4th Dimension is a global, world class Contract Development and Manufacturing Services (CDMO) service provider offering a range of continuous bioprocessing and supporting services to advance your drug development program. We are the only US-based CDMO exclusively focused on continuous bioprocessing. Our platform processes are established with the end goal in mind: to provide a path to producing your product in a commercial continuous process, in your facility or ours.
Early Development Program
Many virtual and emerging companies would like to have access to early development services prior to committing to a full CDMO project. Our pre-CDMO development program provides cell line development and analytical services and an early assessment of your product to advance your drug development program to the next stage.
Continuous Bioprocessing Assessment Programs
This program provides a suitability assessment of your product for use in our 4D continuous manufacturing platform
Non-GMP Continuous Bioprocessing Line
We will establish a non-GMP manufacturing line for you and provide you with the process development knowledge and know how to manufacture your product for GLP or toxicology studies.
The 4D continuous manufacturing platforms are a series of pre-determined manufacturing platforms operationally tested in the 4D Sandbox and developed to move toward integrated, single use end to end continuous manufacturing. Our number one goal is to use these platforms to increase your speed to clinic.
The qualities which define each 4D platform are consistent and achievable. These defining characteristics are:
- Single use, with pre-sterilized components wherever possible
- Fully integrated design incorporating process analytics with the production lines
- Automated operation with integrated quality metrics
- Fully electronic batch records and information capture; uploading to supporting Module 3 of the CMC section of the IND
- Eventually, real time batch release of drug substance
The 4th Dimension MabFab™ platform is a continuous, single use manufacturing platform for the manufacturing of Monoclonal Antibody drug substance. Monoclonal Antibodies are our first fab as they represent over two thirds of all biopharmaceutical sales in 2019, have had double-digit growth rates over the past decade and account for 70% of current pipeline in various stages of development.
Why begin with a MabFab™ continuous platform? We know how to manufacture mAbs really well; they remain a high growth market, there is a need for manufacturing flexibility without additional capital investment and speed to clinical remains paramount. There is presently a lack of access for virtual and emerging companies to manufacturing capacity designed for early tox programs using continuous approaches. There is also a lack of ability to implement continuous approaches in large biopharma companies during subsequent clinical scale up due to the structure of their existing manufacturing networks. We believe an outsourced option for continuous manufacturing of mAbs using a robust pre-detemined continuous platform will enable the industry to move forward with continuous approaches, bringing the cost of manufacturing on par with the largest fed batch mAb manufacturers in a US based, small flexible facility.
The VectorFab™ is a continuous manufacturing process under development for AAV (Adeno associated virus) a critical component in the manufacturing of gene therapies. Although capacity is rapidly being added, we believe a small footprint continuous approach will make it feasible to choose either an outsourced model of manufacturing or an internal tech transferred VectorFab to support gene therapy manufacturing and minimize the risk of manufacturing delays. Please contact us for more information on this program.
Our FutureFabs will offer solutions to drug companies for outsourced, automated and efficient continuous manufacturing for recombinant proteins using a unique approach that allows for minimal changes to the platform with each new biopharmaceutical project. There are also additional platforms under consideration in area that demand rapid scale up and deployment, such as vaccine manufacturing. In all cases, our platforms seek to fill an industry need for speed to clinic, flexibility, cost efficiency and importantly, easily scalable capacity.
Each 4th Dimension FutureFab will provide a streamlined production line approach using extensive automation, reduced materials and manufacturing footprint and 24/7 operation that can be flexibly employed to meet demand.
In all cases, 4Ds FutureFabs will address:
- Time to Market/Clinic
- Flexibility; Production on demand
- Capital requirements and timing
- Improved control of product quality
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