Industry leaders discuss the critical transition from laboratory to industrial scale, sharing insights on maintaining product consistency, regulatory compliance and supply chain resilience in a demanding global landscape.
With contributions from Agarose Bead Technologies, Quotient Sciences, Mabion, Hongene Biotech, and Codexis, the article highlights the challenges and solutions involved in process optimisation, technology transfer and the adoption of digital and sustainable manufacturing methods.
These discussions set the stage for the final part, where further innovations and future directions will be explored.
Discussing the major talking points at this year’s CPHI Frankfurt, Britton Jimenez, SVP, Commercial Operations at Codexis, expects the event to spotlight several transformative trends.
Chief among them are scalable and continuous manufacturing, sustainability and advanced analytics. Continuous manufacturing is gaining traction in various modalities, offering improved efficiency and quality control.
For RNA therapeutics, it’s especially relevant as companies seek scalable solutions beyond solid-phase oligonucleotide synthesis (SPOS). Sustainability will also be front and centre, with enzymatic approaches such as Codexis’ ECO Synthesis Manufacturing Platform offering greener alternatives to legacy methods.
We anticipate strong interest in how enzyme-enabled processes reduce solvent use, improve quality and decrease hazardous waste.
Advanced analytics — including AI-driven/machine learning modelling and real-time monitoring — are reshaping process development and tech transfer … and we’re eager to see how these tools are being applied across the industry.
Finally, regulatory innovation and digitalisation will likely be key themes, as companies navigate complex compliance landscapes and embrace smarter manufacturing.
At Codexis, we’re proud to contribute to these conversations and showcase how our enzymatic synthesis technologies enable scalable, sustainable and high-impact solutions for RNA and small molecule manufacturing.
Carolina Egea, General Manager at Agarose Bead Technologies, believes that sustainability and greener manufacturing practices will continue to be key themes as our industry seeks to reduce environmental impact without compromising quality.
Another area that will be very prominent is continuous manufacturing and process intensification, which both offer clear advantages in terms of efficiency and flexibility.
Finally, the growing role of advanced analytics and digital tools to support regulatory compliance, quality control and faster product development will certainly be discussed.
These trends are highly relevant to companies such as ours as they shape the future of bioprocessing and downstream purification.
Nigel Stapleton, VP of Business Development and Head of Europe, Mabion, suggests that a major focus in the industry is on drug substance manufacturing and the ability to reliably scale from clinical to commercial — all while maintaining challenging timelines and meeting regulatory standards.
Mabion’s state-of-the-art facilities deliver consistent, high-quality production across biosimilars, originators, vaccine antigens and complex proteins such as bispecifics.
Our track record of on-time delivery speaks for itself and is driven by our broad analytical platform.
State-of-the-art and in-depth analytics are vital to a CDMO’s success. This allows our scientists to gain deep process understanding during USP/DSP development, monitor processes in real-time and react nimbly to any development as it occurs.
Having our analytical labs under the same roof as our production bioreactors means that samples can be taken and analysed without any delay … and decisions can be made in a fully informed and data-driven way. This ensures the on-time release of products and a reliable service to our clients.
The demand for robust drug characterisation and quality control continues to grow as regulators place increasing emphasis on CQAs and comparability. Mabion provides full analytical method development, optimisation, validation and GMP release testing.
Our capabilities span potency assays, impurity profiling, stability studies and biosimilarity assessments.
By integrating analytics with manufacturing and process development, we ensure that CQAs are monitored at every stage of production, supporting faster release and reduced risk.
This data-driven, science-based oversight will resonate strongly with developers seeking assurance in regulatory submissions and global market access.
With the company’s focus on the nucleic acids space, Michael Leuck, VP European Market, Hongene Biotech, provides the final word. We expect our CPHI discussions to centre on scalability, sustainability and supply chain resilience.
siRNA and mRNA are expanding rapidly into large-patient indications, which will test the industry’s ability to produce multi-ton volumes of API. Sustainability will likewise remain a key theme as regulators and partners intensify demands for greener chemistries and reduced waste.
Hongene is directly addressing these pressures through its chemoenzymatic ligation platform, which delivers higher yields, lower waste and scalable GMP production of siRNA, supporting future cardiometabolic and other large-volume disease programmes.
In parallel, our vertically integrated supply chain provides end-to-end visibility and exquisite control of quality, timelines and cost.
We also anticipate growing interest in advanced analytics, AI and digitalisation. Investment in these tools is critical to ensure quality, reproducibility and compliance as manufacturing complexity increases.
Hongene is actively advancing digital quality systems and evaluating continuous manufacturing to further enhance product quality, consistency and efficiency.
In short, the nucleic acid industry’s most pressing challenges — scalability, sustainability and resilient supply — are exactly where Hongene is investing to create lasting value for its partners and for patients worldwide.