Why Small CDMOs Matter in Pharma

Valsynthese is a Contract Development and Manufacturing Organization (CDMO) based in Brig, Switzerland, that provides high-quality services to its worldwide network.

Since its founding in 1983, the company has evolved into a premium provider of development and production services and a specialist in handling hazardous chemical reactions. Its approach involves its customers throughout the process, from development to scale-up, in constant cooperation. Beginning with tailor made and accurate propositions for specific projects, Valsynthese applies a custom-fit project management approach for every customer.

In this conversation with Contract Pharma, Dr. Max Lauwiner, CEO of Valsynthese, highlights the organization’s agility and emphasizes how the CDMO’s small size enables close, transparent and technically driven collaboration. He also addresses broader industry themes such as navigating geopolitical, logistical and quality risks.

Contract Pharma: What advantages do small CDMOs offer compared to larger, global organizations when supporting early-stage or innovative programs?

Max Lauwiner: Small CDMOs can offer a level of agility, proximity and senior technical attention that is particularly valuable for early-stage or innovative programs. At this stage, projects often evolve quickly: the process may not yet be fully defined, analytical methods may still be under development, and timelines can change depending on clinical, regulatory or financing milestones. A smaller CDMO is often able to adapt faster, allocate experienced experts directly to the project, and make decisions without excessive organizational complexity.

For clients, this means shorter communication lines, faster technical feedback and a more collaborative way of working. Small CDMOs are also well suited to handling complex or non-standard chemistry, where flexibility, problem-solving and hands-on experience are critical. Rather than applying a rigid platform approach, they can tailor the development path to the molecule, the client’s priorities and the intended next development milestone.

CP: Flexibility is often cited as a key strength of smaller CDMOs. What does flexibility mean in practice for your organization and your clients?

Lauwiner: For us, flexibility means the ability to respond quickly and pragmatically to changing project needs while maintaining quality, safety and regulatory discipline. In practice, this can involve adapting production schedules, modifying batch sizes, accelerating analytical work, or adjusting the development plan when new technical information becomes available. Early-stage projects rarely follow a perfectly linear path, so flexibility is about helping clients move forward despite uncertainty.

It also means direct access to decision-makers and technical experts. Clients do not need to navigate multiple layers of organization to get answers or resolve issues. This is especially important for biotech companies, where internal teams are often small and timelines are strongly linked to financing rounds, toxicology studies or clinical trial starts. Flexibility is not improvisation; it is structured responsiveness. The goal is to remain adaptable while ensuring that every decision is technically justified, well documented and aligned with the client’s long-term development objectives.

CP: How do small CDMOs contribute to securing pharmaceutical supply chains, particularly in a period of increased global disruption?

Lauwiner: Small CDMOs play an important role in strengthening pharmaceutical supply chains by offering regional, specialized and responsive manufacturing capacity. Recent global disruptions have shown that overreliance on distant or highly concentrated supply chains can create significant risks. European-based CDMOs, for example, can provide clients with greater supply chain transparency, shorter logistics routes and closer operational control.

Smaller CDMOs also contribute by supporting dual sourcing strategies, producing critical intermediates or APIs, and offering backup capacity for complex chemistry. Their ability to react quickly can be valuable when clients need to qualify an alternative supplier, transfer a process, or respond to sudden changes in demand. In addition, smaller organizations often have deep expertise in specific technologies or chemistries that may not be widely available. By combining technical specialization with proximity and responsiveness, small CDMOs help create more resilient, diversified and secure pharmaceutical supply networks.

CP: How do you approach technical collaboration with clients, especially emerging biotech companies that may have limited in-house development resources?

Lauwiner: Our approach is based on close, transparent and technically driven collaboration. Many emerging biotech companies have strong scientific ideas and promising molecules, but they may not yet have extensive internal process development, scale-up or manufacturing resources. In these cases, the CDMO must act not only as a service provider, but also as a technical partner.

We typically begin by understanding the molecule, the development stage, the available data, the target timeline and the client’s key risks. From there, we work together to define a realistic development and manufacturing strategy. This may include route assessment, process optimization, analytical method development, impurity control, safety evaluation and scale-up planning. Regular technical exchanges are essential, as they allow decisions to be made quickly and based on data. For smaller biotech clients, this collaborative model can reduce complexity, accelerate progress and provide access to experienced chemical development and manufacturing expertise without the need to build all capabilities internally.

CP: How early in the development process do you typically engage with clients, and how does this early involvement impact outcomes?

Lauwiner: The timing of our engagement can vary significantly depending on the client’s situation and the maturity of the product.

In many cases, we become involved during the clinical development phase, often when only a laboratory route and limited analytical data are available. In these situations, early CDMO involvement can create significant value. We can review the process from a scalability, safety, quality and regulatory perspective, identify potential risks such as hazardous steps, difficult purifications, unstable intermediates, impurity issues or raw material constraints, and help design a development path that supports the client’s next milestone — for example clinical trial material, later validation planning or commercial readiness.

