Antibody-drug conjugation (ADC) technology uses monoclonal antibodies or other biologics to deliver conjugated highly-potent APIs (HPAPIs) to targeted cells. In conjugated form, the HPAPI exhibits more selective cytotoxicity, thereby, sparing non-target cells from many of the toxic effects.
For antibody drug conjugates (ADCs), SAFC?, a member of Sigma-Aldrich, can conjugate biological molecules with high-potent APIs (HPAPIs) to meet pharmaceutical industry demands for development of new oncology products that are more targeted and exponentially more powerful.
Often cytotoxic or neurotoxic, HPAPIs must be managed with the highest level of containment. SAFC facilities incorporate appropriate room pressurization, airlocks, ventilation and isolators to ensure proper handling of these highly-potent materials within cGMP suites designed especially for biologics manufacturing process:
- SAFC manufactured HPAPIs;
- Traditional (non-potent) APIs from SAFC or the customer;
- SAFC or customer manufactured linkers with unique conjugation properties;
- Proven and experienced quality assurance oversight for HPAPIs;
- Clinical trials APIs manufactured to ICH Q7A guidelines;
- Conjugation for linking of non-potent APIs to other biologic carriers, including polyamino acids or polynucleotides.
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