Antibody Drug Conjugates (ADC)
Targeted therapies, such as monoclonal antibodies, are an important part of cancer drug development. Monoclonal antibodies may be used either unlabeled or conjugated with radioactive isotopes, chemotherapeutics, or toxins to create more potent therapeutic agents. Antibody Drug Conjugates (ADC) are monoclonal antibodies (mAbs) attached to biologically active drugs, usually chemotherapeutic agents, by chemical linkers with covalent bonds.
With our experience in chemistry in addition to our biologics expertise, MabPlex provides full services for antibody drug conjugates. We are one of the leading companies in the world providing this technically challenging service from development to commercial production at one location.
Our services begin by using our state-of-the-art antibody development and production facilities to develop and produce your antibody of choice. Next, our chemistry experts synthesize the linker of choice as well as the correct cytotoxin. Then our process development department develops and scales up conjugation process. Finally, our manufacturing team completes the entire production under the cGMP conditions.
MabPlex offers one stop integrated development services ranging from the development of antibodies, linkers, and cytotoxins to the production of efficacious ADC drugs. Additionally, we implement innovative linker technologies to ensure that cytotoxins effectively conjugate to the antibodies and that the cytotoxins are only released into the target cells. We are fully confident that our first class service can significantly speed up your ADC drug development process. MabPlex effectively shortens the product life cycle from development to commercialization through the management of traceable batch records with our quality by design approach.
- Cytotoxin development and synthesis.
- Innovative linker development and synthesis
- Optimization studies
- Antibody production and optimization
- Antibody protein pretreatment before conjugation
- Antibody conjugation with cytotoxin by a chemical linker.
- Small molecule and linker synthesis
- Successful scale-up experiences from milligram to kilogram scale ADC drug production
- Stable and efficacious ADC products
Antibody Drug Conjugation Large Scale
Our ADC service ensures consistent and controllable linkage between drug and antibody in large scale production. Under our GMP managed process control, we are able to guarantee the drug to antibody ratios (DAR) and the consistency of each ADC production batch.
GMP manufacturing capabilities
- An exclusive conjugation technology
- Broad range of conjugation scales from 10L to 500L, ensuring we meet all client needs from clinical research to commercial production
- Large scale cytotoxin and linker synthesis under GMP conditions
- Conjugation process in large scale (up to 500L reaction vessel) with stable and effective linkers
- Accurately controlled ADC conjugation processes under GMP environment with complete QA/QC supervision
- Mature linker and cytotoxin technologies
- Extensive experience in ADC conjugation and process scale-up
- Assisting our clients in IND application filing of ADC drugs
From the development to the commercial manufacturing of your ADC, MabPlex delivers your ADC as promised on time at top quality.