Cabogen Amcis, a contract manufacturing organisation (CMO) owned by India-based Dishman Pharmaceuticals and Chemicals, this week signed a long-term lease agreement with chemicals and biotech firm Bachem to take over a high-containment unit in Vionnaz, Switzerland.
The facility is fully equipped for the development and small scale cGMP manufacture of highly potent drugs and drug-linkers - one of the main components of an ADC - Carbogen Amcis told Biopharma-Reporter.com and will help fulfill growing customer demand for ADC development and manufacture.
“In the last 18 to 24 months, the ADC market gained momentum, well beyond the demand we have experienced in the last 10 years, spurred by large pharma and small biotechs,” Dr. Alan Fischer, Director of Technology, told us.
“Clinical results have showed that ADCs can recognize and target cancer cells leading to their death with fewer side effects for the patient,” and was the main driver in both this expansion and an investment last year which saw the firm set up a dedicated clean room and clinical supply suite at its plant in Beubendorf, Switzerland.
The Vionnaz plant will complement Bubendorf, which caters to larger cGMP manufacture projects and, according to Fischer, supports the coupling of biological material and the drug-linker moiety in an aseptic environment.
The Vionnaz facility includes a process development laboratory, a dedicated QC laboratory and two production units fitted with reactors up to 30 L, as well as equipment for lyophilisation and chromatography.
Flexible manufacturing approach
Carbogen Amcis has over 200 customers on its books and therefore needs to be flexible with its chemistries and philosophies, especially for ADCs. “Therefore, we use equipment fit for purpose, depending on the project and customer needs,” Fischer said.
This includes single-use technology which, like other biomanufacturers, Carbogen Amcis is implementing alongside more traditional systems.
“For example, we have single-use equipment, bags, and reaction containers besides fixed installations like isolators, glove boxes, laminar flow benches, walk-in hoods and freeze dryers (with single use Lyogards, injection vials and syringes),” we were told.
“Tangential flow filtration and chromatography are supported by a mix of fixed installations (like pumps) and single project use columns (like the Biotage system for example), membranes and tubing.”