IND submission is a major milestone in the life of your drug. We can provide all supporting analytical data to help ensure a smooth application process.
We have the expertise, flexibility, and resources to provide a full range of pharmaceutical API custom development services at every stage of the lifecycle.
We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities.
Drug substance tech transfer sounds so simple on the surface, but it’s a complex activity carrying a number of technical, regulatory, and quality risks. Cambrex specializes in seamless technology transfers and quick onboarding to keep your program on track.
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs.
Cambrex offers cutting-edge capabilities in peptide development and manufacturing, combining innovative technologies, diverse applications and specialized expertise to meet the growing demand for peptide-based therapeutics.
At Cambrex, we provide a range of technologies equipped to solve your API manufacturing challenges, and we are flexible enough to handle the most complex molecules.
You can rely on our extensive portfolio of analytical development solutions and testing services to rapidly advance your molecule for the greatest chance of success.
Cambrex’s experienced analysts are well-equipped to ensure microbial testing is of the highest quality for our customers and delivered with a quick and reliable turnaround.
We’re solid state chemistry experts who can deliver timely, phase-appropriate solutions to optimize the physical stability of your API, develop a more bioavailable formulation or overcome other challenges.
Cambrex and Q1 Scientific’s stability storage and sample management capabilities provide a variety of pharmaceutical storage conditions, with walk-in and reach-in chambers that meet all ICH Q1A requirements.
Cambrex offers extensive development services tailored to meet your drug product needs in early development. From pre-formulation to Phase II, we ensure your products are developed with speed, flexibility, and quality in mind.
Whether you need rapid development, flexible manufacturing solutions, or high-quality production, Cambrex is your trusted partner for advancing your drug product from concept to the clinic.
Cambrex is here to support you in early-phase development. Our development experts apply their ingenuity and skill to address your unique challenges.
Our teams of creative problem-solvers work closely with you to accelerate drug development timelines, optimize processes, and meet regulatory requirements.
We understand that the commercial phase of drug development can be challenging, especially when it comes to manufacturing at scale and meeting changing market demands.
Cambrex is a leading global supplier of more than 70 generic APIs, as well as intermediates and derivatives.
Effective API process development integrates route design, process chemistry and manufacturability to establish scalable, controllable routes from early development through commercial readiness. For small molecule APIs, early development decisions define long-term outcomes related to scalability, impurity control, process safety, solid-state behavior and regulatory readiness, making lifecycle alignment essential from the outset.
Our API process development approach operates as a connected decision framework rather than a series of isolated activities. Each stage builds process understanding that reduces uncertainty, clarifies risk and strengthens readiness for scale-up, GMP manufacturing and technology transfer.
Robust API processes deliver predictable performance under real manufacturing conditions, not only optimized laboratory environments. As development advances, chemistry must tolerate increasing scale, equipment variability and operational constraints while maintaining control of yield, impurity profile and physical form.
Process robustness emerges when process chemistry, impurity control, solid-state science, analytical development and process safety evolve as an integrated system. Reaction conditions influence impurity formation and downstream purification. Isolation and crystallization govern physical-form stability, particle attributes and handling behavior. Process safety considerations define feasible operating boundaries, while analytical capability develops in parallel to support increasing process understanding and regulatory expectations.
When these disciplines remain aligned, development decisions are better positioned to support reliable scale-up, reproducible GMP execution and effective technology transfer without requiring significant late-stage redesign.
Robust API process development begins with clear intent around scale, impurity strategy, physical form and manufacturability. Cambrex aligns synthetic route design, process optimization, scale-up, solid-state understanding, analytical development and process safety within the practical constraints of manufacturing and regulatory expectations.
By connecting early process R&D decisions with downstream GMP execution, this integrated approach addresses key development considerations related to:
Addressing these considerations during development reduces the potential for late-stage rework while building the process understanding required for scale-up, technology transfer and long-term commercial manufacturing.
Our API process development lifecycle operates as a unified system that connects early scientific exploration with commercial manufacturing readiness. Route scouting, process optimization and scale-up define the core development pathway, while analytical development, impurity control, process safety and solid-state science operate in parallel to inform critical decisions throughout development. Technology transfer then carries this established process knowledge into reproducible GMP manufacturing.
This integrated model aligns each stage and supporting discipline with manufacturing and regulatory expectations, helping ensure that processes are scalable, controllable, commercially viable and transferable.
Our connected process development capabilities include:
Together, these capabilities provide a connected framework for developing API processes that can progress from early chemistry through commercial manufacturing without losing continuity in process understanding or control.
