As the wheels of commerce churn and turn amidst the thronging aisles of CPHI Frankfurt, Manufacturing Chemist tracked down a select batch of onsite experts to discuss emerging technologies, pressing issues in terms of scale-up and tech transfer, and what topics we’ll be talking about in the months to follow
In part I of this series, we asked them to discuss which emerging technologies, such as AI, automation, digital twins and/or continuous manufacturing, they were currently exploring or investing in.
Innovation in manufacturing technology comes in many shapes and sizes, noted Nigel Stapleton, VP of Business Development and Head of Europe at Mabion.
Primarily, they need to focus on efficiency, quality and scalability. Single-use technology has become an industry standard in recent years for all except the largest scales … and that’s exactly because of its impact in these three key areas.
Mabion is currently focusing on two aspects of improvement. One is the development and manufacture of novel modalities such as bispecifics. These molecules are diverse and sometimes difficult to produce and analyse.
We pride ourselves on our ability to utilise tried and tested manufacturing and analytical platforms in bespoke ways to accommodate the varying needs of each molecule, all while keeping timelines and costs to a minimum.
A second area we are currently very active in is designing an optimal development pathway for the clinical development of biosimilars.
In light of the current regulatory debate about skipping Phase III clinical trials, we have designed a workflow that maintains a high degree of flexibility and efficiency but also meets the emerging requirements that allow clients to go straight from their Phase I clinical trials into PPQ.
We believe that this will open up the door to a new era of biosimilars, broadening patient access to these lifesaving medicines and reducing healthcare system costs globally.
To support these two development goals, we are exploring the potential of next-generation analytical methods such as real-time release testing, which can streamline product release while enhancing regulatory compliance.
At CPHI, we aim to identify practical, scalable solutions that balance innovation with compliance and operational feasibility.
Answering the same question, Michael Leuck, VP European Market, Hongene Biotech, commented: As a global leader in nucleic acid raw materials and CDMO services, Hongene is actively investing in technologies that directly enhance quality, scalability and sustainability.
Beyond automation and digital quality systems, which we are increasingly employing throughout our GMP sites, our strategic focus has been on the development of chemoenzymatic ligation technology.
This platform enables the scalable and cost-effective production of high-purity oligonucleotides by overcoming the inherent scale limitations of traditional solid-phase synthesis.
Critically, it positions us to meet the multi-ton demand expected from future cardiometabolic siRNA programmes while significantly reducing waste and improving environmental sustainability.
Hongene is also advancing protein engineering to optimise the enzymes that drive nucleic acid synthesis. Notably, we have developed proprietary thermostable T4 RNA ligase variants that function efficiently at elevated temperatures; this enhances both the precision and yield of chemoenzymatic ligation.
These innovations will play a pivotal role in terms of shaping the next generation of oligonucleotide manufacturing by combining scientific innovation with industrial scalability to deliver sustainable RNA therapeutics for patients worldwide.
Carolina Egea, General Manager at Agarose Bead Technologies, added: We are actively exploring the integration of automation and digitalisation in our manufacturing processes.
Automation is helping us increase reproducibility and efficiency in resin production, whereas advanced data analytics supports process optimisation and quality assurance.
We are also evaluating the potential of AI-driven process monitoring to predict performance trends and ensure consistency across production scales.
These technologies allow us to respond faster to customer needs and maintain the high standards required in biopharmaceutical purification.
At Codexis, Britton Jimenez, SVP, Commercial Operations, said that the company is actively investing in technologies that enable scalable, sustainable and precision-driven manufacturing for RNA therapeutics and small molecule APIs.
Leveraging enzyme engineering and process development to streamline RNA synthesis to generate high-quality nucleic acid therapeutics, our ECO Synthesis Manufacturing Platform is a prime example.
We’re also exploring automation and digital tools to enhance process control and reproducibility. AI/machine learning-driven enzyme optimisation is a growing area of interest, particularly when it comes to accelerating screening and predictive modelling.
We see strong potential in the use of digital twins to simulate biocatalytic workflows and tech transfer scenarios.
These technologies align with our mission to transform therapeutic manufacturing by increasing scalability, reducing complexity, improving efficiency and enabling greener processes.
At CPHI, we’re excited to share how these innovations are shaping our RNA manufacturing methods and small molecule API programmes … and to engage with partners who are similarly committed to advancing the future of pharmaceutical manufacturing.
In conclusion, Matt Paterson, Chief Strategy Officer at Quotient Sciences, stated that, recently, we’ve focused on improving our partnerships to streamline the development of new modalities.
Our collaboration with the UK technology innovation centre, CPI, is aimed at accelerating the development of RNA-based therapies by combining Quotient’s Translational Pharmaceutics platform with CPI’s expertise in the small-scale manufacture of RNA and LNP encapsulation to deliver a first-of-its-kind, integrated offering for the development of mRNA drug products.
Additionally, we are looking at how AI can be applied to advance drug product formulations and get them clinic-ready.
Read Part II here.
Featured companies
- Companies:
- Codexis
- Mabion
- Hongene Biotech Corporation