CDMO Europe

As biologics programs move closer to commercialization, timelines tighten and expectations for quality, regulatory readiness and scalability increase. Decisions made during development increasingly shape manufacturing performance, technology transfer and commercial readiness, making execution risk just as important as scientific progress.

Richter BioLogics supports the commercial production of therapeutic proteins, antibodies (including VHH/Nanobodies), bacterial vaccines and pDNA with a fully integrated development to-manufacturing model.

Backed by deep expertise in process and analytical validation and process performance qualification, the Germany-based contract development and manufacturing organization (CDMO) reduces execution risk, improves timeline predictability and supports seamless progression from start to finish.

“Our clients are involved with our manufacturing team from the beginning. There are no translation errors, here are no surprises,” says Thilo Kamphausen, Head of Business Development.

Richter BioLogics specializes in microbial process development, fermentation, purification, and GMP manufacturing. Process development, analytical strategy and manufacturing are aligned, ensuring every stage supports the next without disruption.

With nearly four decades of GMP manufacturing experience and recent investments in new GMP production lines, Richter BioLogics continues to strengthen its position as a trusted partner for biotechnology and pharmaceutical companies worldwide.

Building Integration from Day One

During a new microbial program, cross-functional teams engage simultaneously, whether developing a process from scratch or transferring an existing one for largescale manufacturing. Development scientists, analytical specialists and manufacturing teams work as a single project team from the outset, allowing decisions to be made with downstream manufacturing in mind. A dedicated project manager coordinates activities across departments, ensuring analytical strategies support process development milestones while maintaining a clear focus on GMP manufacturability.

This integrated approach reduces the risk of misalignment during technology transfer and manufacturing scale-up, creating continuity throughout development and production.

Connecting Fermentation and Purification

Microbial manufacturing demands precise coordination between upstream and downstream operations. Richter BioLogics has these activities designed as interconnected components of a unified manufacturing workflow.

It operates two independent multi-product GMP facilities, with upstream processing and downstream processing lines housed in separate suites. This decoupled setup provides clients with a high degree of process flexibility. Fermentation and purification activities are planned as an integrated workflow within a single project timeline to ensure seamless transitions between manufacturing stages.

During fermentation, upstream teams document harvest parameters in real time while downstream purification specialists engage during the final stages of cultivation to prepare for purifying the harvest.

This integration is supported by close collaboration across scientific, manufacturing and quality functions. The same cross-functional collaboration allows potential manufacturing issues to be addressed collectively before they become downstream execution risks. The company´s focused mid-sized structure enables direct communication and short decision-making pathways, allowing rapid responses to project needs while maintaining strict GMP compliance.

What gap in clinical trial technology led to development of specialized mobile infrastructure?

A medical organisation approached Inventus with what appeared to be a routine request to source and deploy mobile devices for a clinical trial.

The work itself was familiar. Co-Founder and CEO Steve Sanghera, and Co-Founder and Chairman Jim Michel had spent decades in telecommunications, managing mobile infrastructure across industries where systems are expected to perform reliably across geographies, networks and conditions. The assignment fell squarely within that experience.

They delivered what was required. But a medical company was not a typical buyer of that scale of mobile infrastructure. It made them wonder: why would a clinical trial depend so heavily on devices not designed for it?

Through conversations with trial sites, sponsors and operational teams, they learned that clinical trial devices were consumer-grade and were not built for regulated environments.

Inventus chose to address that gap by rebuilding the system. It replaced consumer hardware with purpose-built patient- and site-specific devices designed for clinical trials. These devices introduced a standardised, validated foundation, ensuring that interactions with the study adhered to defined parameters rather than varying across users and environments.

That decision established Inventus as the world’s first manufacturer dedicated exclusively to patient- and site-mobile technology for clinical trials, creating an entirely new category that did not previously exist.

But solving the device layer exposed a second set of challenges.
Once deployed into live trials, performance was no longer defined by the device alone. Data flow depended on connectivity across regions, and device behaviour depended on how it was controlled over time. These variables remained fragmented. Connectivity varied across networks. Control relied on adapting generic systems not designed for clinical protocols. Accountability sat across multiple vendors.

The model was extended beyond hardware to build an integrated infrastructure around the device.

