How can you use process control to improve biopharmaceutical quality?

3 Process control methods

Process control methods can be classified into two categories: feedback and feedforward. Feedback control uses the information from the output of the bioprocess or bioreactor to adjust the input or the operating conditions. For example, if the temperature of the bioreactor is too high, a feedback controller can lower the heating rate or increase the cooling rate. Feedforward control uses the information from the input or the disturbances of the bioprocess or bioreactor to adjust the output or the operating conditions. For example, if the concentration of a nutrient in the feed stream is too low, a feedforward controller can increase the dosage or flow rate.

4 Process control techniques

Process control techniques can be divided into two groups: conventional and advanced. Conventional techniques use simple mathematical models and rules to design and implement the controllers, such as proportional-integral-derivative (PID) controllers, which are widely used in industrial applications. Advanced techniques use more sophisticated mathematical models and algorithms to design and implement the controllers, such as model predictive control (MPC), which can optimize the performance and robustness of the bioprocesses and bioreactors.

5 Process control challenges

Process control faces several challenges in biopharmaceutical applications, such as nonlinearity, complexity, variability, and uncertainty. Nonlinearity means that the bioprocesses and bioreactors do not behave in a simple or predictable way, and may exhibit multiple steady states, oscillations, or bifurcations. Complexity means that the bioprocesses and bioreactors involve many interrelated components and interactions, and may require multiple inputs and outputs, multiple controllers, and multiple objectives. Variability means that the bioprocesses and bioreactors are affected by random or stochastic factors, such as noise, disturbances, or measurement errors. Uncertainty means that the bioprocesses and bioreactors are not fully known or understood, and may require estimation, identification, or adaptation.

6 Process control benefits

Process control can provide many benefits for biopharmaceutical applications, such as improved quality, reduced waste, increased efficiency, enhanced safety, and lower environmental impact. Improved quality means that the bioprocesses and bioreactors can produce biopharmaceuticals that meet the specifications and standards of purity, potency, and activity. Reduced waste means that the bioprocesses and bioreactors can minimize the generation of by-products, impurities, or contaminants. Increased efficiency means that the bioprocesses and bioreactors can optimize the use of resources, such as energy, materials, or time. Enhanced safety means that the bioprocesses and bioreactors can prevent or mitigate the risks of accidents, failures, or infections. Lower environmental impact means that the bioprocesses and bioreactors can reduce the emissions of pollutants, greenhouse gases, or hazardous substances.