Cambrex combines deep process chemistry expertise with integrated development and manufacturing capabilities to develop API processes designed for lifecycle performance.
Our development teams operate in direct alignment with manufacturing, grounding technical decisions in real operating conditions rather than theoretical scale-up assumptions. This manufacturing perspective helps ensure that process understanding evolves alongside scale, equipment requirements and regulatory expectations.
This integrated model enables:
Cambrex also integrates regulatory considerations throughout development so that process knowledge, control strategies and supporting data remain aligned with applicable ICH expectations and the requirements of major regulatory authorities as programs advance.
The result is a more complete understanding of how the process performs, why variability occurs and how that variability can be controlled throughout development and manufacturing.
Related Topics
Need to evaluate how route selection, process optimization, impurity control, process safety or solid-form considerations could affect your program? Connect with a Cambrex API process development expert.
In our collaboration with Sanofi, we developed a telescoped continuous flow manufacturing process for a key bromopyridine intermediate by integrating continuous flow chemistry, process analytical technology and scalable crystallization development, improving process efficiency, enhancing operational control and delivering the target intermediate in high purity through a streamlined three-step process.
Watch our recent webinar to learn about a new biocatalytic process developed at Cambrex Charles City in which we highlight the collaborative efforts of process chemists and engineers to develop an effective byproduct removal strategy.
What activities are included within API process development?
API process development establishes the manufacturing process used to produce an active pharmaceutical ingredient. Activities can include route selection, process optimization, impurity control, purification strategy, solid-form development, analytical support, process safety evaluation and scale-up. These activities work together to establish a process that can consistently deliver the required product quality while supporting technology transfer, GMP manufacturing and long-term commercial supply.
How do you determine whether an API synthesis route is scalable?
Scalability requires evaluating more than laboratory yield. Development teams consider reaction robustness, impurity behavior, process safety, raw material availability, isolation performance and equipment compatibility. Heat and mass transfer, mixing, crystallization behavior, filtration and process variability may also change as scale increases. Understanding these factors during development helps determine whether a synthetic route can support reliable manufacturing execution.
What is the difference between route scouting, process optimization and scale-up?
Route scouting evaluates alternative synthetic pathways to determine which chemistry should advance. Process optimization develops the selected route by defining appropriate reaction conditions, operating ranges, impurity controls and manufacturing strategies, while scale-up evaluates whether this process understanding remains valid as equipment, volume and operational complexity increase. Together, these stages form the core API process-development pathway.
How are impurities controlled during API process development?
Impurity control begins with understanding how impurities form and how process conditions influence their behavior. Development teams evaluate reaction pathways, reagents, process parameters, workups and purification strategies to establish an understanding of impurity formation, fate and purge, while analytical data support the development and confirmation of controls capable of consistently delivering material that meets established quality requirements.
How does API process development reduce scale-up risk?
Processes can behave differently as reaction volumes, equipment and operating conditions change, creating potential challenges involving heat and mass transfer limitations, impurity shifts, reaction variability, filtration performance, crystallization behavior and material handling. Integrated process development identifies these risks while development flexibility remains available, allowing operating strategies and controls to be established before manufacturing scale is reached.
How can early process-development decisions influence manufacturing cost?
Many long-term manufacturing cost drivers are established during development. Yield, cycle time, solvent consumption, raw material selection, purification efficiency and process throughput can all influence cost of goods, and evaluating these considerations alongside process robustness helps identify improvements that can provide economic benefits throughout clinical and commercial manufacturing.
How does API process development support technology transfer?
Successful technology transfer depends on a process being sufficiently understood, reproducible and compatible with the receiving manufacturing environment. Process development establishes the data, operating ranges, analytical methods, impurity controls and technical knowledge required to reproduce the process at larger scale or at another manufacturing site, reducing reliance on undocumented experience and supporting more consistent GMP execution.
When should continuous processing be considered during API development?
Continuous processing may be appropriate when conventional batch approaches introduce challenges involving heat or mass transfer, hazardous reagents, highly exothermic reactions, unstable intermediates, cryogenic conditions or throughput. Evaluating these technologies early allows development teams to determine whether continuous processing offers meaningful technical, safety or manufacturing advantages before the process becomes more difficult to change.
How is process safety integrated into API process development?
Process safety considerations begin during early chemistry evaluation and become more detailed as the selected process advances. Thermal behavior, reaction hazards, material properties and operational risks are evaluated alongside process optimization so that safe operating strategies can be incorporated into the developing process, with more detailed characterization then supporting the definition of appropriate operating boundaries for scale-up and manufacturing.