Connectivity was redefined through Inventus Connect, the world’s first and only clinical data plan operator (CDPO). It ensured consistent, carrier-agnostic communication across geographies.

Control was established through Inventus Control, the only mobile device management (MDM) platform purpose-built for clinical trials, enabling devices to operate in alignment with protocol requirements throughout the lifecycle of a study.

“If you think about clinical trials as building a plane, sponsors and CROs design the engines and systems. We provide the rivets. Without those rivets, the plane doesn’t fly,” says Sanghera.

Building the Missing Infrastructure Behind Clinical Trials

How does integrated connectivity and device control improve consistency across global clinical trials?

Each device enters the trial already connected.

Provisioned with a global eSIM, it does not rely on a single carrier or require manual configuration as it moves across regions. Through Inventus Connect, devices remain connected across more than 150 countries, enabling eCOA data to be collected consistently and securely across borders. Connectivity adjusts in the background, allowing continuous communication regardless of location, while simplifying logistics and supporting reliable, cost-effective data management.

Staying connected is only the first layer. Subsequent layers determine how each device is governed.

Why is purpose-built mobile device management necessary for maintaining protocol alignment in studies?

Before deployment, each device is configured through the MDM layer to align with the protocol of the study. Across Windows, iOS and Android environments, Inventus Control enables the creation and deployment of protocol-aligned settings, approved applications and locked-down controls. What a participant sees and how they interact with the device are defined in advance, ensuring consistency across sites while protecting data integrity.

Device status, network connection and data transmission can be monitored in real time. If connectivity drops or behaviour shifts, the device can be accessed remotely and brought back into alignment. Software and application updates are deployed centrally, keeping devices in sync with study requirements without requiring physical intervention.

Transient protein expression (TGE) in mammalian cells has become a cornerstone of modern biotechnology, powering discovery and preclinical research worldwide. It enables the rapid production of proteins for screening, assay development, and candidate selection, but the process is often complex and unpredictable. Tedious steps, variability in yields, differences between constructs, and inconsistent results force teams to repeat attempts or troubleshoot, stretching timelines and consuming valuable resources. As protein targets become more complex, these challenges only intensify.

In an environment where delays in material quality or availability can impact downstream decisions, R&D teams need a system that consistently delivers, reduces complexity, contains costs, and accelerates programs.

Magellan Biologics and Consulting provides exactly that. With decades of experience in mammalian expression systems, the team has developed CHO 4Tx^®, a streamlined, ready-to-use platform designed to improve consistency, reduce rework, and increase yields. It gives R&D teams greater control over protein production so they can focus on science rather than setbacks.

“CHO 4Tx^® was designed to simplify TGE and eliminate variability-generating parameters. Researchers receive a straightforward protocol, high reproducibility, and support from a team that understands both the technology and the pressures our clients face,” says Jérôme Puginier, General Manager.

The Science Behind CHO 4Tx^®

Designed by scientists for scientists, CHO 4Tx^® simplifies TGE without compromising performance, offering fast setup, predictable output, and flexibility. The system combines three optimized components: a proprietary CHO cell line developed for high-yield expression, a patented three-step protocol, and three dedicated media formulations, each supporting a distinct phase of the process. The step in generating DNA delivery complexes prior to exposing the DNA to cells and media is eliminated.

The workflow is straightforward. After seeding cells in the cultivation medium, researchers switch to the transfection medium and add the DNA of interest. Three hours later, the production medium is introduced, supporting sustained expression for up to 14 days. No DNA complexing or feeding steps are required, reducing variability and hands-on time.

Europe’s biopharmaceutical sector continues to demonstrate steady progress as innovation, regulatory alignment, and investment converge to support advanced manufacturing capabilities. Within this evolving landscape, contract development and manufacturing organisations play a central role in enabling pharmaceutical companies to bring complex therapies to market efficiently. These organisations provide integrated services that range from early-stage development to large-scale commercial production, supporting a wide range of biologics, including monoclonal antibodies, vaccines, and cell-based therapies.

The growing reliance on external manufacturing partners reflects a strategic shift among pharmaceutical companies seeking to optimise resources and accelerate timelines. By leveraging specialised expertise and established infrastructure, organisations can reduce capital expenditure while maintaining focus on core research and commercialisation activities. This collaborative model has strengthened the position of European CDMOs as critical contributors to the broader life sciences ecosystem.

