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Pharmaceutical Development for ADCs: Not as Simple as ABC

Formulation, process, and analytical development for antibody-drug conjugates, or ADCs, is complex. While the development of an aqueous solution formulation may be preferred over a lyophilized product, it is useful to initially pursue a dual path and develop drug product formulations for both a sterile solution and a freeze-dried solid presentation, ultimately choosing the most successful candidate for final development. An antibody-drug conjugate, or ADC, consists of a monoclonal antibody (mAb) joined to a highly potent or cytotoxic drug by a stable, chemical linker with labile bonds. The antibody is targeted to attach to an antigen on the surface of a tumor cell. Once the connection is made between surface antigen and antibody, the antibody and linked drug are incorporated into the tumor cell. The drug is then cleaved from the antibody, and goes to work to destroy the tumor cell. Once internalized, the amount of “payload drug” required to cause cell death is relatively small. For that reason, ADC’s are generally better tolerated by patients than more traditional forms of chemotherapy.

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Spotlight

Wallace Pharmaceuticals (DC)

The Wallace Group is a privately owned Pharmaceutical & Biotechnology Group headquartered in Goa, India. Incorporated in the late 1960s as a joint venture with Carter Wallace Inc. and Menezes family, the Wallace Group is primarily engaged in the manufacture and marketing of formulation products in India as well as abroad. The Group comprises Wallace Pharmaceuticals, Indi pharma and Goodwin Biotechnology Inc. The Wallace Group employs over 2300 personnel with offices and facilities in several key locations in India and around the world. The Wallace Group comprises of Wallace Pharmaceuticals, Wallace Laboratories, Indi Pharma, Goodwin Bio Tech & Trusts.

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