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.
The solid form selected for an active pharmaceutical ingredient can influence solubility, dissolution, stability, manufacturability and downstream process development. At Cambrex, we provide phase-appropriate solid form screening to identify and characterize potential forms, evaluate their developability and understand solid-state risks before they affect later development.
At our Edinburgh facility, dedicated solid-state chemistry laboratories support polymorph, salt, co-crystal and broader solid-form investigations, with screening integrated with solid-state characterization and downstream crystallization process development.
APIs can exist in multiple crystalline or amorphous forms, including polymorphs, salts, co-crystals, hydrates and solvates. These forms can have different physicochemical properties and different implications for development, processing, and storage.
We design solid form screening programs around the molecule, development phase, available material and program requirements. Studies are structured to:
The objective is not simply to identify additional forms. It is to develop the solid-state understanding needed to select an appropriate form and anticipate the risks involved in advancing it.
Polymorphism can affect both API performance and manufacturability. Our polymorph screening studies investigate the crystalline landscape of an API to identify forms suitable for development while detecting alternative forms that could create risks during isolation, processing or storage.
Programs can investigate:
Experimental approaches include broad crystallization screening across solvents and conditions, amorphization studies, competitive slurry experiments and structural confirmation using techniques including single-crystal X-ray diffraction or electron diffraction.
This understanding supports selection of a developable form while identifying solid-state behavior that may require additional control during crystallization, isolation, handling or storage.
Salt formation can be used to modify properties including solubility, dissolution rate, melting point, hygroscopicity, and physicochemical stability. Our rational approach to salt screening considers factors including pKa, intended route of administration and safety when selecting potential acidic or basic counterions.
Salt screening programs can include:
The extent of screening can be adapted to development phase and program objectives, from identifying a viable salt during earlier development to broader investigations that support later-stage development and intellectual property strategy.
Co-crystals provide another route for modifying the physicochemical properties of an API without changing the chemical structure of the active ingredient. Appropriate pharmaceutically acceptable co-formers may provide opportunities to modify properties such as solubility, stability and bioavailability.
Our co-crystal screening programs can incorporate:
The resulting data help determine whether a co-crystal offers a viable development option and how candidate forms compare with other solid-form strategies.
Solid form selection depends on understanding not only which forms can be generated, but also how those forms differ and behave.
We support screening programs with a range of solid-state characterization capabilities, including:
Our Edinburgh team can also support crystallization screening for challenging molecules, chiral resolution screening, peptide crystallization screening, high-throughput screening for process design, amorphous solid dispersion screening and investigative powder-property analysis where required.
Solid form screening establishes the knowledge needed to select a target form. The next challenge is developing a process that reproducibly generates that form with appropriate material attributes.
By integrating solid-form screening with crystallization process development, we can apply knowledge generated during screening to decisions around:
This connection between screening and process development helps translate solid-state understanding into the practical controls needed for subsequent scale-up and manufacturing.
We perform solid form screening at our Edinburgh, UK facility, where dedicated laboratories support solid-form screening, characterization and crystallization development.
The team can also support compounds requiring specialized handling and containment, including highly potent APIs, extending our solid-form screening capabilities to programs where occupational exposure considerations affect how development work is performed.
Our Edinburgh facility supports solid-form screening and characterization, small-molecule and peptide crystallization, analytical method development, controlled crystallization reactors, process analytical technology (PAT) and design of experiments (DoE).
Projects are supported by our scientists responsible for study design, data interpretation, solid-form screening and crystallization process development, providing continuity between experimental screening and recommendations for subsequent development.
Whether the immediate requirement is to understand polymorphism, identify a suitable salt or co-crystal, investigate an unexpected form, or establish a foundation for crystallization development, we can design a solid form screening program around your molecule and its development stage.
Peptide crystallization offers a powerful approach to improving purification, stability and process efficiency in peptide manufacturing. In this webinar, Cambrex’s Hannah McLachlan explores the advantages of crystallizing peptide fragments and whole peptide compounds, including the use of high throughput screening to accelerate development and guide process optimization through real-world case studies.
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.