cGMP Production of Monoclonal Antibodies (mAbs)
Leveraging years of monoclonal antibody expertise
Monoclonal antibody (mAb) therapies have the potential to offer better specificity and safety than alternative treatments for several complex diseases, such as cancers and autoimmune disorders. In addition, they already have an established regulatory precedence and are relatively cost-efficient of produce. For these reasons many biopharmaceutical companies are currently building their clinical pipelines around monoclonal antibody platforms.
To start an efficient monoclonal antibody development program, you need an experienced partner to help you identify suitable candidates early. Then build a stable cell line, optimize the conditions and media and streamline the workflow.
We can offer you reliable and efficient delivery of monoclonal antibodies based on proven and robust technology platforms – and many years of experience. Our proven solutions are used globally for clinical and commercial scale manufacturing monoclonal antibodies.
Our proven solutions are used globally for clinical and commercial scale manufacturing monoclonal antibodies.
- Reliable and efficient delivery
- Extensive mAb experience
- Unique risk minimization-based approach
- Clinical and Commercial scale production
- Scale Out and Scale Up strategies
A new approach to mAb production
FUJIFILM Diosynth Biotechnologies offers a novel risk-minimizing approach to mAb production, designed from the ground up to deliver a dependable and efficient supply of monoclonal antibodies.
Our starting-point and focus – from clinical development through cGMP production and commercialization – is to minimize the host of hazard pathways over the mAb therapeutic lifecycle, thereby minimizing risks to timeline, quality, development, regulatory and the business.
Early on, multi-well plates and micro bioreactors are used to screen cell lines to provide visual evidence of monoclonality in an environment that is very close to that of the production bioreactor. This provides rapid insights during the discovery phase, to assist you in the identification suitable candidates with high antigen reactivity and the desired functionality.
The workflow and conditions can then effectively be optimized during process development to get you earlier access to monoclonal antibody cGMP manufacturing. In order to avoid surprises during scale-up, we use the same analytical equipment and process equipment through the entire process;
We designed our approach with the customer in mind, from the ground up, to discover and deliver a dependable supply of monoclonal antibodies at any scale.
- Let us develop a high-quality stable cell line displaying monoclonal antibodies for you – based on our long Cell Culture experience and expertise – by integration with Apollo™X Mammalian Expression System
- Or start your early phase program by transfer of an existing cell line to us.
Scale Out cGMP production of monoclonal antibodies
Our high-throughput manufacturing facility is scaled to multiple 2,000L bioreactors with an additional downstream suites. We employ single-use technologies for upstream and downstream process development and scale-up of mammalian cell culture-based monoclonal antibodies, leveraging process closure analysis.
All consumables are available in the onsite warehouse with resupply scheduled with the vendors. As your manufacturing partner, we will assume responsibility for having backup materials for platform runs. Resupply batches can be made very rapidly as raw materials and consumables will be in stock.
The complete solutions program includes implementation scripts, detailed schedule of activities, standard consumables, advanced analytics, rigorously vetted base documentation, streamlined contracts and attractive licensing terms.
Resupply batches can be made very rapidly as the cell line, batch records and consumables will be in place. The next open slot can be utilized which should be a short time given that bioreactors can be added as needed to maintain open capacity.
Make sure you meet the critical timelines on your CMC journey by selecting an experienced and reliable partner.
- Support mAb therapies from Early to Late Phase Clinical Stage all the way to Commercial Manufacturing
- Extensive experience at all clinical phases (from pre-clinical development to late phase to commercial production).
- ‘Flexible solutions across multiple sites.
- Option to align existing processes with common Fujifilm Diosynth Biotechnologies monoclonal antibody processes to maximize operational efficiency.
- Analytical Platform Methods already developed, ready for implementation, mitigating Analytical Development related risks.
- Analytical Methods supported by extensive characterization capabilities. Rapid access to resupply batches
Summary of CDMO services in monoclonal antibody manufacturing
Efficient monoclonal antibody manufacturing and scale-up
- Reliable and efficient delivery of monoclonal antibodies
- High-throughput manufacturing approach provides built-in capacity access to support critical deadlines
- Robust and easily optimized from Early Phase programs to Late Phase
- Earlier access to mAb cGMP manufacturing and disposition
- Option to align existing processes with common Fujifilm Diosynth Biotechnologies mAb processes to maximize operational efficiency
Flexible cell line expression system support
- Program start at cell line development – or by transfer of existing cell lines
- Built-in support for ApolloTM Mammalian Expression System
Reliable and safe manufacturing
- Dedicated specialist team with extensive experience from all phases – from pre-clinical development to late phase and commercial production
- Pre-existing and proven analytical methods for minimum analytical risk – ready for efficient implementation
- Well defined manufacturing operational approach for efficient and reliable production
- Ready for validation
- Ready to implement/assess upstream and downstream process platforms
- Flexible solutions across multiple sites.
Monoclonal antibody-dedicated cGMP Facilities
- mAb-dedicated cGMP facilities, based on single-use technologies
- High-throughput manufacturing approach provides built-in capacity access to support critical customer deadlines
- Our mAb programs do not compete with non-mAb programs for manufacturing capacity
- Common platforms e.g. GE 500L & 2000L SUBs.
- Facilities designed to support long-term commercial manufacturing
- Supply chain risk mitigation to avoid program delays
Dedicated Large Scale Cell Culture Facility
- 6 X 20,000L stainless steel capacity for monoclonal antibody production