Downstream Process Optimization
BOC Sciences offers downstream process (DSP) optimization services for microbial fermentation. We can extract, concentrate, and purify products from fermentation broths with our comprehensive facilities and advanced technologies. BOC Sciences preserved over 20 years of experience in microbial fermentation, we expertized in target products and impurities separation as well as separation of molecules with different particle sizes economically. Our quality control concept runs through the complete fermentation process to provide our customers with high-quality and purity products.
The downstream process (DSP) refers to separating and refining the product of interest from the reaction broth, culture broth, or fermentation broth during the mass cultivation of microbial fermentation strains. The DSP involves multi-step procedures for the recovery and purification of target products, which is also the most costly process in the pharmaceutical industry. Therefore, optimization of microbial fermentation DSP is critical. DSP optimization involves a variety of techniques such as chromatography, membrane technology, crystallization, and distillation. For example, proteins expressed by microbial strains can be recovered and purified using size-exclusion chromatography or membrane separation techniques. As a result, the goal of DSP optimization is to achieve low cost, efficient yield, and high purity production of the target product through the most straightforward process, as well as easy disposal of process waste.
Application of DSP Optimization
Pharmaceutical relevant agents productions include small molecules and biomolecules, such as antibodies, enzymes, hormones, growth factors and recombinant protein vaccines. The development and optimization of fermentation DSP expand the production of these valuable molecules, particularly, fulfill the requirements stated by authorities, including the Food and Drug Administration. In biological drugs manufacturing, product quality highly depends on the production process. Therefore, optimization and establishment of generic fermentation DSP can be served as a practical approach to achieve large-scale production under safe and compliant conditions.
- Personalized downstream process solutions based on different target products’ requirements and fermentation scales
- Advanced processing and production facilities, including fermenters of different sizes, continuous sterilization, multiple aseptic feed lines, separation and purification equipment.
- High efficiency and competitive costs.
- Experienced in microbial fermentation from laboratory scale to large-scale production.
- Equipped with fully automated fermenters and capable of industrial manufacturing.
- Effective separation and purification technologies.
- Comprehensive capability to perform complex molecules extraction and production.
Technologies for product separation and purification from fermentation broth, including but not limited to:
- The solid-liquid separation technologies, including centrifugation, filtration separation, sedimentation separation, etc.
- Cell breaking technologies, including high temperatures, ultrasound, osmotic pressure, surfactant and wall lysing enzymes, etc.
- Membrane separation technologies, including microfiltration (MF), ultrafiltration (UF), reverse osmosis (RO), dialysis, electrodialysis (ED), gas separation (GS), permeate vaporization (PV), emulsion membrane (ELM).
- Protein purification technology, such as precipitation, chromatographic separation and ultrafiltration, etc.
- Product packaging, such as vacuum drying and freeze-drying, etc.
Concepts of Quality by Design (QbD) provides complete guidance for the fermentation process to maximize the product's efficacy and safety.
- Customer advisory
- Project discussion
- Downstream process optimization
- Target molecules extraction and purification
- Scale-up fermentation and large-scale fermentation
- Project delivery