Expertise across diverse small molecule applications
Small molecule programs can encounter very different chemistry, containment, purification, filtration, supply, and scale-up challenges. We bring together multi-disciplinary specialist teams and manufacturing capabilities to help clinical-stage CMC and supply leaders identify the right development path, manage risk, and plan for reliable progression toward commercial supply.
High-potency API manufacturing and containment
Our integrated HPAPI services combine expertise in complex chemistry, process development, specialized containment strategies, and scalable manufacturing to safely develop and produce highly potent compounds up to SafeBridge Category 4/OEB 5. From gram-scale development through commercial batch sizes of approximately 30 kg, we apply the expertise, equipment, and infrastructure needed to support seamless scale-up while minimizing risk. Backed by an integrated global manufacturing network and supply chain, we help ensure reliable sourcing of raw materials, intermediates, and other critical materials to support long-term commercial success. We have 35+ years of experience developing and manufacturing high-potency APIs with proven containment expertise and scalable production.
Specialized manufacturing solutions for linker-payloads
Linker-Payload manufacturing and development in Madison, Wisconsin, provides scalable custom linker-payload manufacturing for ADC programs, from gram to multi-kilogram batch scale. Through an integrated ADC supply chain, we streamline development with global sourcing, custom and registered starting materials, GMP payload manufacturing, and advanced intermediates from a single partner. Combined with linker-payload manufacturing, bioconjugation services, and coordinated program management through a single point of contact, we help simplify complex ADC development and accelerate progression from development to commercialization. With experience in established clinical payloads such as MMAE and Exatecan, as well as emerging novel constructs, we help sponsors reduce risk, enhance supply chain resilience, simplify program management, and build a strong foundation for long-term commercial success.
Achieve high purity, selectivity, and process performance
Our team combines expertise in complex chiral synthesis, purification strategies, and process and analytical development and optimization to maximize yield, improve selectivity, and achieve high-purity APIs. By integrating chemistry, analytical, and process expertise from the outset, we develop robust, scalable manufacturing processes that reduce development risk, accelerate scale-up, and support successful commercialization. Our extensive toolbox of purification strategies ensures efficient impurity characterization and removal.
Optimize particle properties for reliable manufacturing performance
Our particle engineering and crystallization experts develop robust processes that optimize crystallization, particle size distribution, and solid-state properties to improve manufacturability, filterability, and control of critical particle characteristics. Using high-throughput experimentation, digital process tools, and advanced particle characterization, we build process understanding, reduce filtration and scale-up risk, and support consistent manufacturing performance. Our particle engineering and crystallization expertise optimizes particle characteristics to improve manufacturability and reduce solubility and filtration risk.
Secure, compliant manufacturing for controlled substance development and production
At our licensed facility in Schaffhausen, Switzerland, we combine expert process development and regulatory teams, analytical capabilities, and manufacturing experience required to support controlled substance programs from development through commercial manufacturing. As one of the few facilities in Europe equipped to handle narcotics, we maintain an active Swissmedic license backed by a decade of refined chain-of-custody procedures, stringent security measures, real-time inventory management, and comprehensive regulatory support. Biennial Swissmedic inspections and internal self-inspections help ensure ongoing audit readiness and compliance throughout your program. Our active Swissmedic license enables secure, compliant development and manufacturing of controlled substances largely overlapping with DEA Schedules II–IV.
Accelerate first-in-class therapies from clinical development to commercialization
Our experts develop robust, scalable processes for highly novel and first-in-class small molecules, applying deep synthetic organic chemistry expertise to solve complex development challenges. We build the right foundation with a phase-appropriate approach to process development, analytical methods, quality systems, and regulatory support that is designed to be future-proof, enabling a seamless transition from clinical development to commercial manufacturing. With flexible small- to mid-scale manufacturing capabilities and the optionality to scale up or scale out as your program evolves, we support changing clinical and commercial requirements while minimizing technology transfers, cost, and risk. Our team has extensive experience developing and manufacturing orphan drugs, delivering the speed, agility, and flexibility required to support fast-track development programs.
Customized PEGs for your specific application
When off-the-shelf PEG options are not suitable, custom solutions can provide greater control over process performance and product specifications. We provide GMP synthesis of custom activated PEGs for use as linkers, spacers, and PEGylation components, with scalable commercial manufacturing from small-scale batches to hundreds of kilograms. Combined with support for both primary and secondary supply strategies, we help ensure reliable supply throughout the product lifecycle. Our team has more than 25 years of experience in custom PEG functionalization, supported by advanced analytical capabilities, in silico tools, and deep regulatory expertise.
