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Ensuring consistent quality across batches of pharmaceutical products is challenging. Variations in raw materials, equipment performance, or human error can impact product quality. The risk of contamination during production can lead to recalls, regulatory sanctions, and financial losses. Maintaining stringent cleanliness and contamination control measures is crucial.
Dependence on specific raw materials, including Active Pharmaceutical Ingredients (APIs) and excipients, can lead to supply chain disruptions. Shortages or price fluctuations can impact production schedules and costs. Transporting pharmaceutical products, particularly those requiring special storage conditions (e.g., temperature-sensitive biologics), involves complex logistics and can be prone to disruptions.
Pharmaceutical manufacturing generates waste, including hazardous materials. Companies must manage waste effectively and comply with environmental regulations to minimize their impact. There is growing pressure to adopt sustainable manufacturing practices, reduce energy consumption, and minimize environmental impact. This can require significant investment and changes to existing processes.
