In Part I, we asked our experts to comment on emerging technologies. Digging a little deeper in Part II, the conversation shifts to problem-solving and process optimisation. In terms of scale-up and/or tech transfer, the question of the day is as follows: What specific challenges are you hoping to find solutions for at the event?
Carolina Egea, General Manager at Agarose Bead Technologies, states that one of the company’s main interests lies in the scale-up of highly specialised chromatography resins and ensuring that laboratory level performance can be translated to industrial scale.
We are keen to exchange insights on best practices in tech transfer between R&D and manufacturing, particularly when it comes to maintaining batch-to-batch consistency and complying with stringent regulatory requirements.
Additionally, we are very interested in learning how others are addressing supply chain resilience and cost-effective scalability in an increasingly demanding global market.
Matt Paterson, Chief Strategy Officer at Quotient Sciences, adds that, as a CDMO partner, we are increasingly able to support clients that are looking for US-based drug product manufacturing support.
The ongoing discussions and incentives to bring pharmaceutical manufacturing back onshore in the US have sparked more attention regarding the services available from our Philadelphia-based facilities.
More companies are exploring their options from US-based providers … and we’re well-positioned to assist clients by offering services from both our UK and US locations.
Nigel Stapleton, VP of Business Development and Head of Europe at Mabion, comments that moving from laboratory scale processes to cGMP manufacturing is one of the most critical and risk-prone stages in a programme’s lifecycle.
As Mabion provides end-to-end support from early clinical production to full commercial-scale manufacturing, we are experts in process development, optimisation and scale-up.
Our teams focus on reproducibility, process robustness and yield optimisation, ensuring that what works in the lab translates smoothly to large-scale production.
This includes tailored feeding strategies, advanced purification methods and predictive analytical controls to guarantee consistent product quality at every stage.
When it comes to tech transfer, Mabion offers clients a transparent and collaborative framework. We map out every detail of the process, from document review and gap analysis to on-site training and validation.
Our experience in transferring both biosimilars and innovative biologics between different scales and facilities allows us to anticipate challenges, mitigate risks and accelerate timelines.
Compliance is embedded at every stage, so our clients can feel confident that their products meet regulatory standards.
Michael Leuck, VP European Market, Hongene Biotech, acknowledges that scale-up in nucleic acid manufacturing presents unique challenges, particularly for large-patient siRNA medicines such as those targeting cardiometabolic diseases — where annual demand could reach tens of tons of API within a few years.
Conventional solid-phase synthesis was never designed for such volumes. At CPHI, we aim to engage with partners and technology providers regarding solutions to this scalability gap.
Earlier this year, he adds, Hongene advanced chemoenzymatic ligation into GMP manufacturing, providing a sustainable and cost-effective route for large-scale siRNA and guide RNA production.
Ongoing innovations in enzyme engineering, chromatography free purification and next-generation synthesis methods promise further improvements in yield, cost and quality.
Another key challenge lies in material and technology transfer, where misalignment between vendors or shipping constraints can cause costly delays.
To mitigate this, Hongene has invested in vertically integrated infrastructure to manage the entire nucleic acid drug supply chain under one roof, ensuring unified control of quality, logistics and cost.
At CPHI, we are seeking collaborations that strengthen these capabilities and enable our partners to advance seamlessly through the drug development lifecycle — from discovery to commercial scale — without compromising timelines, quality or compliance.
Scale-up and tech transfer in enzymatic manufacturing present unique challenges —particularly when reaching commercial scales.
At Codexis, says Britton Jimenez, SVP, Commercial Operations, we’re focused on understanding how enzymatic synthesis kinetics and impurity profiles shift during scale-up, and how to mitigate variability across batches and sites.
We’re also interested in best practices for transferring enzyme-enabled processes to CDMOs and GMP facilities, especially for RNA therapeutics, for which regulatory expectations are evolving rapidly.
Another key area is the integration of automation and digital tools to support tech transfer documentation, training and troubleshooting.
At CPHI, we’re looking to learn from peers and partners about how they’re addressing these challenges — whether through platform technologies, digital twins or collaborative models.
We’re also keen to explore how continuous manufacturing frameworks can simplify tech transfer and reduce timelines. These insights will help us refine our RNA manufacturing services.
Featured companies
- Companies:
- Codexis
- Mabion
- Hongene Biotech Corporation