You don't want to gamble with your drug development timeline or its success by making the wrong decisions in your drug development process – whether it’s small molecules or biologics. When you complete the formulation and are ready to advance to the next stage, it is risky passing it off to a second CDMO.
By Robert Bloder
It’s can even be riskier to take it in-house to conduct Phase II, Phase III, and manufacturing. You can increase your odds for success if you partner with a CDMO who is “all in” on its commitment to create a seamless and custom process for each project.
Taking this all-in-one approach allows the manufacturing team to get up to speed on the formulation, the project, and everything related to the overall timeline quicker and with greater confidence. That is the commitment we have made at Ascendia Pharmaceutical Solutions. Our single partner approach provides economies of scale up because there is efficiency in terms of moving the process faster by eliminating speedbumps.
Bottom Line: You Meet Timelines Sooner
Fewer delays means fewer days lost, and, money saved in developing a drug product. A single-partner approach ensures you have the expertise of developing the formulation with full context by the team that has done the previous work, meaning they are completely familiar with all facets of the process leading up to that point. A separate CDMO that focuses only on a formulation is only interested in getting that formulation to work - meaning they're not as concerned with the concept of how it may transfer over to the final manufacturing process.
This is particularly true when working with lipid nanoparticles (LNPs) and developing biological drugs, such as gene therapies, stem cell therapies, and monoclonal antibodies. For example, viscosity of injectable drugs, while always a consideration, is not as prohibitive an issue during the formulation process. If not optimized, however, it can lead to significant problems that could lead to manufacturing delays and additional costs.
When all the cards are on the table, it is clear for a specialty CDMO such as Ascendia Pharmaceutical Solutions to see how a formulation will or will not slow down a manufacturing process. By taking a wholistic approach to the formulation alongside all the other elements involved, it’s easier to determine if aspects such as stability or viscosity of formulation might be an issue. This is not necessarily something that segmented CDMO partners would notice – or even report if they did – whereas a single-partner provider would take all of that into consideration from the early stages.
Understanding this point of view allows Ascendia to develop a formulation that's going to be the most efficient throughout the entire drug development timeline, cycle, and ecosystem. So, this saves time and money, and increases its chance for success. By having all the scientists who developed a formulation collaborating throughout the process, it is easier to determine immediately whether there is a snag that might cause any delays. By working together, they can maximize the likelihood of meeting goals throughout the entire formulation process, as well as during manufacturing.
Ascendia is ‘All-In’ and Ready to Handle Your Formulations
One thing to keep in mind throughout 2023 is that Ascendia may very well be the only CDMO in North America with the manufacturing equipment and processes – as well as the nanotechnologies – to take LNPs from pre-reformulation all the way through Phase II or Phase III. No other CDMO in our geography can do that right now. Delays in manufacturing mean that any new-comers to these new technologies are months away from even starting. Whereas companies looking to start investments in this equipment simply can’t right now, Ascendia is ready to go NOW with the equipment and expertise you have come to expect from our team.
Our all-in-one attitude as “one-stop-shop” led us to expand our manufacturing facility with the latest technology and equipment. Included is a platform to enable the controlled and precise assembly of LNPs. Ascendia can now efficiently advance a development program to cGMP manufacture of first-in-human clinical materials.
Lipid nanoparticles are gaining importance in the gene therapy realm of drug development. Beyond the obvious barrier of entry for any other company interested in offering these services being the equipment, there is still a mountain of experience to climb before they are ready to compete with Ascendia. Our scientists have been in the industry for over 20, 30, and even 40 years, so we understand the challenges with formulation and drug -development process. We're using that experience to extend the same level of consistency in service and quality to LNPs.
Simply, Ascendia is Your Partner of Choice for LNP Projects
We are one team that is experienced, but more importantly, dedicated to solving the problem. The level of customer service Ascendia brings to your project is unparalleled – and paramount to your success. We have the intelligence and the wherewithal to develop LipidSol, which is building off our other three nano technologies to solve your development problems, especially related to LNPs. Our team is involved in the day-to-day activities at Ascendia and they have high-level expertise from around the industry. From the very beginning to the very end, they make themselves available 24/7 to ensure the project takes off and is executed successfully.
We often have customers say, “We just can't get this formulation to work” when they meet our team but Ascendia has been able overcome their hurdles. That kind of expertise at that level will just naturally bleed into success in the manufacturing process, too. When it comes to trusting Ascendia with your lipid nanoparticle projects, it's not just about the capital equipment outlay, it's the investment in the personnel and expertise at all levels – including the cGMP manufacturing stage.
Ascendia is all-in and we have all our cards on the table. We’re ready to give you a winning to give you a winning hand. Contact us to schedule your tour of newly-finished facilities!