In the world of pharmaceutical innovation, the need for precise and efficient drug delivery systems is paramount. At Ascendia Pharmaceutical Solutions, we are proud to lead the way in nanosuspension formulation development and manufacturing services, leveraging the sophisticated Ascendia’s Nanomilling technology. This customized state-of-the-art equipment made by Netzsch allows us to cater Ascendia’s NanoSol® technology to complex nanosuspension pharmaceutical needs, providing scalable, high-quality solutions for drug developers. Let me walk you through our capabilities and the advantages we bring to the table.
The Power of Nanomilling Technology
Nanomilling technology is at the heart of our sterile nanosuspension development services. This state of the art equipment made by Netzsch enables Ascendia to create nanosuspensions by grinding insoluble molecules into nano-sized particles, ensuring improved solubility and bioavailability of insoluble active pharmaceutical ingredients (APIs). At Ascendia, we employ four distinct configurations of the Nano-milling equipment made by Netzsch:
- DeltaVITA 1: Ideal for research and development, this system handles volumes ranging from 1 to 100 mL, perfect for screening and early-stage studies with small API quantity.
- DeltaVITA 15-300: Equipped with two grinding chambers (15 mL and 300 mL), this configuration bridges the gap between R&D and GMP manufacturing, allowing flexibility and scalability for batch size ranging from 50 mL to 1 liter.
- DeltaVITA 600: Designed for sterile GMP manufacturing, this system can process from 1 liter to up to 100 liters with dilution for sterile nanosuspension with customized design using 25 L and 100 L reactors in combination with in-line homogenizers, meeting the demands of small to media commercial production of sterile nano and micron-suspensions.
- DeltaVITA 60000: Designed for large scale manufacturing, this system can process from 100 liter to up to 4,000 liters, meeting the demands of large-scale commercial production.
Each of these systems is housed in ISO-classified cleanrooms, ensuring strict environmental control and aseptic processing. This setup minimizes the risk of cross contamination and maintains the integrity of sensitive drug formulations
Aseptic Processing: Precision and Protection
Aseptic processing is critical for the development of injectable formulations, where sterility is non-negotiable. At Ascendia, our sterile nanosuspension services are meticulously designed to protect products from environmental and microbial contaminations. Our processes include:
- Environmental Control: Our ISO-classified cleanrooms ensure that the entire process—from blending APIs in tanks to filling vials—is conducted under aseptic conditions.
- Seamless Scalability: With the Nanomilling capability, we can seamlessly transition from small-scale R&D to large-scale GMP manufacturing, providing end-to-end support for drug developers.
- Sophisticated Cleaning Protocols: Maintaining aseptic conditions requires rigorous cleaning validation. Our expertise in equipment assembly and maintenance ensures optimal performance and sterility.
A Competitive Edge from Ascendia Pharmaceutical Solutions
Ascendia’s early adoption of nanomilling technology has positioned us ahead of other CDMOs. Post-pandemic, acquiring and customizing such sophisticated equipment has proven challenging, but our foresight and investment have given us a significant advantage. Many competitors are just beginning to integrate this technology, while we have already established proven processes and expertise.
This head start allows us to offer:
- Streamlined Operations: Decades of experience with aseptic manufacturing and nanosuspension technology.
- Faster Development Timelines: Our established processes reduce the time required to bring products from R&D to commercialization.
- Unmatched Scalability: Whether you need small batches for clinical trials or large volumes for market supply, we’ve got you covered.
Meeting Customer Needs
Our nanosuspension development and manufacturing services cater to clients at various stages of their drug development pipeline. Most commonly, customers approach us during preclinical, Phase I or Phase II clinical trials. These clients often seek scalable solutions to transition into Phase III and eventually to commercialization. The types of products we work with include:
- Long-acting injectables for reduced dosing frequency and improved patient compliance.
- Complex generics and 505(b)(2) formulations that bypass extensive early-phase trials.
- Sterile suspension or sterile nanosuspension for IV, intramuscular, subcutaneous, intraocular, ophthalmic, topical, and oral routes of administration.
For injectables, sterility is paramount. Our expertise in aseptic processing ensures that every step, from blending to filling, adheres to stringent controls of bioburden, sterility, and endotoxins.
Why Choose Ascendia?
The combination of cutting-edge technology, experienced personnel, and robust processes makes Ascendia a trusted partner for drug developers. By choosing us, you benefit from:
- Proven Expertise: Years of experience with nanomilling technology and aseptic manufacturing.
- Comprehensive Support: From early-stage development to commercial production, we provide tailored solutions.
- Quality Assurance: Rigorous SOPs and environmental controls ensure the highest quality standards.
Partnering for Success
At Ascendia Pharmaceutical Solutions, we are committed to delivering innovative solutions that meet the evolving needs of the pharmaceutical industry. With our nanomilling services and state of the art customized Netzsch Mill equipment, we are helping to redefine drug delivery and patient care. To learn more, explore our collaboration with Ascendia, please contact us today to discuss your project needs.
Together, let’s make a difference in healthcare innovation.