Advance your small molecule programs with confidence
Clinical-stage teams need more than manufacturing capacity. They need a partner that can identify risk early, connect technical decisions to future manufacturing requirements, and maintain clear communication across CMC, quality, supply, and procurement stakeholders.
- Specialist process and purification expertise: Address complex synthesis, impurity, filtration, crystallization, and processing challenges.
- Integrated analytical support: Connect process development and analytical insight to accelerate decisions and strengthen process understanding.
- Digital and in silico tools: Support route assessment, process optimization, and more predictable scale-up.
- Phase-appropriate quality: Apply the right level of development and documentation for the current clinical stage while planning for future needs.
- Flexible manufacturing pathways: Support changing volume, complexity, containment, and supply requirements.
- Direct expert collaboration: Maintain transparent project governance and technical access throughout the engagement.
Our small molecule track record of success
35+
Years of experience in small molecule development and production
Single digit nanogram containment
SafeBridge® Certified to support HPAPI handling
Active controlled substance license
Swissmedic license and inspected chain of custody
GreenSpeed™ integration
Environmental and efficiency considerations embedded in every process
A global footprint
We are a single organization with a global network to deliver CDMO services across all stages of the molecule value chain.
A collaborative approach to small molecule development and manufacturing
Every program begins with a focused discussion of your molecule, stage, technical risks, supply needs, and future objectives.
- Build the right foundation: The first step includes sharing available process, analytical, stage, volume, timeline, and supply information, enabling our team to conduct an initial feasibility assessment supported by in silico modeling tools.
- Identify risks and development priorities: Our experts review route knowledge, process gaps, equipment fit, impurity and filtration risks, analytical readiness, and scale-up considerations.
- Define the execution pathway: We align on development, analytical, transfer, manufacturing, quality, and supply activities appropriate to the program stage.
- Advance with transparent governance: Our teams work through defined milestones, technical reviews, risk management, and next-step planning with direct access to project and scientific experts.
- Evaluate sustainability opportunities: Our team assesses raw materials and solvents while calculating and tracking the initial Process Mass Intensity (PMI) score throughout process optimization and scale-up.
After you submit an inquiry, our goal is to connect you with the appropriate expert and provide an initial response within approximately one week.
Explore small molecule CDMO capabilities
Related resources
- Webinar: Solving synthesis challenges — small molecule CDMO strategies
Understand approaches for complex synthesis, process development, purification, and scale-up.
- White paper: Handling protocols and key considerations for HPAPIs
Review containment, handling, safety, and qualification considerations for high-potency programs.
- White paper: Sustainability by design in API manufacturing
Explore how process-development choices can improve efficiency, material use, and long-term manufacturing performance.
- White paper: Selecting a CDMO for custom activated PEGs
Learn what to evaluate when selecting or transitioning a custom PEG manufacturing partner.
Frequently asked questions
What types of complex small molecules do we support?
Our expertise spans a broad range of challenging small molecule applications, including HPAPIs, controlled substances, orphan drugs, difficult-to-purify APIs, particle engineering and filtration challenges, linker-payloads, and custom PEGs. Specialized development and manufacturing capabilities help address the unique scientific and technical requirements of each application.
Can we support programs from early development through commercial manufacturing?
Yes. Our development and manufacturing capabilities are designed to support programs from early process development through clinical and commercial production. By considering future manufacturing requirements early, we help establish scalable processes that can grow with demand while minimizing the need for additional technology transfers. We also leverage AI-enabled route scouting and our proprietary SYNTHIA® retrosynthesis software.
How we reduce risk during process development and scale-up?
We combine deep process development expertise with advanced, in-house analytical capabilities, high-throughput experimentation, and in silico enabled process modeling to identify challenges early and improve process understanding. This approach helps optimize process performance, increase scale-up confidence, and reduce development and manufacturing risk.
How we support regulatory and quality requirements?
Our teams provide phase-appropriate development, analytical, and quality support throughout the product lifecycle. Regulatory expertise includes support for CMC documentation, submission preparation, and compliance with global regulatory requirements, helping clients advance programs efficiently through development and commercialization.
How we ensure supply chain reliability?
Integrated supply chain capabilities, global manufacturing resources, and proactive planning help support continuity of supply throughout development and commercialization. Depending on the application, support may include sourcing of starting materials, advanced intermediates, secondary supply strategies, and coordinated manufacturing across sites.
What makes our approach different from other CDMOs?
We combine specialized small molecule expertise with advanced, digital process development, integrated analytics, scalable manufacturing, and transparent project management. Digitalized technology transfer, in silico process modeling, and route optimization help identify risks early and support efficient scale-up. Through direct expert-to-expert collaboration, we develop robust, future-ready processes that reduce risk, accelerate timelines, and support long-term commercial success.