Approaching payload process development using QbD
Thomas Matt , Senior Manager R&D Chemical Division at Cerbios, looks at some practical experiences in projects for ADC payloads.
"During all stages of R&D activities, a process has to be developed, while also considering the containment system required and the design of the plant, so as to ensure reproducible manufacturing, of the compound with defined quality and yield, while also keeping safety, costs and timelines under control.
For a CDMO, the work generally starts withlaboratory procedures.The quality requirements and the batch sizes of the material increase depending on the intended use. In the early stages, the target quality of payloads is often not yet totally defined; requests for HPLC purity of at least 90% with single unknown impurity of less than 2% (HPLC) are common. Due to the chemical complexity of the payloads, which are derived from auristatins, such as monomethyl auristatin E or F, maytansinoids, PBDs or other toxins, HPLC purity profiles with up to 20 impurity peaks or even more, mostly with unknown structures, are not unusual at this stage.
Courtesy of Specialty Chemicals Magazine, March 2019 Edition.
You can download and read the full article following this link.
Cerbios is a privately held company located in Lugano, Switzerland, that specializes in the development and manufacture of both chemical and biological APIs for its partners world-wide.
Exclusive, third-party manufacturing services are offered by the Chemical Division for HPAIs and by the Biological Division for monoclonal antibodies, recombinant proteins and pharma probiotics.
Cerbios provides full CMC support to its world-wide partners, including the supply of cGMP clinical batches, registration/validation material and commercially manufactured APIs. Paramount to this is the ability to supply all of the technical documentation and support necessary for a successful registration. Cerbios’ commercial products are marketed worldwide but primarily in Europe, USA, Japan and India.