Monoclonal / Dual Antibody Production: Suitable for Long-term Cell Culture, Guaranteeing Product Uniformity
Monoclonal antibody production relies on the long-term stable culture of mammalian cells such as CHO cells and HEK293 cells ( usually 14-21 days ) , which requires high requirements for sterility, parameter stability and contamination prevention and control of the reactor --- GMP stainless steel reactor adopts 316L medical grade stainless steel tank with mirror polishing ( Ra≤0μm ) and double mechanical sealing.
GMP stainless steel reactor adopts 316L medical grade stainless steel tank, mirror polishing ( Ra ≤ 0.4μm ) without dead corners, with double mechanical seals and sterile shaft seals, to eliminate microbial contamination and cell adhesion in the process of cell cultivation;high-precision temperature control system ( ± 0.1 ℃ ) and pH closed-loop control ( ± 0.05 ) , to maintain the optimal cell logarithmic growth period. high-precision temperature control system ( ±0.1℃ ) and pH value closed-loop control ( ±0.05 ) to maintain the optimal environment during the logarithmic growth period of the cells and reduce the decline in antibody expression due to fluctuations in parameters; · is equipped with on-line cell density monitoring ( e.g., NIR near-infrared probes ) and automatic replenishment system, which can regulate the nutrient supply of glucose, glutamine and other nutrients in real time to ensure the consistency of antibody titre and purity between batches, and easily meet the quality requirements of FDA/EMA for biosimilar drugs. requirements of FDA/EMA for the quality of biosimilars.
At present, these reactors have been widely used in the commercial production of monoclonal antibody drugs such as adalimumab and PD-1 inhibitors, supporting 20L-5000L large-scale tanks, helping pharmaceutical companies to improve production capacity.
Vaccine Production: Compatible with multiple expression systems, meeting the needs of rapid process switching
Vaccine production covers a variety of types such as viral vector vaccines ( e.g. adenovirus vaccines ) , recombinant protein vaccines ( e.g. HPV vaccines ) , inactivated vaccines, etc., which requires the reactor to be adapted to different expression systems such as bacterial, yeast, insect cells, etc., and to meet the aseptic requirements of frequent process switching.
For viral vector vaccines: the reactor is integrated with a highly efficient aeration and stirring system, precisely controlling the dissolved oxygen ( DO ) and stirring speed to avoid shear damage to viral particles, and supporting low temperature culture ( 30-32℃ ) to meet the needs of viral replication;for recombinant protein vaccines: equipped with For recombinant protein vaccines: equipped with steam in place ( SIP ) system, 121℃ high temperature sterilisation with no dead angle, fast cooling after sterilisation, which can quickly start the next batch of yeast/bacteria fermentation and shorten the production cycle; meets the GMP requirements of ‘one-way flow’ and ‘traceability’ for vaccine production: the pipeline of the equipment adopts sanitary pipeline to avoid damage to the virus particles. meets the GMP requirements of ‘one-way flow’ and ‘traceability’ for vaccine production: the equipment piping adopts sanitary quick-fit connection, key parameters ( temperature, pressure, sterilisation time ) are automatically recorded and stored, and audit trail is supported, so it can easily pass the GMP certification of State Drug Administration ( SDA ) .
Cell and Gene Therapy ( CGT ) : Meet the dual requirements of closure and scale-up
CAR-T cell, stem cell therapy and viral vector ( AAV, lentivirus ) gene therapy products, the reactor closure, low risk of contamination and ‘from small pilot to pilot’ expansion of the requirements of the demanding - -
Closed design: the reactor is equipped with aseptic receiver system and disposable sampling bag, avoiding the contact between cells and the outside world throughout the whole process, reducing the risk of exogenous contamination in the process of CAR-T cell cultivation;
Modular capacity expansion: support 50L-500L pilot scale, process parameters ( such as temperature, CO ₂concentration ) can be seamlessly connected with the laboratory pilot equipment to reduce process deviation during technology transformation.
Adaptable to Suspension / Adhesion Cells: For adherent stem cells, it is compatible with the microcarrier culture system, which ensures the uniform suspension of microcarriers and enhances the efficiency of cell adherence through the precise control of stirring speed; for suspended CAR-T cells, the low shear stirring design avoids cell damage and maintains the high cell viability. For suspended CAR-T cells, the low shear mixing design avoids cell damage and maintains high cell viability.
Microbiopharmaceuticals: Suitable for antibiotics and probiotics, combining efficiency and compliance
In traditional microbiopharmaceuticals ( e.g. antibiotics, probiotics ) , GMP stainless steel reactors have become the preferred choice for compliance production due to their corrosion resistance and efficient temperature control
For antibiotic fermentation ( e.g. penicillin, cephalosporins ) : the reactor is suitable for the fermentation of antibiotics ( e.g. penicillin, cephalosporins ) . For antibiotic fermentation ( e.g. penicillin, cephalosporins ) : the reactor is resistant to acidic fermentation environment, equipped with efficient anti-foaming system to avoid foam-induced escape and contamination of contaminating bacteria, and supports high temperature induction ( e.g. expression induction at 42℃ ) to improve antibiotic yield;
For medicinal probiotic ( e.g. Bifidobacterium, Lactobacillus ) : the reactor is supported with anaerobic / microaerobic environment control, which can accurately control the concentration of oxygen in the process, and guarantee the number of viable probiotic bacteria. The equipment is easy to clean and resistant to multiple sterilisation, which is in line with GMP standards for medicinal probiotics.
Yocell can provide GMP stainless steel reactors with customised configurations to help customers comply in the biopharmaceutical field.
