At another of this year’s CPHI Frankfurt 2025 roundtable, executives from Mabion, Quotient Sciences and Ofichem shared how digital transformation, evolving regulation, and sustainability are redefining contract development and manufacturing.

From AI-driven analytics to platform-based solutions and ESG-focused operations, the companies outlined how they are adapting to new expectations from clients and regulators. The discussion highlighted the growing importance of automation, data integrity, and environmental responsibility in shaping the next generation of biopharmaceutical partnerships.

Anna Czubatka-Bieńkowska, Project Management Division Manager in Mabion Biologics CDMO

Which emerging technologies (e.g., AI, automation, digital twins, continuous manufacturing) are you currently exploring or investing in?

At Mabion, , we look at emerging technologies primarily through how they support project execution and accelerate value delivery to our clients. We are focusing on automation in both upstream and downstream processes to increase reproducibility and minimize variability, as well as in analytics to shorten turnaround times. At the same time, we are building platform-based solutions that allow us to standardize certain steps, early warning about the risks, and give clients faster and more predictable timelines. From a project management perspective, these technologies are not only enablers of scientific progress but also tools to improve planning accuracy, resource allocation, and overall efficiency.

How is data analytics changing the way you make decisions in R&D and commercialization?

Data analytics has become a key decision-making tool across our projects. By integrating real-time bioprocess monitoring data with advanced analytics we are able to detect issues earlier, perform faster root-cause analysis, and implement predictive quality management. In R&D, this allows us to quickly identify the most promising directions and optimize conditions without unnecessary iteration. In commercialization, analytics guide tech transfer and scale-up activities, providing us with a fact-based way to manage risks and timelines.  This makes our projects more efficient, predictable, and transparent for our partners.

What regulatory changes (in key markets like the EU, US, or Asia) are having the most significant impact on your operations?

Regulatory change is one of the factors that has the strongest impact on how we plan and manage projects. The most significant shift we see is in biosimilar regulatory pathways, with agencies such as FDA and EMA increasingly moving away from mandatory large Phase III clinical efficacy studies when analytical and functional evidence is sufficient. The recent FDA waiver of clinical efficacy studies for a monoclonal antibody biosimilar is a game changer, it has the potential to cut costs and timelines dramatically. EMA’s draft reflection paper is also moving in this direction, calling for case-by-case approaches.

For Mabion, this shift means our projects place even more emphasis on advanced analytics, comparability, and regulatory strategy. We are investing in capabilities that allow us to deliver strong CMC packages, functional assays, and data sets that can support streamlined approval pathways. From a project perspective, this influences how we scope, structure, and prioritize activities, ensuring that resources are aligned with the evolving expectations of regulators.

Another trend is the growing harmonization between agencies in different regions. This helps us design global development strategies that reduce redundant work and shorten time to market entry across multiple jurisdictions. For smaller biotech clients, navigating this regulatory complexity can be a real challenge, and this is where our role as a CDMO is particularly valuable. Beyond execution, we provide guidance, risk assessments, and structured regulatory project planning, helping partners reduce uncertainty and keep their development on track.

How are ESG goals shaping your manufacturing and procurement strategies?

In response to the most important contemporary market and regulatory challenges, and in order to meet the expectations of its stakeholders, the Company has incorporated ESG factors into its strategic management. In connection with the above, on 19 January 2024, the ESG Strategy for 2024-2027 was adopted, with selected objectives revised. The updated ESG Strategy for 2025-2027 was adopted on 23 April 2025. The ESG Strategy was developed in a process involving employees, experts and stakeholders from the company’s environment. Thanks to the analysis of business objectives and trends, the legal environment, the identification of areas of influence, and the analysis and mapping of stakeholders, the Strategy was divided into three pillars: environmental, social and corporate governance.

Within these pillars, we defined eight strategic objectives, twenty-three operational goals, and detailed KPIs. In production, ESG priorities drive more efficient resource management and reduction of greenhouse gas emissions, while in procurement they guide supplier selection and collaboration. We also include Scope III carbon footprint assessments across our supply chain. We prioritise working with suppliers who demonstrate strong environmental and ethical standards, ensuring that our production and sourcing reflect the same values expected by our clients. This integration of ESG into operations supports compliance, reduces risks, and strengthens long-term competitiveness.

Do you see sustainability as a competitive advantage in securing contracts and partnerships?

Yes, sustainability is increasingly a competitive advantage in securing contracts and partnerships, and at Mabion we see it clearly in our daily interactions with clients. More and more, pharmaceutical and biotech companies are under pressure to demonstrate progress toward ambitious ESG commitments, and they expect their CDMO partners to actively contribute. Our partners want assurance that their supply chains are resilient, ethically managed, and aligned with global climate goals. For us, sustainability is not just about compliance, it is about building trust, reducing risks, and creating long-term value.

What steps are you taking to reduce your environmental impact while maintaining product quality?

