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Payloads and API development and manufacturing services

Explore our diverse range of payloads and APIs tailored for nanoparticle formulations.

At Ardena, we go beyond just creating nanoparticles by offering a specialized service that seamlessly incorporates diverse payloads and APIs into your nanoparticles. By working with qualified vendors for these materials, we can ensure the highest quality and compliance with cGMP for your product.

This includes the integration of a large variety of compounds, such as:

Small molecule APIs, including prodrugs and cytotoxics
Proteins and polypeptides
Oligonucleotides, mRNA and DNA

Our nanomedicine expertise

Every nanomedicine is unique and has a different way of incorporating a payload.

Our nanomedicine team is experienced with a broad range of loading mechanisms, including:

Membrane loading
Active or remote loading
Passive loading
Surface modification, non-covalent or covalent
- Bioconjugation
- Click chemistry
- Electrostatic interactions
Coating
Cross-linking

We are also experienced in making targeted nanomedicines, for instance by conjugating antibodies or other targeting handles to the outer surface of the nanoparticles.

Our chemical process development

In addition to procuring commercially available drug substances and excipients, we can also develop chemical processes to manufacture the majority of small molecules under GMP. Our manufacturing operations offer a comprehensive range of services designed to support the rapid scale-up and manufacturing of virtually all the chemistries needed for active ingredients, including hydrogenations, carbonylations, cryogenic reactions and metal-mediated synthesis.

Our deep experience includes handling long synthesis routes and producing complex chiral molecules. We have successfully integrated the in-house manufacturing of custom complex (phospho)lipids, incorporating large-scale chromatographic purification steps.

Furthermore, we have expanded our capacity to handle highly potent APIs (HPAPIs) up to OEB 5 (Pharmtech scale) by establishing a dedicated laboratory for process and analytical development.

This addition complements our state-of-the-art pilot plant, allowing us to develop and deliver HPAPIs from gram to multi-kilogram batches.

Find our more about our Drug Substance services

Our analytical expertise

Our analytical experts have ample experience with the characterization of APIs such as small-molecule drugs, peptides, oligonucleotides and mRNA. Commercially available APIs that arrive at our site will be characterized to ascertain that they are of sufficiently high quality before further use.

Ardena performs scale-up and API manufacturing services,manufacturing of the API and our analytical team will works hand -in- hand with the process chemists to characterize the intermediate compounds and the final API. When the API meets the specified quality level, the API will be released such that it can be incorporated into the nanoparticle.

We have a broad range of techniques to analyze diverse payloads ensuring thorough characterization (composition, stability, structure) and compliance with regulatory standards.

These techniques include:

Small-molecule drugs: LC-UV/CAD/MS, NMR, IR
Peptide/proteins: LC-UV/MS, AAA, NMR, AF4/SEC-MALS, DLS
Oligonucleotides and mRNA: IPLC-UV/MS, qPCR, CGE (Fragment Analyzer), RiboGreen, NanoDrop