In other cases, clients approach us with products that are already commercialized. The driver may be the need for an additional manufacturing source, supply chain diversification, improved resilience or a more competitive production setup. In such cases, the focus is different: we need to rapidly familiarize ourselves with the existing process, transfer and adapt it to our equipment, scale it up where needed, and establish robust production at the required quality, cost and regulatory standard.

So, whether we are involved during clinical development or with an already commercial product, our role is to help the client reach the next objective efficiently – with a process that is safe, robust, scalable, compliant and economically competitive.

CP: How do you ensure that innovation is maintained while also meeting regulatory and quality expectations?

Lauwiner: Innovation and quality should not be seen as opposing forces. In pharmaceutical development, true innovation must be translated into processes that are reproducible, safe, well controlled and compliant. Our role is to help clients develop innovative chemistry in a way that can meet regulatory expectations as the product advances.

This starts with a strong scientific understanding of the process. We focus on identifying critical process parameters, impurity profiles, raw material risks, analytical requirements and safety aspects early in development. At the same time, we apply an appropriate level of documentation and quality oversight depending on the project phase. For early-stage programs, the approach must remain efficient and proportionate, while still building a solid foundation for later GMP development. Cross-functional collaboration between R&D, production, engineering, quality assurance, quality control and regulatory experts is essential. This ensures that innovation remains practical, scalable and compatible with the expectations of pharmaceutical development.

CP: How do you approach scaling projects from lab to pilot to commercial production?

Lauwiner: Scale-up is a stepwise process that requires both scientific understanding and practical manufacturing experience. We start by evaluating the laboratory process in detail, including reaction kinetics, heat release, mixing, mass transfer, impurity formation, isolation, drying and waste streams. The objective is to understand not only whether the chemistry works, but how it behaves under conditions relevant to larger scale production.

Before moving to pilot scale, we aim to identify the main technical and safety risks and define suitable control strategies. Pilot production then serves as a critical bridge between laboratory development and commercial manufacturing. It allows us to confirm process robustness, generate representative material, refine analytical methods and collect data for further development. For commercial production, the focus shifts to reproducibility, cost efficiency, supply chain reliability, GMP compliance and long-term process control. A successful scale-up is not simply a larger batch; it is a controlled transition from scientific concept to reliable industrial process.

CP: How would you describe your approach to building long-term partnerships with clients?

Lauwiner: Long-term partnerships are built on trust, transparency and consistent technical performance. For us, a partnership begins with understanding the client’s molecule, but also their broader development strategy, business constraints and decision-making timelines. This allows us to provide support that is technically sound and aligned with the client’s real priorities.

We believe that open communication is essential, especially when challenges arise. In complex chemical development, not every experiment or scale-up step will proceed exactly as planned. What matters is how quickly issues are identified, communicated and resolved. Clients value a partner who is proactive, honest and solution-oriented.

Over time, long-term relationships also create efficiency: teams understand each other’s expectations, processes are transferred more smoothly, and future projects can start faster. Our objective is not only to deliver individual batches, but to become a reliable development and manufacturing partner across multiple phases of the product lifecycle.

CP: What trends do you see shaping the future role of small-sized CDMOs over the next 5-10 years?

Lauwiner: Over the next 5-10 years, small-sized CDMOs will play an increasingly important role in specialized, flexible and resilient pharmaceutical manufacturing. One major trend is the continued growth of biotech innovation, including highly complex molecules and niche indications. Many of these programs require tailored development support rather than standardized large-scale manufacturing platforms.

Another important trend is supply chain diversification. Pharmaceutical companies are looking for reliable regional partners, especially in Europe and North America, to reduce geopolitical, logistical and quality risks. Small CDMOs with strong technical expertise can benefit from this shift. We also expect increasing demand for sustainable chemistry, improved process efficiency, better use of digital tools and more integrated development services. Small CDMOs that combine scientific depth, GMP capability, responsiveness and customer intimacy will remain highly relevant. Their future role will not be to compete only on size, but to provide specialized expertise and partnership models that larger organizations may find difficult to replicate.

CP: How is Valsynthese evolving its capabilities to continue supporting innovation pipelines?

Lauwiner: Valsynthese is continuously developing its capabilities to support clients from early development through scale-up and commercial manufacturing. Our focus is on strengthening the link between chemical development, pilot production and industrial-scale GMP manufacturing. This is particularly important for innovative pharmaceutical programs, where processes often require adaptation, optimization and careful technical guidance before they become robust enough for larger-scale production.

We are investing in targeted improvements to our production assets, technical infrastructure and project execution capabilities. This includes enhancing flexibility in batch sizes, supporting more complex chemistry and improving the efficiency of technology transfer from laboratory to plant. At the same time, we continue to build on our experience in handling demanding chemical processes, regulatory expectations and customer-specific requirements. Our objective is to remain a responsive and technically strong CDMO partner for companies developing innovative molecules, while ensuring that projects are managed with the reliability, quality and industrial discipline required by the pharmaceutical industry.