The development of an antibody drug conjugate (ADC) represents a marriage between the disciplines of biology and chemistry. The creation of an ADC involves a combination of bioprocess manufacturing techniques with traditional synthetic chemistry skills to make the small molecule part, then conjugating it to the biologic.
SAFC has positioned its ADC manufacturing within its large molecule plant in St Louis, rather than housing it in a small molecule facility. This gives the advantage of having the knowledge in handling biologics, as well ready access to the expertise and extensive tool kit required for analytical characterisation capabilities to manufacture and test a complex biologic.
Apart from the manufacturing challenges, ADCs pose interesting questions in the regulatory arena. As the biologic and the HPAPI can both be considered to be active ingredients, they both need to be characterised and produced according to GMP rules before they are brought together in the final, conjugated molecule that is delivered as a therapeutic.
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