Fermentation CDMO Service
Fermentation is a biological process in which microorganisms (such as bacteria, yeast, and molds) metabolize organic substances under suitable conditions to convert them into specific products. It plays an indispensable role in various aspects of our lives, from traditional applications such as brewing, bread-making, and yogurt production to modern high-tech industries such as biopharmaceuticals, bioenergy, and biomaterials. Fermentation serves as a magical link between nature and human needs. In the vast field of biotechnology, fermentation technology is crucial and provides core support to industries such as pharmaceuticals, food, and chemicals.
As a leading fermentation CDMO service provider, BOC Sciences has comprehensive technology platforms in bioprocessing and microbial fermentation. With GMP complied quality system and over 20 years of experience in microbial pharmaceutical development, we provide contract fermentation services to world-wide partners in big pharma, biotech and biopharma company, offering solutions for the development and biomanufacturing of a broad range of biological molecules and product types such cytotoxic and sterile products.
Applications of Fermentation Technology
1. Food Industry
Traditional Fermented Food Production
Alcoholic Beverages : This includes wine, beer, and spirits. Yeast is the key microorganism in winemaking, converting the sugars in grape juice into alcohol and carbon dioxide while producing various flavor compounds. For example, in Champagne production, specific yeast strains contribute to its signature bubbles and complex fruity and floral aromas.
Soy Sauce and Vinegar : The production of soy sauce involves the fermentation of soybeans and wheat by Aspergillus molds, which break down proteins into amino acids and starches into sugars. These are then further fermented to develop soy sauce's unique umami taste and color. Vinegar fermentation is primarily driven by Acetobacter, which oxidizes alcohol into acetic acid. Different raw materials and fermentation processes result in distinct types of vinegar, such as rice vinegar and aged vinegar.
Yogurt and Cheese : Yogurt is produced through the fermentation of milk by lactic acid bacteria, which break down lactose into lactic acid, lowering the pH of milk and causing proteins to coagulate, creating yogurt's thick texture and tart taste. Cheese production also relies on lactic acid bacteria, along with enzymes like rennet. Some cheeses undergo fermentation for months or even years, resulting in a wide range of flavors and textures.
Food Additive Production
Amino Acids : Amino acids produced through fermentation, such as glutamic acid and lysine, are important food additives. Glutamic acid is the main component of monosodium glutamate (MSG), which enhances food's umami flavor. The fermentation process typically involves specific bacteria, such as Corynebacterium, under optimized conditions for large-scale amino acid synthesis.
Organic Acids : Organic acids like citric acid and lactic acid can be obtained through fermentation. Citric acid is widely used in the food industry as an acidulant and antioxidant, helping to regulate acidity, improve flavor, and extend shelf life. Lactic acid is used in yogurt production and in meat processing to adjust pH levels and inhibit harmful microbial growth.
2. Pharmaceutical Industry
Many antibiotics are produced through microbial fermentation. For example, penicillin is derived from Penicillium fermentation. Strict control of fermentation conditions-such as temperature, pH, and dissolved oxygen levels-is essential for high yields. After fermentation, complex extraction and purification processes are required to obtain pharmaceutical-grade penicillin.
Similarly, a significant portion of cephalosporin antibiotics is produced via fermentation. These antibiotics play a critical role in treating bacterial infections and are a cornerstone of modern medicine.
Vitamin Production
Vitamins such as B vitamins and vitamin C can be produced using fermentation. For instance, vitamin B₂ (riboflavin) is obtained through bacterial fermentation. Fermentation-based vitamin production is cost-effective and environmentally friendly, meeting large-scale pharmaceutical and nutritional supplement demands.
Vaccine Production
The production of some live attenuated and inactivated vaccines involves fermentation technology. For example, in influenza vaccine production, viruses are propagated in embryonated eggs or cell culture systems, which can be considered a specialized form of fermentation. Optimizing fermentation conditions can enhance viral yields, ensuring sufficient antigen components for large-scale vaccine production.
3. Chemical Industry
Bioplastic Production
Fermentation can be used to produce bioplastics such as polyhydroxyalkanoates (PHA). These biodegradable plastics are synthesized by microorganisms during fermentation using carbon sources like glucose or fats. After fermentation, the microbial cells are processed to extract PHA, which can be used to manufacture packaging materials, disposable tableware, and other biodegradable plastic products. This helps mitigate environmental pollution caused by traditional plastics.
Organic Solvent Production
Fermentation can also produce organic solvents such as acetone and butanol. Certain Clostridium species can ferment sugars or cellulose-based raw materials into these solvents. Fermentation-derived organic solvents have widespread applications in industries such as coatings, paints, and pharmaceuticals. Compared to petroleum-based production methods, fermentation-based solvent production is more sustainable and environmentally friendly.
4. Cosmetic Industry
Fermentation technology in the cosmetics industry is primarily used to produce natural, efficient, and safe active ingredients such as amino acids, polysaccharides, and organic acids. These ingredients offer various benefits, including moisturizing, antioxidant, anti-inflammatory, whitening, and anti-aging effects. They meet consumer demand for green and healthy cosmetics while enhancing the product's market competitiveness.
