With deep scientific expertise, we guide you and your molecule through the challenging terrain of early and late phase development.
Guiding. Crafting. Overcoming. We'll create the best route to clinic for you.
We guide you on the best route to the clinic with comprehensive, integrated development and manufacturing services, supporting the entire workflow required to make your drug substance available for trials and market authorization.
Our science-led team crafts the foundation for successful pharmaceutical product development, helping turn your compounds that show promise in the laboratory into effective and safe products.
Using the right standards at the right development phase, we have a dossier-oriented approach delivered by a team with long-standing regulatory knowledge to support successful regulatory filings.
We have world-class process development capabilities that support your drug substance production needs for pre-clinical testing.
Our process R&D team can develop and scale up your manufacturing process in our GMP Kilolab and state-of-the-art GMP pilot plant facilities, supporting your toxicology and clinical studies with batch sizes up to 50 kg.
In early clinical development, speed of delivery is vital. When an alternative synthesis route is required because of safety reasons, efficiency or cost reduction, our team can develop more efficient synthetic routes with a reduced number of process steps, starting from lower-cost raw materials.
We can perform route scouting, route comparison, and development and scale-up of a new synthesis route for your drug substance. Our experts will screen multiple synthesis routes to identify the most appropriate pathway for your molecule.
With market-leading crystallization process development capabilities, we design crystallization programs that provide highly detailed information and full control over your drug substance’s bulk properties. For early-stage compounds, we can set up small-scale crystallization screening experiments.
We develop manufacturing and crystallization processes in parallel to optimize yield, flowability, particle size and/or bulk density, and facilitate downstream processing and formulation.
Early in your program, we prioritize the development of final purification stages, including the crystallization process as these are more likely to have a high impact on the drug substance impurity profile and other critical quality attributes such as solid-state properties.
Working diligently to your timescales, we understand the importance of scaling up drug substance production rapidly and effectively to meet your deadline.
Our team of process experts excels at taking innovative manufacturing processes developed in the laboratory into the pilot plant and on to larger-scale production.
Accuracy, efficiency and speed are the foundation of every scale-up project we undertake to help our customers succeed.
Meeting the demands for the development of the highest-quality drug substance and providing the data required for regulatory approval, our analytical laboratories are equipped with a wide range of highly advanced technologies that are capable of precision drug substance assessment and characterization.
We develop and validate all methods up to the standards required for the stage of development to create efficiency and a more economical approach to your project.
Our analytical sciences team collaborates closely with process chemists to develop robust methods that support development. We have special expertise in detecting and quantifying impurities in drug substances and tracking these back to their point of origin.
We also offer the skills and capabilities required to support the development of nanomedicines and other heterogeneous products from process chemistry support via validation, to release and stability testing.
We perform quality control analytical testing of active pharmaceutical ingredients.
All analytical work is performed using state-of-the-art, GMP-qualified equipment and facilities and we offer release and stability testing of drug substances.
The structure of a drug substance determines the disease targets with which it can interact and its therapeutic function. It is critical to precisely determine the molecular structure of the drug substance throughout the development process.
In addition, the most effective way of determining the accuracy of a manufacturing process is to confirm the molecular structure of the drug substance produced.
We use a variety of techniques for molecular structure confirmation, including:
We have techniques to analyze powder properties, including:
Our solid-state research team investigates the form of your drug substance aiming to identify a stable salt and/or polymorphic form, with acceptable bioavailability and bulk properties. We design crystallization processes consistently to produce the desired form. Our capabilities include:
Drug substance stability studies, under real-time and accelerated conditions, are essential to determine the storage conditions and retest date of your drug substance.
We have the capabilities to evaluate drug substance stability at various temperatures and humidity levels as requested by the regulatory agencies.
Our ICH stability storage facilities are fully secured with 24/7 electronic monitoring, an alarm system and backup power.
Our manufacturing operations offer a comprehensive range of services designed to support the rapid scale-up and manufacture of virtually all the chemistries needed for active ingredients, including hydrogenations, carbonylations, cryogenic reactions and metal-mediated synthesis.
We have deep experience with long synthesis routes and the production of complex chiral molecules.
Our plants are carefully engineered for the supply of GMP and non-GMP batches for toxicology studies, early and late-stage clinical trials, and low-volume commercial manufacturing (< 1MT).
We are equipped to do gravity chromatography and preparative HPLC at up to 20kg input scale. In addition, we can perform other niche technologies under GMP, including ion-exchange chromatography and short path distillation.
Ardena offers a wide array of chromatographic purification techniques. While the goal of every process chemist is to eliminate chromatographic purification steps, this is often not possible in early clinical development. In order to enable the delivery of multi-kg quantities of high-quality drug substance, chromatographic purification of intermediates or final drug substance may be required.
Ardena has capabilities to perform gravity chromatography with batch sizes up to 20 kg/run. For more complex purifications, Ardena offers preparative HPLC. We employ 4 prep-HPLC systems (Novasep and Hypersep) with 15 cm, 20 cm and 30 cm diameter columns. We have huge experience in the purification of complex mixtures from synthesis or derived from natural products.
For charged (bio)molecules, Ion Exchange Chromatographic (IEC) is a highly efficient purification technique. Ardena has expertise in using IEC for the purification of mono- or poly-sulfonate, phosphate, carboxylate derivatives of carbohydrates, cyclodextrines and other small and large molecules.
We run IEC under GMP using GE Bioprocess system with columns up to 20 cm.
Ardena has the capacity for ultra- and nanofiltration of small molecules, (bio)conjugates, polymers, and nano- or micro-particles. This enables us to remove organic impurities and solvents, salts, and to carry out buffer exchanges for your product.
Ardena offers short path distillation for the purification of very high boiling and thermally labile compounds. We perform short path distillation to meet research and GMP requirements. We have capacity to purify up to 100 kg per 24 hours.
Ardena’s drug substance unit has capabilities and expertise in the manufacture of highly potent Active Pharmaceutical Ingredients (HPAPI), including steroids. Our production facility has containment capabilities that comply with Occupational Exposure Band C (0.1-1 mg/m3) requirements.
Our expert team members share their deep, scientific understanding and insights into drug substance development and manufacturing.
Get in touch to see how we can craft your path to the clinic with dedicated capabilities.
Using the right standards at the right development phase, our comprehensive program management services streamline your small molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your large molecule drug development.
Using the right standards at the right development phase, our comprehensive program management services streamline your nanomedicine drug development.