Evolving Infrastructure and Technological Capabilities

European CDMO manufacturing operates through ongoing investments in new facilities, which create advanced facilities that fulfil strict regulatory standards. The production facilities of today use manufacturing systems that can handle both small production runs and large production volumes to meet various client requirements. The industry is moving toward single-use technologies with modular facility designs, which help businesses run more efficiently while decreasing the time needed to switch from one production cycle to another.

Digital integration is changing manufacturing operations because data analytics, together with automation systems, help improve product consistency and product traceability throughout the manufacturing process. Biologics production needs these capabilities because their process control systems determine the quality of their final products. CDMOs are creating their operations according to quality management systems because they need to fulfil existing regulatory requirements that apply to multiple countries.

The transformation process needs workforce development to function effectively. The organisation needs skilled professionals who know how to handle bioprocess engineering tasks, quality assurance tasks and regulatory affairs tasks to maintain operational excellence. The European institutions help develop talent through special training programs, which guarantee the long-term viability of the industry.

"By leveraging specialised expertise and established infrastructure, organisations can reduce capital expenditure while maintaining focus on core research and commercialisation activities."

Partnership Models and Market Demand Partners

The demand for CDMO services in Europe arises from two factors, which include a strong biologic therapy pipeline and challenges encountered during drug development. Small biotechnology companies depend on outside partners who provide them with the necessary capabilities to operate their business without needing to spend large amounts of money. This dynamic has led to the creation of long-term partnerships that establish enduring ties between organisations through collaborative work toward common goals.

Pharmaceutical companies work with CDMOs to solve two problems, which involve their need to handle production capacity problems and their requirement to reduce their manufacturing process risks. The distribution of manufacturing across different partners helps businesses create stronger supply chains, which enable them to maintain operations during tough times. The method follows current industry patterns, which focus on creating adaptable systems while minimising potential risks.

CDMO pricing structures establish their pricing systems through three elements, which consist of process complexity, production volume requirements, and legal compliance obligations. Clients increasingly select their manufacturing partners based on two factors, which include cost efficiency and product reliability, together with technical capabilities. The shift demonstrates that organisations must uphold their quality standards while they need to fund ongoing improvement projects.

The European region provides strategic benefits because it offers standardised regulations together with existing market access advantages. The established approval procedures enable organisations to create products within anticipated timeframes for development and market entry. CDMOs establish research partnerships with innovation organisations through their strategic research centre locations, which enable them to achieve research centre proximity.

Strategic Considerations Shaping Future Growth

The biopharmaceutical CDMO manufacturing sector in Europe will expand based on its capacity to adjust to new medical treatments and shifting market demands. Advanced therapies that include gene and cell-based treatments need special manufacturing conditions, together with trained personnel. The companies that invest in these competencies will create superior market positioning, which allows them to draw various customer groups.

The importance of sustainability has increased because businesses need to follow environmentally responsible manufacturing methods. Organisations seek to lower their environmental effects through three methods, which include using energy-efficient equipment, minimising waste and sourcing materials in a sustainable manner. The company-wide efforts comply with regulatory standards and social expectations, which enable the organisation to sustain its operational functions over time.

The drive for capital resources, together with strategic investments, will determine how businesses pursue their growth plans. Organisations that want to expand their business operations need to make investments in technology, infrastructure, and workforce training, which stakeholders should evaluate for their potential to enable business expansion. The public and private sector partnerships will create better manufacturing systems throughout the entire region.

Digital technology integration is set to enhance business operations through advanced analytics, real-time monitoring, and predictive maintenance. These tools will improve operational efficiency and reduce uncertainties in production processes. Additionally, European CDMO manufacturing plays a crucial role in the global biopharmaceutical market, facilitating complex therapy development via technological advancements and strategic partnerships while adhering to regulatory compliance.

In modern medicine, the time elapsed between a laboratory discovery and a clinical-grade therapeutic is a critical measure of success. For complex biologics—such as monoclonal antibodies, therapeutic proteins, and novel vaccines—this journey has traditionally been long and arduous. A primary bottleneck has consistently been the very first step: producing enough of the candidate protein to perform basic functional tests. The creation of a stable, high-producing cell line is a precise but time-consuming art, often taking many months of selection and optimisation.

