The scaling up of pharmaceutical manufacturing is a significant milestone in the drug development timeline. Employing a seamless process to ramp up production as your company moves to human clinical trials and eventual commercialization is essential to ensure your patients' safety and maximize the potential commercial success of your drug. There are many new and unpredictable challenges which are sure to arise while increasing production of a drug substance or product, making it critical to carefully plan and execute each step in the process to avoid problems which can jeopardize the quality or safety of the drug.
As your drug substance or product moves from its discovery and formulation stages into human clinical trials, its manufacturing process must be able to produce consistent, high-quality batches of the drug which meet strict quality standards set by regulatory agencies such as the FDA. As you aim for greater production efficiency and lower costs, consider partnering with a CDMO experienced in successfully scaling up manufacturing to gain invaluable assistance in planning and executing the process.