With more than 30 years of experience in bio-conjugation, SAFC is a leading expert for the conjugation of highly active molecules to monoclonal antibodies for the development and manufacture of ADCs.
Antibody-drug conjugation technology uses monoclonal antibodies or other biologics to deliver potent or highly active pharmaceutical ingredients (HAPIs) to targeted cells. In conjugated form, the HAPIs exhibit more selective cytotoxicity, thereby, sparing non-target cells from many of the toxic effects and improving the safety profile.
SAFC has the expertise needed to deliver solutions for your ADC or bioconjugate.
For antibody-drug conjugates, SAFC provides development and manufacturing services of commercial-scale HAPIs, linkers and conjugation, respectively at the SafeBridge®-certified Madison, WI (USA) and St. Louis, MO (USA) facilities. Extensive analytical testing and characterization for both APIs and biologics are available to customers. Highly experienced Quality and Regulatory support for EU, US and Japan is provided with Drug Master Files (DMFs) in over 30 countries.
With over 25 years of experience working with highly-active pharmaceutical ingredients (HAPI), SAFC can handle your complex and highly-active molecules.
SAFC’s clinical ADC manufacturing facility was purpose-built for the handling of HAPIs, antibodies, linkers and for performing complex conjugation processes in a cGMP suite featuring isolators and specialized handling equipment.
A commercial scale manufacturing suite is underway with completion expected mid-2015, including:
SAFC’s comprehensive ADC solutions include analytical and process support at all stages of drug development and manufacture.
Complete analytical support, from development of specifications, risk assessment, implementation of process controls and validated cleaning procedures. In addition, our analytical capabilities offer:
From evaluation to execution, SAFC‘s highly skilled and dedicated project managers are responsible for coordinating multi-disciplinary teams, international site activities and timelines:
Research. Development. Production.
We are a leading supplier to the global Life Science industry with solutions and services for research, biotechnology development and production, and pharmaceutical drug therapy development and production.