The widespread adoption and optimisation of transient expression systems mark Europe's biopharmaceutical ecosystem. Once relegated to small-scale academic research, these platforms have been supercharged to become industrial powerhouses, capable of collapsing protein production timelines from months to mere days. This acceleration is fundamentally changing how research is conducted, enabling a "speed to insight" that is fast-tracking the development of the next generation of medicines.

Deconstructing the Transient Workflow

The fundamental difference between transient and stable production lies in the handling of the genetic instructions. In traditional stable cell line development, the DNA (or gene) encoding the target protein is permanently integrated into the host cell's own genome. This creates a new, permanent "master cell bank" that will produce the protein indefinitely. However, the process of finding the rare cells that have correctly integrated the gene and delivering it at high levels can take three to six months, or longer.

Transient expression bypasses this entire integration process. Instead, a plasmid—a circular piece of DNA containing the gene of interest—is rapidly introduced into a high-density culture of host cells. This process, known as transfection, is akin to giving the cells a temporary set of instructions rather than rewriting their core operating manual.

The host cells of choice in the European biopharma sector are almost exclusively mammalian, primarily Human Embryonic Kidney (HEK) cells and Chinese Hamster Ovary (CHO) cells. The reason is critical: these cells possess the sophisticated internal machinery to perform human-like post-translational modifications. For a complex antibody or viral spike protein to function correctly in the human body, it must be folded into a precise 3D shape and decorated with specific sugar molecules (a process called glycosylation). Mammalian host cells execute these steps faithfully.

Once transfected, these cells become instant protein factories. They read the temporary plasmid instructions and begin synthesising and secreting the target protein at a rapid pace. Because the plasmid is not integrated, it is diluted with each cell division. The production run is therefore finite, or "transient," typically lasting from five to fourteen days. At the end of this short period, the protein is harvested from the culture medium. The result: researchers can move from a digital gene sequence to multiple grams of purified, functional protein in under two weeks.

Powering the Discovery Engine: High-Throughput Candidate Screening

The most profound impact of this speed is felt in the earliest "discovery" phase of drug development. Modern antibody discovery platforms rarely produce a single “magic bullet,” instead generating hundreds or even thousands of potential antibody candidates that bind to a disease target. The central challenge is to determine which of these candidates is the best: one that not only binds but also has the desired biological effect, and, just as importantly, is stable and "developable" enough to be manufactured as a drug.

This is where transient expression allows for the parallel production of these hundreds of variants. Researchers can generate milligram-to-gram quantities of 500 different antibody candidates simultaneously. Scientists no longer need to place bets on just a few candidates for a months-long stable line project. They can test the entire field and let the functional data—the "insight"—drive the selection of the most promising leads. This massive de-risking of the development pipeline is a key strategic advantage within Europe's research-intensive hubs.

Transient expression accelerates structural biology by enabling scientists to visualise the 3D atomic structures essential for understanding and rationally designing drugs. Techniques like X-ray crystallography and cryogenic electron microscopy (cryo-EM) allow researchers to create a precise atomic blueprint of a protein.

High-yield transient expression systems have solved this problem. Optimised protocols using high-density HEK or CHO cultures can now reliably generate the gram-scale quantities of complex proteins that structural biologists need. This "speed to structure" is revolutionary. A European academic lab can now design a new vaccine antigen, express it transiently, and determine its 3D structure, all within a single month.

This speed unlocks an iterative design cycle. Scientists can observe the structure, identify a flaw, digitally re-engineer the protein to enhance its stability or potency, and then use the transient system to produce the new version for immediate structural analysis. This rapid feedback loop between rational design and empirical data is the engine of modern vaccine and biologic engineering.

Europe's Biopharma Ecosystem Primed for Agility

The continent is characterised by a dense, highly collaborative network of world-class universities, agile small- and medium-sized biotech enterprises (SMEs), specialised contract research organisations (CROs), and established large pharmaceutical organisations.

Transient expression is the flexible "glue" that facilitates rapid movement of projects through this ecosystem.

This agility allows the European sector to pivot quickly, respond to new public health threats, and efficiently feed the rich pipelines of innovative biologics and vaccines for which the region is known. Regulatory authorities in Europe have encouraged this fast-track development by emphasising robust data packages. Transient expression delivers this data—functional, structural, and developability—earlier and more comprehensively than ever before.

