Microbial GMP Production

BOC Sciences is a lead CDMO service supplier. We provide a wide range of fermentation services based on microbial strains such as E. coil, Pichia Pastoris, Saccharomyces cerevisiae and others. 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.

BOC Sciences provides one-stop fermentation service to customers for industries around the world. We have extensive expertise in producing active pharmaceutical ingredients (APIs), intermediates and other chemicals or biochemicals for the pharmaceutical industry. In addition, we offer clean and sustainable solutions for customers in the food and cosmetic industry through our microbial fermentation platform.

Example of Microbial Fermentation Production Capacities

One-Stop Fermentation Production

With over 20 years of experience in fermentation technology development and microbial production, BOC Sciences is the world's leading partner in the production of microbial biologics for our customers. Our one-stop fermentation service benefits our customers with the reduction of costs and time.

Microbial strains

• Strains improvement to enhance target compound production capability of individual strains.
• Microbial cell banks construction that store specific genomes of cells for future use for medicinal or other purposes.

Downstream Process

• Purification and separation by chromatography and membrane systems.
• Refolding or denaturation of Proteins.
• Recovery of antibodies, proteins and other high-value products in high levels.

Our Microbial GMP Production Capabilities

BOC Sciences has strong capability in the development and manufacturing of microbial products. We are able to develop, qualify, and manufacture fermented products by using quality-by-design (QbD) principles.

Extensive experience

• A variety of microbial strain systems range from prokaryotic to eukaryotic systems.
• Microbial-based protein expression technology is used for efficient production of therapeutic proteins or alternative proteins.

Advanced equipment

• Equipment of upstream process for fermentation, centrifugation and filtration.
• Fully automatic fermenters of different volumes from 4,000L to 12,000L, over 100,000 liters capability in total.
• Recovery and downstream equipment, ranging from industrial-scale chromatography systems, membrane systems to larger scale continuous centrifuges.
• Equipment for waste treatment.

Cleanroom and sterile operation

• Air temperature and humidity levels and microorganisms within cleanroom are tightly controlled.
• Cleanroom reserved segregated personnel and material airlocks, and areas performing different functions are segregated from each other.

• Our GMP fermentation teams were trained by developers regularly to ensure full compliance operation with GMP requirements.

Quality assurance and EHS compliance

• Process control: raw material and component control, raw material release, process validation, deviation management, in-process and release testing, batch release, and production tracking.
• Commercial production facility: material and personnel flow, cleaning, environmental monitoring.
• Environment, health & safety: general safety and hygiene, personnel safety, routine inspection for confined equipment, and segregated waste handling.

Workflow of Microbial GMP Production

BOC Sciences has always been committed to ensuring GMP compliance in the microbial manufacturing process. We maintain a close working relationship with our customers throughout every aspect of the project.

• Project design and evaluation
• Strain selection and development
• Media and process optimization
• Fermentation and scale-up
• Microbial GMP production
• Project delivery