceutical industry. It has succeeded in developing solutions that meet the evolving needs of the pharmaceutical industry in a variety of applications across the production chain . from R&D to quality control. Linde’s suite of applications targets the manufacturer’s needs, from gas solutions for several applications to improving the controllability of the lyophilisation process to yield enhancement through cold processing knowledge and to state-of-the-art technology that meets strict environmental regulations.
A key challenge in scaling up pilot processes is minimising the side reactions that generate unwanted compounds that can form in a commercial operation, but are not seen in the labscale process. In these cases, product yield can be significantly improved by cooling the reaction to a very low temperature.
Uniform ice nucleation during lyophilisation
Lyophilisation is an important example of a downstream process and is critical for stabilising valuable compounds. The high value of lyophilised drugs, as well as FDA initiatives such as Quality by Design and PAT, demand improved process control to achieve good product quality.
Control of the product nucleation temperature is a critical issue in lyophilisation and can adversely affect the product’s uniformity because it can lead to less-than-optimal freeze-drying cycles. Linde has developed a novel technology through a collaboration with a leading freeze-drying OEM to address this ice nucleation step during the lyophilisation process and it is applicable to laboratory, pilot and production-scale freeze dryers.
Yield growth through cold temperature processing
A key challenge in scaling up pilot processes is minimising side reactions that generate unwanted compounds, which can form in a commercial operation, but are not seen in the lab-scale process. In these cases, product yield can be significantly improved by cooling the reaction to a very low temperature.
As drugs become increasingly complex, the demand for synthesis and crystallisation at very low temperatures also grows. Low temperature cooling of process fluids is both necessary and beneficial to achieve a high degree of process control and stability that will increase product quality, yield and selectivity. Linde’s CUMULUSR Fluid Temperature Control system is the optimal solution for rapidly bringing the process down to very low temperatures. It uses liquid nitrogen as a cooling medium to automatically cool process fluids in a highly controlled manner.
Reduce volatile organic compound emissions
Concerns about greenhouse gases also place pressure on pharmaceutical manufacturers to minimise volatile organic compounds (VOCs) as these can create health and environmental hazards. Linde’s CIRRUSR vapour emission control systems are a comprehensive approach to minimising the release of VOC.
The nitrogen-based cryogenic process is chlorofluorocarbonfree that does not generate wastewater. Furthermore, there is no secondary pollution in the form of nitrogen oxides, acids, gases and dioxins. The inert nitrogen does not come into direct contact with the VOC, which means that the condensed VOC and evaporated nitrogen can be recycled and reused for other purposes in a customer’s process, thus significantly reducing operating costs and increasing sustainability.
Cost-effective and adaptable solutions
Customer needs and environmental regulations are constantly changing, which means that pharmaceutical companies require partners that are swift and can adapt to the industry’s evolving needs. Linde’s solutions are a proven portfolio of cost-effective solutions, targeted to meet these demands.