5. Agricultural Field
The application of fermentation technology in agriculture primarily includes the production of biofertilizers and biopesticides . Through microbial fermentation, organic waste can be converted into efficient biofertilizers, while the metabolic products of specific microorganisms can be used to develop environmentally friendly biopesticides. These products not only help improve crop yield and quality but also reduce the use of chemical fertilizers and pesticides, promoting sustainable agricultural development.
6. Environmental Protection
In environmental protection, fermentation technology is mainly applied in wastewater treatment and the degradation of toxic substances. Microorganisms can use fermentation to convert organic matter in wastewater into harmless substances, achieving water purification. Additionally, fermentation technology can be used to degrade toxic substances in soil and water, reducing environmental pollution.
7. Material Science
The application of fermentation technology in material science has gained increasing attention. For example, microbial fermentation can be used to produce bioplastics (such as polyhydroxyalkanoates, PHA), which are biodegradable and can effectively reduce the pollution caused by traditional plastics. Furthermore, fermentation technology can also be used to produce biofibers and other bio-based materials.
8. Biofuels and Energy
The application of fermentation technology in biofuel production is mainly focused on the production of bioethanol and biohydrogen. By fermenting biomass (such as corn and sugarcane), bioethanol can be produced as an alternative to gasoline. Additionally, some microorganisms can ferment to produce hydrogen under specific conditions, providing a clean alternative for future energy sources.
Contract Fermentation Services
Strain Development and Optimization
Strain Screening : Utilizing advanced screening techniques, we select high-performance target strains from natural sources or strain libraries, laying a solid foundation for your project.
Strain Improvement : Through genetic engineering, mutagenesis, and other techniques, we enhance strain productivity, stress resistance, and stability to improve product yield and quality.
Fermentation Process Development and Optimization
Laboratory-Scale Research : Conducting small-scale fermentation studies in the laboratory to explore optimal media formulations, fermentation conditions, and process parameters, providing technical support for pilot and large-scale production.
Pilot-Scale Expansion : Scaling up successful lab-scale processes to pilot-scale trials to address potential engineering challenges in expansion, ensuring stability and reliability in large-scale production.
Process Optimization : Continuously refining existing fermentation processes to reduce production costs, enhance efficiency, minimize energy consumption and environmental impact, and improve economic and social benefits.
Fermentation Production Services
Preclinical Sample Production : Adhering to strict quality standards and regulations, we provide fermentation sample production for drug development projects, ensuring product quality and supply stability to accelerate the drug development process.
Commercial-Scale Production : With extensive fermentation production capacity, we offer large-scale manufacturing services to meet market demand and support the commercial success of your product.
Analytical Testing and Quality Control
With a comprehensive portfolio of analytical competences, we design and execute all the testing from raw materials to the final products. Our services include analysis method development and validation, stability study, structure confirmation, impurity preparation and characterization, reference standards preparation and characterization, physical and chemical properties characterization, cleaning verification and other modules.
Product Extraction and Purification : Employing advanced separation and extraction technologies (e.g., membrane separation, supercritical fluid extraction, chromatography) and purification techniques to ensure the required product purity and activity while optimizing processes to reduce costs and environmental impact.
Quality Testing and Analysis : Equipped with cutting-edge analytical instruments (e.g., HPLC, GC, LC-MS, microbial identification systems), we have established a comprehensive quality testing system to conduct thorough analysis of raw materials, intermediates, and final products throughout the fermentation process. We provide accurate and reliable quality data and reports to support quality control and process optimization.
From microbial to enzymatic bioconversion, we offer innovative solutions that enable the transformation of raw materials into valuable products, providing a sustainable alternative to traditional chemical processes.
Microbial GMP Production
Our microbial production systems comply with good manufacturing practice (GMP), equipped with state-of-the-art fermentation facilities and various downstream isolation and purification equipment.
Fermentation Control
BOC Sciences is passionate about quality assurance in every process, delivering high-quality products consistently. The quality control analyses are carried out within the pharmaceutical establishment, which operates a laboratory and equipment compliant with the GMP requirements. Our staff are also qualified and trained to use the different techniques implemented for this purpose.
Fermentation Toll Manufacturing
BOC Sciences undertakes fermentation toll production, utilizing fermentation expertise and facilities to produce the required fermentation products, allowing customers to focus on their core competencies and allocate resources more efficiently. Our investment in technology advancements environmental protection demonstrates our commitment to sustainable practices and responsible fermentation toll production.
Advantages of Fermentation Services
- Workers: 200+. Our team consists of experts who have been deeply engaged in the fermentation field for many years, possessing extensive professional knowledge and practical experience.
- Over 2,000,000 liters of large-scale fermentation capability and the downstream process are provided by our plants. We offer our clients with speedy turnaround time and a seamless manufacturing process.
