Antibody Drug Conjugates (ADCs) are the combination of a monoclonal antibody (mAb) with a cell-killing cytotoxic drug. The antibody acts as a delivery system and selectively targets the tumour cells. Once reached the tumour, the ADC releases its cytotoxic payload by chemical or enzymatic processes, eventually leading to the death of the targeted cell. The recent approvals of Adcetris® for Hodgkin's lymphoma and Kadcyla® for Her2-positive breast cancer have provided further evidence of the potential of ADCs in the treatment of cancer. The growing number of drug conjugates in clinical and preclinical development spurred the need for high quality manufacturing to bring new products into the clinic and ultimately to the public.
To better support customers involved in the development of new ADCs, CARBOGEN AMCIS recently completed the construction of a new clean room dedicated to the conjugation of biological molecules and small highly potent molecules at the Bubendorf site. This recent investment positions CARBOGEN AMCIS as industry leader and outsourcing partner for complex conjugation projects and ADCs.
CARBOGEN AMCIS' new ADC clean room operates according to cGMP standards and can handle compounds at OELs ≤ 10 ng/m³ 8h-TWA, as our most recent containment testing efforts have shown. Highly potent toxins are often used as warheads for new generation targeted cancer treatments, such as ADCs.
The new clean room (100 sqm floor space) contains:
- A separate Grade D area for equipment storage and sanitization, reagent and buffer preparation
- A Grade C area for conjugation, purification, and packaging processes
- Separate material and personnel airlocks to access the Grade D and C areas
- Pressure Cascade (+30 Pa, +15 Pa, 0 Pa, -15 Pa)
For a 360° virtual tour of the Grade D Clean Room click here.
For a 360° virtual tour of the Grade C Clean Room click here.
For more information on CARBOGEN AMCIS Conjugation Services for ADCs please consult our brochure here.