In recent years, the number of immunotherapies based on monoclonal antibodies (mAb) and recombinant proteins has increased rapidly. The optimization of cell lines and cell culture, the enhancement of downstream purification, and the adoption of new technologies continue to promote productivity improvements and reduce production costs. A powerful monoclonal antibody production platform can accelerate the speed of entering the clinic, can quickly develop the process, and support the rapid transition to full-scale production.
Other antibody constructs, such as Fc fusion proteins, bispecific monoclonal antibodies, and antibody-drug conjugates (ADC), require unique modifications to these model platforms. However, these and future treatments still face similar production and purification challenges. The same solution can be reorganized and optimized to form the basis of any future process.
The development of new processes always has the greatest space to adopt new technologies, but there are still opportunities for existing processes to develop within the limits of manufacturing approvals. The benefits of single-use technology can be applied to most unit operations and may even have a significant impact on non-critical processes. No matter what you need, you can find the right choice for your process in our complete solution.
Monoclonal Antibody Production
There is no single, best manufacturing solution. The method applicable to one process or one manufacturing location may not be applicable to all other processes. Alfa Chemistry has a unique breadth and depth of product portfolio that can support all your monoclonal antibody production options, support traditional manufacturing methods and disposable alternatives, and further intensive technologies through automation, continuous processing, and integrated processing.
Fig.1 The production of monoclonal antibodies. (Rajewsky K, et al. 2019)
In addition to technology, we also have the knowledge and product portfolio that can help accelerate mAb process development and enhance existing processes through the integration and adoption of disposable technologies. Let us share our knowledge, we can quickly optimize your process together, prove that it is ready for industrial-scale production, and help you speed up time to market.
Cell Culture
Disposable Bioreactor
Pre-irradiation consumables are combined with process monitoring, hardware, and software to control and simplify the preparation and growth of cell cultures. This simplicity minimizes pollution incidents and supports rapid turnaround to increase productivity levels.
Media Preparation
Upstream processes need to provide a large amount of aseptic process media in a timely manner. Preparation, transmission, and connection all need to be carefully controlled to minimize process risks.
0.1 µm filter for mycoplasma control
Mixer for medium preparation
Aseptic connector for simplifying the aseptic connection of disposable components
Air Filtration
It is essential for the safety and sterility of cell culture. Choosing a reliable air filter means you can focus on these details with confidence.
- Steamable filter with PTFE membrane
- Autoclavable capsule with PTFE membrane
- Irradiable capsule with PVDF membrane
Cell Harvest
The classic combination of centrifugation and filtration for cell harvesting and clarification requires repeated optimization. Deep filtration is usually used to clarify the liquid after centrifugation to support a variety of cell harvests. These include an optimized disposable depth filtration platform to replace centrifugation, which can provide a simple, scalable solution and provide powerful performance in a wide range of mAb processes.
Various depth filter media can be optimized for each process or used as a platform technology to clarify various cell densities and viability.
Chromatography
The combination of multi-stage chromatographic purification provides antibodies of consistent purity to meet the key quality attributes required to ensure drug safety.
Membrane
The capture and purification of antibodies and recombinant proteins requires a series of uniquely specific ligand chemistries and substrates to achieve the required purity as simply and economically as possible. The ideal purification platform can achieve this purity in a variety of processes with minimal buffer adjustments.
Virus Safety and Control
Virus Filtering
Removal of all viruses by size exclusion is a powerful virus control that can be simply added to most processes to achieve high log reduction values (LRV).
- High flow virus filter, which can achieve robust and high LRV under various mAb and fluid conditions
- Virus pre-filter, which can ensure and extend the performance of the virus filter
- Steady flow virus filter for complex contaminated fluid
Filteration
Filtration plays an important role in controlling the bioburden throughout the process, and is essential in protecting the cell culture and ensuring the sterility of the final drug substance and the final drug product.
- Sterile filtration: For the key points in the process and the highest assurance of bioburden control, 0.2 µm sterile-grade filtration provides the required sterility assurance.
- Bioburden control: For non-critical fluids, such as buffers, bacteria retention and filtration do not fully meet the requirements of sterilization levels. We provide filter capsules for reducing bioburden.
- Mycoplasma control: When potential contaminants are known to penetrate traditional 0.2 µm filters or when additional guarantees of sterility are sought, 0.1 µm filters can provide the required retention level.
Reference
- Rajewsky K, et al. (2019). "The Advent and Rise of Monoclonal Antibodies." Nature. News & Views.