- 40+ reactors of from 30-4000 L, 170+ reactors from 20 KL to 30 KL, 24+ reactors of >100 KL
- 2 Hydrogenation reactors (200 L, 4Mpa and 1000L, 4Mpa)
- We have batch and continuous sterilization of media, as well as the dedicated facility for strain preparation and storage with control.
- A broad range of downstream processing covers microfiltration, centrifugation, liquid/liquid extraction, ultrafiltration, evaporation and packaging.
- Full service package from intermediate to API, from fermentation to synthesis, from small molecule drugs to macromolecules.
- Flexible production capacities and well trained qualified staff, as well as supporting functions such as QA, Analytics and EHS.
- State of the art facilities covering various products like cytotoxic and sterile products.
- Investment in environmental protection measures and skills.
- Well-established quality system, which has passed through a series of official inspections and customer audits. Quality management covers the entire chain-R&D, purchasing, manufacturing, logistics and marketing. All employees participate in quality management.
| NMR | GC | SFC | MP |
| ICP-MS | HPLC | IR, FT-IF | Polarimeter |
| KF titrator | IC | UV-Vis | Stability chamber |
| UFLC-MS, UPLC-MS, HPLC-MS | X-ray crystallography | ||
Workflow of Contract Fermentation Manufacturing
BOC Sciences provides a seamless one stop process development service from concept to commercialization. We aim to help customers facilitate their project management and commit to meet their project timeline, supporting from lab trial to commercial launch. Every link is managed under strict confidentiality and proprietary agreements.
1. Project Consultation and Communication
Customers present their project requirements, and our professional team will engage in in-depth communication to understand product characteristics, quality standards, production scale, and other detailed information. Based on this, we will formulate a preliminary fermentation CDMO service plan and provide technical consultation and recommendations.
2. Contract Signing and Project Initiation
After both parties agree on the service plan, a formal cooperation agreement will be signed to clarify the rights and obligations of both sides. We will then quickly assemble a project team, develop a detailed project plan and timeline, and initiate the project implementation.
3. Small-scale R&D and Process Optimization
Small-scale fermentation experiments will be conducted in a laboratory environment to optimize and adjust fermentation process parameters, determining the best fermentation conditions. Simultaneously, product testing and analysis will be performed to ensure the product quality meets the expected goals. Based on the experimental results, we will provide technical support for pilot scale-up and mass production.
4. Pilot Scale-up and Process Validation
The fermentation process that has been optimized in small-scale trials will be scaled up to pilot scale for validation. Further process parameter optimization will take place, addressing any issues that may arise during scale-up, ensuring process stability and reproducibility. At the same time, product quality stability will be assessed to lay a solid foundation for large-scale production.
5. Mass Production and Quality Testing
Building on the success of the pilot scale, large-scale fermentation production will be carried out, strictly adhering to the quality management system for process control and product testing. After production is completed, the product will undergo comprehensive quality testing and analysis to ensure it meets the agreed-upon contract standards, and detailed quality reports will be provided to the client.
6. Product Delivery and After-sales Service
Qualified products will be delivered to the client on time, along with guidance and advice on product transportation, storage, and other aspects. Additionally, a complete after-sales service system will be established to promptly respond to customer feedback and needs, providing technical support and solutions to ensure customer satisfaction.
FAQ
1. What specific projects are covered by your fermentation CDMO services?
Our fermentation CDMO services cover the entire process, including strain selection and optimization, fermentation process development and optimization, fermentation production, product extraction and purification, as well as quality testing and analysis. We also offer customized services based on client needs. For example, BOC Sciences provides services ranging from genetically engineered strain construction, strain library establishment, small-scale process development and optimization, to pilot-scale process upscaling and production.
2. How do you ensure process stability and product consistency during fermentation scale-up?
Before scaling up, we carefully consider critical factors such as changes in sterilization methods, the impact of increased passage numbers due to additional seed culture stages, differences in mass transfer and shear forces, and variations in feeding strategies. Through pilot-scale studies, we fine-tune process parameters to closely align with large-scale production requirements. Additionally, we utilize advanced Process Analytical Technology (PAT) and Quality by Design (QbD) principles to continuously monitor and optimize key process parameters, ensuring process stability and product consistency.
3. How do you ensure that the quality of fermentation products meets standards?
We have established a rigorous quality management system that covers the entire process, from raw material procurement, strain selection, and fermentation production to product testing and delivery. Our facility is equipped with state-of-the-art analytical instruments, such as HPLC, GC, LC-MS, and microbial identification systems, to conduct comprehensive quality testing and analysis of raw materials, intermediates, and final products. Additionally, we set strict quality standards and testing protocols based on client requirements and regulatory guidelines to ensure product quality compliance.
4. What measures do you take if contamination occurs during fermentation?
If contamination occurs, we take immediate corrective actions, including halting fermentation, thoroughly cleaning and sterilizing fermentation tanks, identifying contamination sources, and implementing appropriate preventive measures. We also reinforce aseptic operation training, optimize fermentation parameters, and enhance strain resilience to contamination to prevent recurrence of similar issues.
