Nanomedicine development services | Ardena Nanomedicines

Technology transfer, process and scale-up development

At Ardena, we understand that successful development and scale-up demands a delicate balance of innovation, pragmatism and seamless technology transfer.

Our nanomedicine process development team is dedicated to developing phase-appropriate production processes in alignment with cGMP. We prioritize a unified approach by employing one team for both nanoparticle development and manufacturing, facilitating ease of communication and maximizing the efficiency of knowledge transfer.

Our nanomedicine process development process leverages a diverse array of cutting-edge techniques, including:

Flow manufacturing
Batchwise synthesis
Tangential flow filtration and ultrafiltration
Magnetic separation
Single-use purification systems
Bioburden-reducing filtrations
Spray drying
Microfluidics

Ardena is committed to staying at the forefront of technological advancements, continuously incorporating innovative techniques into our nanomedicine process development strategies. Ardena works with its clients to incorporate novel techniques tailored to each product’s unique requirements.

Within our cGMP-compliant manufacturing facilities, we possess the capability of processing volumes ranging from a few milliliters to up to several hundreds of liters of nanoparticle solution, employing both batch-type and flow manufacturing processes.

Our facilities are carefully designed to handle highly potent drug substances and can deliver nanosuspensions and nanoparticle solutions for further processing into finished drug products.

This end-to-end solution, coupled with our commitment to quality and compliance, positions Ardena as a trusted partner in the dynamic and evolving field of nanomedicine formulation and development.

Critical quality attributes and analytical methodology implementation

Recognizing that every nanomedicine is unique, we collaborate with our customers to define the critical quality attributes (CQAs) and specifications of their formulation early in the project. Together, we tailor our analytical techniques to ensure proper control and compliance with regulatory requirements through development, qualification and validation.

Our process includes phase-appropriate analytical method development and GMP-compliant validation, alongside release and stability testing following ICH guidelines.

Stability studies

Stability studies are critical to investigate the stability of the nanomedicine over time and can be used to set a shelf-life or retest period for a product. These stability studies are performed according to the ICH guidelines, and multiple stability chambers are available for testing the intended storage condition and several accelerated storage conditions.

Examples of the different storage conditions are shown below:

-20 ± 5°C
5 ± 3°C
25 ± 2°C / 60 ± 5% RH
30 ± 2°C / 65 ± 5% RH
40 ± 2°C / 75 ± 5% RH

In addition to monitoring the quality of the nanomedicine at common storage conditions, Ardena has specialist experience with related stability programs to ensure product integrity and performance:

Testing the influence of packaging materials
Conducting investigations for more severe accelerated conditions (i.e., forced degradation studies)
Evaluating the stability at conditions that best mimic the intended clinical use of the product.