We place strong emphasis on minimising our environmental impact while ensuring product quality. All processes are managed in full compliance with current environmental regulations and standards, supported by our Integrated Management System (IMS), certified to ISO 14001, ISO 45001, and ISO 50001. This framework, together with our Environmental Policy, allows us to go beyond compliance by driving initiatives that reduce resource consumption and protect the environment.

We monitor and analyse our environmental footprint with precision and undergo regular internal and external audits to identify risks and improvement areas. In parallel, we implement projects focused on efficient management of water and energy, testing and deploying solutions that optimise resource use without compromising product quality. Our approach ensures that sustainability targets are embedded into daily operations, making environmental responsibility an integral part of project execution and long-term growth.

Thierry Van Nieuwenhove, Chief Executive Officer, Quotient Sciences

 Which emerging technologies (e.g., AI, automation, digital twins, continuous manufacturing) are you currently exploring or investing in?

In 2025 we have focused on advancing our collaborations with partner companies to streamline the path of early development for novel modalities. Our collaboration with UK technology innovation centre, CPI, is aimed at accelerating the development of RNA-based therapies, combining  Quotient Sciences’ Translational Pharmaceutics® platform with CPI’s expertise in small scale manufacture of RNA and LNP encapsulation to deliver a first-of-its-kind, integrated offering for the development of mRNA drug product.

Additionally, we are looking at how AI can be applied to advance drug product formulations, getting them clinic-ready.  We have an active AI initiative and will be making formal announcements on a collaboration later this year.

What regulatory changes (in key markets like the EU, US, or Asia) are having the most significant impact on your operations?

Recent FDA draft guidance proposing updates regarding animal testing and circumstances where it may not be required, places greater responsibility on developers to identify innovative alternatives. With our Translational Pharmaceutics® platform, we enable the development and testing of formulations based on human data, facilitating more efficient progression of molecules through the development process.

Also, the ongoing discussions and incentives to bring pharmaceutical manufacturing back onshore in the US has sparked more attention in services available from our Philadelphia-based facilities. Our facilities in Philadelphia have been part of Quotient Sciences’ sites for nearly 10 years. 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.

How are ESG goals shaping your manufacturing and procurement strategies?

Our goals for ESG are deeply embedded in our operational strategy. At our facilities in 2024, we implemented energy-saving initiatives, such as LED lighting upgrades and optimizing lab equipment usage. We also piloted the My Green Lab Ambassador Program, empowering scientists to lead sustainability efforts from within the labs. These grassroots initiatives are helping us rethink single-use plastics and embed environmental stewardship into daily operations.

Procurement is another key area of focus. We made a shift to fully incorporating emissions from Purchased Goods & Services into our Scope 3 reporting, and are improving supplier engagement to ensure our partners align with our sustainability values. Integrating ESG criteria into supplier selection and evaluation lets us drive sustainability across our entire value chain.

Do you see sustainability as a competitive advantage in securing contracts and partnerships?

Absolutely. Sustainability is no longer a “nice to have” but something that our clients expect. Our commitment to Scope 3 emissions reporting and adopting renewable energy, for example, are steps we are taking as a forward-thinking, responsible partner. Being a signatory to the UN Global Compact, which we committed to earlier in 2025, reinforces our alignment with global sustainability standards.

What steps are you taking to reduce your environmental impact while maintaining product quality?

There are no compromises for product quality in a highly regulated industry like ours. Our goal is to not have sustainability enhancements compromise product safety or efficacy, but present opportunities to improve our processes and reinforce our commitment to quality.

Our ESG efforts have looked at energy efficiency, waste reduction, and water conservation at our facilities. For example, through the My Green Lab pilot program that we recently completed at our Nottingham site, we looked to introduce reusable HDPE powder scoops instead of single-use polypropylene weigh boats that were previously being used as scoops for raw materials. Additionally, we assessed some of our equipment and made decisions to place them on timers for more effective energy use. Any changes were matched with risk assessments and quality control testing to ensure continued compliance with good laboratory practices and manufacturing (GLP/GMP) standards.

Marinus Bouma, Business Development, Ofichem

Which emerging technologies (e.g., AI, automation, digital twins, continuous manufacturing) are you currently exploring or investing in?

Ofichem is investing in innovative technologies through M&A, and has recently acquired the innovative companies Avivia and Meribel Pharma Solutions Uppsala. The companies are focusing respectively on formulation development, analytical method design, dissolution testing, and excipient characterisation, antibody-drug conjugates (ADCs), oligonucleotides, and proteolysis-targeting chimeras (PROTACs) – three fast-growing, high-potential areas shaping the next generation of therapeutics. Together, these acquisitions are building blocks in Ofichem’s long-term transformation. They bring Ofichem closer to a model where science leads the way, innovation drives growth, and Ofichem teams work side by side with customers to solve the industry’s most complex challenges.

In addition, our drug substance business is exploring continuous manufacturing for the resource effective, green, and sustainable production of APIs in the IPSEI project.

How is data analytics changing the way you make decisions in R&D and commercialization?

Ofichem has teams with QYOBO a data analytics AI company to drive business growth. Ofichem has initiated an IT improvement program to enhance transparency and automation in data analytics.