Scale-Up Fermentation Service

BOC Sciences provides customized scale-up fermentation services to meet our customers’ commercial production needs of target products. Based on our optimized bioreactors and proven process development, we are able to offer economically efficient and high-quality personalized scale-up service to global customers in the field of pharmaceutical, food, cosmetics, agriculture and other industries. The process validation of the pilot-scale establishes our scale-up fermentation process in order to achieve large-scale fermentation production. Our ultimate goal is to maximize production and efficiency in plant-scale production.

Introduction

The production capacity of a fermentation process is influenced by the interaction between the fermentation scale and the metabolic reactions of microbial strains. The fermentation process includes breeding microbial strains to produce compounds of interest, recovery and purification of products, and separating by-products. Scale-up is perhaps one of the most complex steps of the fermentation process, including physical (such as oxygen transfer rates and mixing time), biochemical (such as medium compositions), and process control factors (such as conditions of the inoculum). The scale-up of fermentation process strives to achieve the same productivity and quality in large-scale fermentation manufacturing as in small-scale fermentation. Biochemical engineering has a crucial role in transforming laboratory discoveries from biotechnology into large-scale manufacturing.

Scaling up fermentation usually requires process validation, utilizing new equipment or modified equipment. Scale-up fermentation refers to the conversion of a laboratory-developed process to a full manufacturing scale process. The pilot-scale fermentation with downstream support equipment is a key step to convert the laboratory-scale process into a realistic scaled-down version of the manufacturing process. Suppose the fermentation process and product of interest are highly novel. In that case, scale-up requires a second stage, demo scale, which minimizes the risk of large-scale manufacturing by further validating the process.

Overall, the key to scale-up fermentation is to achieve project goals, produce products of interest with acceptable quality and yield, as well as fully understand and control the risks of large-scale manufacturing.

Our Advantages

• We offer personalized fermentation process solutions that consider the requirements of different target products and fermentation scales.
• One-stop fermentation service from laboratory scale, pilot scale to large scale, and analysis for molecules of interest.
• Large-scale industrial fermentation tanks of different volumes from 4,000L to 12,000L, over 100,000 liters capability in total.
• EHS compliance of the comprehensive research and production chain.
• Continuous sterilization, multiple aseptic feed lines, separation and purification facility.
• GMP-certified fermentation manufacturing.
• High efficiency and competitive costs.
• Fully automated fermentation tanks capable of industrial manufacturing.

Our Methods

• Pilot process and use pilot data to design and build large-scale processes.
• Document parameters such as fermenter size, vessel geometry, stirrer size, and ungassed & gassed power input.
• Implement rigorous aseptic verification procedures throughout fermentation process.
• Install equipment & instrumentation critical to process monitoring and control.
• Perform rigorous process disturbance testing on a laboratory and pilot-scale and develop detailed disturbance response plans.
• Computational fluid dynamics (CFD) is introduced as a promising tool that can be used to support scaling up and scaling down of bioreactors
• Establishing novel sensors to measure and control insightful process parameters.
• Maintain a constant oxygen transfer rate and strict control oxygen concentration.

Project Workflow

• Customer advisory
• Project discussion
• Lab-scale and pilot-scale fermentation
• Fermentation process development
• Scale-up fermentation service
• Project delivery