Transient expression has evolved far beyond its origins as a simple research tool. It is now a fully-industrialised, high-yield, and indispensable strategic platform. By collapsing protein production timelines from months to days, it provides the essential "speed to insight" that fuels the two most critical activities in early-stage development: high-throughput screening and rational structural design. For the innovative and highly-networked European biopharma industry, this technology is not just an accelerator; it is a foundational enabler, clearing the path for the next wave of life-saving medicines.

Stephan Sheehan, director of external development at Alkermes, has built a career defined by innovation, adaptability and a relentless drive for excellence. With a Chemical Engineering degree from University College Dublin, he began his journey at Intel, where he mastered Six Sigma, root cause analysis and statistical process control. Sheehan then transitioned to Millipore, where he spearheaded the transfer of seven medical device production lines and optimised modelled membrane manufacturing processes, earning a Six Sigma Greenbelt. Since joining Alkermes in 2014, Sheehan has driven transformative change in pharmaceutical manufacturing. From pioneering the development of complex drug delivery candidates to managing CDMO partnerships for both small—and large-molecule projects, he has been instrumental in shaping Alkermes strategy and operations. His ability to navigate complex challenges and drive results positions him as a key figure in pharmaceutical innovation, shaping the future of the industry.

Recognising Sheehan’s visionary leadership and corporate fineness that has driven business success, this exclusive interview delves into his invaluable insights on transforming CDMO relationships from operational partnerships into strategic collaborations.

At a Glance:

• A tailored governance framework ensures each partnership aligns with evolving needs, fostering strategic collaboration and operational success.

• Root cause analysis and structured thinking drive effective resolutions without rigid reliance on formal frameworks.

• Weekly technical meetings focus on process development, while biweekly business meetings streamline financials and contracts, enhancing outcomes.

A Strategic Shift: Enhancing CDMO Performance

When I first started managing CDMOs, one of our biggest hurdles was working with a large molecule drug substance manufacturer. We faced communication breakdowns and inconsistencies in managing both the drug substance and drug product CDMOs for the same product. The absence of a standardised governance model only amplified these challenges.

“The key to effective problem-solving isn’t rigid frameworks—it’s disciplined, analytical thinking that uncovers root causes and drives actionable solutions”

Realising the need for a more strategic approach, we set out to develop a comprehensive governance framework. Our goal was to create a structure that would align business objectives with a clear, executable programme plan for our CDMOs. By focusing on building a best-in-class partnership—both strategic and operational—we aimed to streamline interactions and enhance efficiency. Nearly two years after implementing this model, it has become the cornerstone of our stronger, more effective CDMO collaborations.

The Three-Tier Approach

Our governance model elevates CDMO relationships from simple operational partnerships to strategic collaborations that drive lasting value. By aligning business, strategic and operational goals, we’ve created a three-tier model that guarantees seamless integration and mutual success.

At the top tier, ‘Business Direction,’ we define the strategic objectives for both Alkermes and the CDMO. Annual meetings help us align priorities, assess the CDMO’s evolving capabilities and identify new opportunities for growth. This ensures that as they continue to deliver high-quality results, we can explore new avenues for collaboration.

The middle tier, ‘Executional Oversight,’ turns these strategic objectives into actionable tactical plans, maintaining accountability throughout the execution process.

At the bottom tier, ‘Operational Delivery,’ the focus is on executing those tactical plans, ensuring every level of the partnership is aligned to deliver measurable, impactful results. This governance structure empowers both Alkermes and our CDMOs to work as true strategic partners, creating a future of collaboration, innovation and shared success.

The Governance Model Boosting CDMO Success

At the operational delivery level, we use a governance framework that is applied across all our CDMOs. However, each partnership is unique, so we tailor the operating model to meet the specific needs of the relationship. This model evolves based on lessons learned and the changing dynamics of the partnership.

One critical improvement we made was separating technical and business discussions. Initially, we combined these in technical meetings, which proved ineffective. Now, we hold weekly technical meetings focused solely on analytical development, process development, formulation and similar areas. Non-technical topics, such as contract reviews, invoice resolution, financials, team dynamics and risk mitigation, are addressed in biweekly business meetings. This separation makes sure technical teams can concentrate on their work without distractions, while business issues are handled efficiently. This dual-meeting structure has significantly improved technical and business outcomes, fostering stronger and more effective partnerships.

