UK-based ADC Biotechnology is developing a new downstream bioconjugation process for the creation and manufacture of antibody-drug conjugates (ADC).
The new method includes simultaneous conjugation and antibody purification at later phases of the downstream processing (DSP), instead of carrying out bioconjugation after the production of the mAb and cytotoxic.
It is expected that the downstream bioconjugation will potentially reduce time at the antibody manufacturer, while the downstream processing and conjugation service take place at the bioconjugation CMO.
The firm estimates that this entire simplified process will cut down around three months in terms of development and resources, along with a generation of large cost savings.
ADC Bio CEO Charlie Johnson said: “The major benefit, and the reason this approach will prove so disruptive, is that it will save several months of manufacturing time and up to 25% of the overall costs.
“But it will require much of the industry, with its current ingrained manufacturing methods, to re-evaluate exactly how it structures the supply chain that often uses three CMOs.”
During the new method, the conjugation is set to begin with antibody supernatants and will eliminate the extensive chromatographic purification required for purifying antibody.
As the method replaces costly Protein A resins with capture resins, it is said to avoid possible leaching of these proteinaceous resins, which cause immunogenic responses, into the biopharmaceutical drug product.
Johnson further said: “In essence, we are telescoping antibody DSP and conjugation, providing just one set of analytical development and release processes, whilst bringing in the use of much more cost-effective and safer resins.”
The firm has already launched a Specialist Process Innovation Group that will be responsible for the validation of the new method over the coming 18 months and any further technological innovations.