What is ADC
The conventional antibody-drug conjugates (ADCs) consist of monoclonal antibodies, a linker, and a payload. Via the linker, the high-potency, usually chemotherapy drugs, small molecules can be loaded onto the antibodies, which can then carrier the payload to the specific therapeutic target and be active via cytotoxic mechanism. This combination in the structure aspect determines that ADCs can pose various challenges in CMC (chemistry, manufacturing, and control), from chemistry capability in handling complex structures to the know-how for manufacturing cytotoxic compounds, as well as for bioconjugation production, formulation development, and bringing the drug substance into the sterile fill and finish manufacturing. An experienced CDMO can save customers a lot of energy, cost, and time, especially they can work with a CDMO provides a one-stop-shop solution like Formosa Laboratories.
One-stop service
Formosa Labs provides a one-stop solution to client’s ADC projects. One-stop service means adaptive planning, cost management, and time efficiency for our client. In terms of ADC development, Formosa Labs supports every aspect from the design and creation of ADC, linker-payload chemistry, to the GMP manufacturing and filling of injectable drug products.
ADC Services in Formosa Labs:
- Antibody development and manufacture
- Peptide and polymer drug conjugation
- Linker-payload design, synthesis, and manufacturing.
- Bio-conjugation and purification (TFF, chromatography)
- Cytotoxic liquid-filled and lyophilized product from pre-formulation studies to manufacture
- Regulatory support
Experiences in ADC
10 years experience in ADC development15 years experience of high potency API
18 active projects under clinical development
With more than 10 years experience of high potency API and ADC, Formosa Labs starts biosimilar project of Kadcyla in 2013. Per CDMO business, we have supplied the clinical trial materials to the US, EU, and Asia regions. Formosa Labs expands the capacity of ADC production and reach 50 kg annual capacity for our customer in the next decade.
ADC and Linker-Payload Platform
- Our high potency/bio-conjugation labs in Formosa Labs support the ADC research samples from candidate design to product delivery.
- The proprietary linker-payload platform of Formosa Laboratories aims to provide high DAR (drug-antibody ratio) ADC product. With this platform, we can delivery ADC candidate in 1 month.
- To the aspect of handling the complexity of in ADC and high potency API, Formosa Labs has the ability to synthesize cytolysine in a 40-step synthesis process. With our in depth chemistry experience, we walk along with with our customer for their ADC from beginning.