The Mindset of Analytical Problem-Solving

Six Sigma’s core principles of root cause analysis and analytical problem-solving remain central to my approach. For me, it’s less about adhering to a specific framework and more about embracing a disciplined mindset.

When tackling challenges, I prioritise a methodical, structured approach—breaking down problems to uncover root causes and devise effective solutions. This requires setting aside emotions and relationship dynamics to remain objective and focused on achieving the best outcome. Although I may not use Six Sigma tools directly, the analytical rigour it fosters continues to shape how I navigate and resolve complex issues.

Ask, Learn, Adapt: Strategies for Succeeding in a New Role

Transitioning from a technical field like process development to managing relationships and working with vendors can be a steep learning curve. One of the most valuable strategies is to ask questions and stay curious. I leaned heavily on colleagues with years of experience, setting up weekly meetings to discuss best practices and gain their insights.

Attending conferences and networking with peers also proved helpful in understanding industry standards and common challenges. It’s important to remember that most issues you encounter have likely been addressed before, so there’s no need to reinvent the wheel. However, while industry best practices are a great resource, they shouldn’t be copied and pasted directly into your organisation.

Instead, take the time to adapt them to the unique context of your situation to make them work effectively. By being curious, collaborative and adaptable, you can navigate the challenges of a new role with confidence.

Roswitha is a seasoned General Counsel with 20 years of experience in the life sciences industry. After specialising in intellectual property law within private practice, she transitioned to legal and compliance roles at pharmaceutical giants like Eli Lilly and Company. Currently the Head of Legal, Compliance, ESG and Risk Management at Kyowa Kirin, Roswitha thrives at the intersection of law, business and sustainability. Her expertise spans building high-performing teams, fostering cross-functional collaboration and embedding robust compliance programs. Roswitha’s passion lies in leveraging innovation and technology to protect corporate interests while driving sustainable growth. Holding a Harvard-Business-School accelerated degree, focussed on management, leadership, change, and innovation. In her current role as SVP General Counsel & Chief Compliance Officer, she acts as a strategic advisor and partner to the CEO and President, as well as the Executive Team, and she also leads an experienced legal team of attorneys and compliance professionals.

Through this interview, Reisinger discusses the key challenges, technological advancements and proactive strategies required for legal and compliance professionals to navigate the rapidly evolving life sciences landscape while enabling responsible innovation that improves patient outcomes and drives sustainable growth.

What Challenges Have You Witnessed In The Life Sciences Sector, And How Have They Impacted The Field?

The life sciences industry faces mounting pricing pressures–a pervasive challenge. A key hurdle for companies focusing on rare diseases is ensuring patients receive proper treatment promptly. This is an area where emerging technologies could provide immense value by accelerating patient identification and access to appropriate therapies.

Rapid tech advancements significantly impact the industry. Artificial intelligence (AI) is a prime example, and it is rife with potential benefits if deployed responsibly and ethically. But, legislation often lags behind the pace of technological innovation, presenting regulatory challenges.

Geopolitical risks have unfortunately escalated over the past decade, adding complexity to an already intricate global landscape. Environmental, Social and Governance (ESG) principles, particularly climate change initiatives, have emerged as a prominent trend influencing business strategies and legal/compliance functions.

These multifaceted issues–patient access, technological disruption, geopolitical tensions and ESG’s rise - represent some of the defining trends and tests confronting the life sciences sector and legal professionals operating within it. Navigating them adeptly requires foresight, cross-functional collaboration, and a keen understanding of their intersections and implications.

Are there any innovative advancements transforming the healthcare business regarding legal and compliance management?

A key transformation catalysing the life sciences industry lies in leveraging technology effectively. This also extends to the legal profession, although lawyers tend to be more conservative by nature. The life sciences field is among the most heavily regulated industries, cultivating a generally risk-averse mindset.

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Emerging trends are influencing and reshaping legal practices. Technology, particularly artificial intelligence (AI), presents significant opportunities. Contract management automation through AI is an area garnering attention as the capabilities of AI tools rapidly evolve from what was available just three years ago.