Upscaling the complex processes for bioconjugates manufacturing is now a necessity in the pharma industry as demand surges for innovative therapies. Streamlining the development process for bioconjugates was discussed in a recent webinar by Dr Conor Barry, Piramal Pharmaceutical Solutions’ head of R&D for bioconjugates and large molecules. Piramal specialises in end-to-end services of monoclonal antibody production, peptide production, payload linkers and bioconjugate drug substance development and manufacturing.
Titled Integrated Strategies for Bioconjugate Development – From Conjugation Chemistry to Clinical Supply, the webinar was hosted by Selina Yue, senior analyst of healthcare oncology and haematology at GlobalData. The session began with market forecasts that emphasised the economic growth of the industry. GlobalData Healthcare revealed that only 11 ADCs generated any revenue in 2024. Yet by 2031, 45 ADCs are predicted to generate revenue. Furthermore, three new ADCs are projected to break into the top ten ADCs by sales revenue.
Managing complexities in the ADCs supply chain
In his presentation, Dr Barry first outlined the typical bioconjugation process flow. The stage of conjugation in payload linkers has seen more modern and novel conjugation technologies developed, which are often more site-specific. Multiple aspects must be taken into account during the planning process, as Dr Barry explained the pros and cons of enzymatic, engineered monoclonal antibodies (mAbs), and peptide-mediated conjugation.
Each of these forms of conjugation have its own unique supply chain model, which presents its own challenges and complications. Navigating these complexities early on ensures greater efficiency in the later stages of manufacturing. For Barry, it is a case of failing to prepare means preparing to fail. Design considerations for scaling, according to Barry, should also be maintained. For example, a reactor vessel may need to be replaced with a larger unit, while maintaining the same efficiency in the process.
In the webinar, Barry referenced a case study focused on the process of antibody-oligonucleotide conjugates that demonstrates the necessity for large-scale manufacturing of vital ingredients for drugs that often require lifelong prescriptions to treat genetic diseases such as muscular dystrophy and heart conditions. Scaling is a consideration that must be maintained, given the multiple moving parts in the supply chain. Ensuring an efficient supply chain is therefore central to any bioconjugation process.
Strategies for more efficient bioconjugation manufacturing
“[Early decisions in CMC] directly determine later speed, robustness, and transferability,” says Dr Barry. He advises treating CMC and manufacturability “not as an afterthought, but as something to really build into your lead identification stage”, as they can become strategic enablers. In a typical ADC supply chain, outlined by Barry, there can be as many as eight facilities and teams working simultaneously over a timeline – which requires coordination and management of the supply chain. “[Having] the right material of the right quality and quantity in the right place, and at the right time, can save a lot of difficulty as you go through the process,” adds Dr Barry.
A recurring theme throughout the webinar is that the bioconjugation strategy is just as important as the location. Dr Barry places an emphasis on project management, technical expertise and logistics across the supply chain. “[It is] an exercise not only in trying to manage the location and co-location of the materials,” Dr Barry says, but also in managing how the interfaces and teams that constitute the bioconjugation process play off each other.
In the growing and increasingly complex supply chains for bioconjugation, early integration of CMC is critical.
To watch the full webinar and learn more about creating efficiencies in the bioconjugation supply chain, with a live Q&A, register below.
